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肺結核が疑われる成人の肺結核およびリファンピシン耐性診断におけるXpert Ultra検査対Xpert MTB/RIF検査

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References

References to studies included in this review

Berhanu 2018 {published data only}

Berhanu RH, David A, da Silva P, Shearer K, Sanne I, Stevens W, et al. Performance of Xpert MTB/RIF, Xpert Ultra, and Abbott RealTime MTB for diagnosis of pulmonary tuberculosis in a high-HIV-burden setting. Journal of Clinical Microbiology 2018;56(12):e00560-18. CENTRAL

Chakravorty 2017 {published data only}

Chakravorty S, Simmons AM, Rowneki M, Parmar H, Cao Y, Ryan J, et al. The new Xpert MTB/RIF Ultra: improving detection of Mycobacterium tuberculosis and resistance to rifampin in an assay suitable for point-of-care testing. Molecular Biology 2017;8(4):e00812-17. CENTRAL [DOI: 10.1128/mBio.00812-17]

Dorman 2018 {published data only}

Dorman SE, Schumacher SG, Alland D, Nabeta P, Armstrong DT, King B, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study. Lancet Infectious Diseases 2018;18(1):76-84. CENTRAL

Mishra 2020a {published data only}

Mishra H, Reeve R, Palmer Z, Caldwell J, Dolby T, Naidoo C, et al. Xpert Ultra and Xpert MTB/RIF for tuberculosis diagnosis in an HIV-endemic setting with a high burden of previous tuberculosis: a two cohort diagnostic accuracy study. Lancet Respiratory Medicine 2020;8(4):368-82. CENTRAL

Mishra 2020b {published data only}

Mishra H, Reeve R, Palmer Z, Caldwell J, Dolby T, Naidoo C, et al. Xpert Ultra and Xpert MTB/RIF for tuberculosis diagnosis in an HIV-endemic setting with a high burden of previous tuberculosis: a two cohort diagnostic accuracy study. Lancet Respiratory Medicine 2020;8(4):368-82. CENTRAL

Opota 2019 {published data only}

Opota O, Zakham F, Mazza-Stalder J, Nicod L, Greub G, Jaton K. Added value of Xpert MTB/RIF Ultra for diagnosis of pulmonary tuberculosis in a low-prevalence setting. Journal of Clinical Microbiology 2019;57(2):e01717-18. CENTRAL

Pereira 2020 {published data only}

Pereira GR, Barbosa MS, Dias NJD, Dos Santos FF, Rauber KA, Silva DR. Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis (TB) diagnosis in a city with high TB incidence in Brazil. Respiratory Medicine 2020;162:105876. CENTRAL

Piersimoni 2019 {published data only}

Piersimoni C, Gherardi G, Gracciotti N, Pocognoli A. Comparative evaluation of Xpert MTB/RIF and the new Xpert MTB/RIF Ultra with respiratory and extra-pulmonary specimens for tuberculosis case detection in a low incidence setting. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2019;15:100094. CENTRAL [DOI: 10.1016/j.jctube.2019.100094]

Wang 2019 {published data only}

Wang G, Wang S, Jiang G, Yang X, Huang M, Huo F, et al. Xpert MTB/RIF Ultra improved the diagnosis of paucibacillary tuberculosis: a prospective cohort study. Journal of Infection 2019;78(4):311-6. CENTRAL

References to studies excluded from this review

Abong 2019 {published data only}

Abong J, Dalay V, Langley I, Tomeny E, Marcelo D, Mendoza V, et al. Use of GeneXpert and the role of an expert panel in improving clinical diagnosis of smear-negative tuberculosis cases. PLOS ONE 2019;14(12):e0227093. CENTRAL

Acuna‐Villaorduna 2017 {published data only}

Acuna-Villaorduna C, Orikiriza P, Nyehangane D, White LF, Mwanga-Amumpaire J, Kim S, et al. Effect of previous treatment and sputum quality on diagnostic accuracy of Xpert® MTB/RIF. International Journal of Tuberculosis and Lung Disease 2017;21(4):389-97. CENTRAL

Ade 2016 {published data only}

Ade S, Adjibode O, Wachinou P, Toundoh N, Awanou B, Agodokpessi G, et al. Characteristics and treatment outcomes of retreatment tuberculosis patients in Benin. Tuberculosis Research and Treatment 2016;2016:1468631. CENTRAL [DOI: 10.1155/2016/1468631]

Adelman 2014 {published data only}

Adelman MW, Tsegaye M, Kempker R, Abeje T, Tesfaye A, Aseffa A, et al. Enhanced active TB case finding among people living with HIV: impact of a rapid molecular test (XPERT MTB/RIF). Journal of Investigative Medicine 2014;62(2):570. CENTRAL

Afshan 2019 {published data only}

Afshan G, Hussain M, Shafiq M. Sensitivity and specificity of Xpert MTB/RIF for diagnosis of pulmonary tuberculosis, detection of RIF resistance and its concordance with gene sequencing for RIF Resistance. International Journal of Medical Research & Health Sciences 2019;8(10):59-66. CENTRAL

Agizew 2017 {published data only}

Agizew T, Basotli J, Alexander H, Boyd R, Letsibogo G, Auld A, et al. Higher-than-expected prevalence of non-tuberculous mycobacteria in HIV setting in Botswana: implications for diagnostic algorithms using Xpert MTB/RIF assay. PLOS ONE 2017;12(12):e0189981. CENTRAL [DOI: 10.1371/journal.pone.0189981]

Agizew 2019 {published data only}

Agizew T, Chihota V, Nyirenda S, Tedla Z, Auld AF, Mathebula U, et al. Tuberculosis treatment outcomes among people living with HIV diagnosed using Xpert MTB/RIF versus sputum-smear microscopy in Botswana: a stepped-wedge cluster randomised trial. BMC Infectious Diseases 2019;19(1):1058. CENTRAL

Agrawal 2016 {published data only}

Agrawal M, Bajaj A, Bhatia V, Dutt S. Comparative study of GeneXpert with ZN stain and culture in samples of suspected pulmonary tuberculosis. Journal of Clinical and Diagnostic Research 2016;10(5):DC09-12. CENTRAL

Agustina 2019 {published data only}

Agustina B, Kartasasmita C, Hilmanto D. Comparison of GeneXpert MTB to Mycobacterium tuberculosis culture in children with tuberculosis. Paediatrica Indonesiana 2019;59(3):113-8. CENTRAL

Ai 2019 {published data only}

Ai JW, Zhou X, Xu T, Yang M, Chen Y, He GQ, et al. CRISPR-based rapid and ultra-sensitive diagnostic test for Mycobacterium tuberculosis. Emerging Microbes and Infections 2019;8(1):1361-9. CENTRAL

Akhter 2019 {published data only}

Akhter N, Sumalani KK, Chawla D, Rizvi N. Comparison between the diagnostic accuracy of Xpert MTB/Rif assay and culture for pleural tuberculosis using tissue biopsy. European Respiratory Journal Open Research 2019;5(3):00065-2019. CENTRAL

Alame‐Emane 2017 {published data only}

Alame-Emane AK, Pierre-Audigier C, Aboumegone-Biyogo OC, Nzoghe-Mveang A, Cadet-Daniel V, Sola C, et al. Use of GeneXpert remnants for drug resistance profiling and molecular epidemiology of tuberculosis in Libreville, Gabon. Journal of Clinical Microbiology 2017;55(7):2105-15. CENTRAL

Al‐Ateah 2012 {published data only}

Al-Ateah SM, Al-Dowaidi MM, El-Khizzi NA. Evaluation of direct detection of Mycobacterium tuberculosis complex in respiratory and non-respiratory clinical specimens using the Cepheid Gene Xpert® system. Saudi Medical Journal 2012;33(10):1100-5. CENTRAL

Albay 2016 {published data only}

Albay A, Guney M, Tekin K, Kisa O, Sig AK. Evaluation of the GeneXpert MTB/RIF assay for early diagnosis of tuberculosis and detection of rifampicin resistance in pulmonary and extrapulmonary specimens. Cukurova Medical Journal 2016;41(3):548-53. CENTRAL

Al‐Darraji 2016 {published data only}

Al-Darraji HA, Altice FL, Kamarulzaman A. Undiagnosed pulmonary tuberculosis among prisoners in Malaysia: an overlooked risk for tuberculosis in the community. Tropical Medicine & International Health 2016;21(8):1049-58. CENTRAL

Allahyartorkaman 2019 {published data only}

Allahyartorkaman M, Mirsaeidi M, Hamzehloo G, Amini S, Zakiloo M, Nasiri MJ, et al. Low diagnostic accuracy of Xpert MTB/RIF assay for extrapulmonary tuberculosis: a multicenter surveillance. Science Reports 2019;9(1):18515. CENTRAL

Alland 2015 {published data only}

Alland D, Rowneki M, Smith L, Ryan J, Chancellor M, Marie Simmons A, et al. Xpert MTB/RIF Ultra: a new near-patient TB test with sensitivity equal to culture. Topics in Antiviral Medicine 2015;23(E-1):37. CENTRAL

Alnimr 2014 {published data only}

Alnimr AM, Hassan MI. Potential of two nucleic acid amplification assays for quantifying mycobacterial load in respiratory and non-respiratory specimens: a prospective study. Diagnostic Microbiology and Infectious Disease 2014;78(3):237-41. CENTRAL

Alvarez 2015 {published data only}

Alvarez GG, Dyk DD, Desjardlns M, Yasseen AS 3rd, Aaron SD, Cameron DW, et al. The feasibility, accuracy, and impact of Xpert MTB/RIF testing in a remote aboriginal community in Canada. Chest 2015;148(3):767-73. CENTRAL

Alvarez‐Uria 2012 {published data only}

Alvarez-Uria G, Azcona JM, Midde M, Naik PK, Reddy S, Reddy R. Rapid diagnosis of pulmonary and extrapulmonary tuberculosis in HIV-infected patients. Comparison of LED fluorescent microscopy and the GeneXpert MTB/RIF assay in a district hospital in India. Tuberculosis Research and Treatment 2012;2012:932862. CENTRAL [DOI: 10.1155/2012/932862]

Alvis‐Zakzuk 2017 {published data only}

Alvis-Zakzuk NJ, Carrasquilla ML, Gomez VJ, Robledo J, Alvis-Guzman NR, Hernandez JM. Diagnostic accuracy of three technologies for the diagnosis of multi-drug resistant tuberculosis [Precisión diagnóstica de tres pruebas moleculares para detectar la tuberculosis multirresistente]. Biomedica 2017;37(3):397-407. CENTRAL

Andriani 2016 {published data only}

Andriani R, Burhan E, Isbaniah F, Atas Asri SD. Preliminary study of Xpert MTB/RIF assay for mycobacterium tuberculosis detection in new presumptive tuberculosis patients with negative sputum acid-fast bacilli. Respirology 2016;21 Suppl 3:197. CENTRAL

Antonenka 2013 {published data only}

Antonenka U, Hofmann-Thiel S, Turaev L, Esenalieva A, Abdulloeva M, Sahalchyk E, et al. Comparison of Xpert MTB/RIF with ProbeTec ET DTB and COBAS TaqMan MTB for direct detection of M. tuberculosis complex in respiratory specimens. BMC Infectious Diseases 2013;13:280. CENTRAL [DOI: 10.1186/1471-2334-13-280]

Ardizzoni 2019 {published data only}

Ardizzoni E, Orikiriza P, Ssuuna C, Nyehangane D, Gumsboga M, Taremwa IM, et al. Evaluation of OMNIgene sputum and ethanol reagent for preservation of sputum prior to Xpert and culture testing in Uganda. Journal of Clinical Microbiology 2019;58(1):e00810-19. CENTRAL

Aricha 2019 {published data only}

Aricha SA, Kingwara L, Mwirigi NW, Chaba L, Kiptai T, Wahogo J, et al. Comparison of GeneXpert and line probe assay for detection of Mycobacterium tuberculosis and rifampicin-mono resistance at the National Tuberculosis Reference Laboratory, Kenya. BMC Infectious Diseases 2019;19(1):852. CENTRAL

Armand 2011 {published data only}

Armand S, Vanhuls P, Delcroix G, Courcol R, Lemaître N. Comparison of the Xpert MTB/RIF test with an IS6110-TaqMan real-time PCR assay for direct detection of Mycobacterium tuberculosis in respiratory and nonrespiratory specimens. Journal of Clinical Microbiology 2011;49(5):1772-6. CENTRAL

Asencio 2013 {published data only}

Asencio Egea MA, Vaquero MH, Carranza Gonzalez R, Castellanos Monedero J, Franco Huerta M, Bravo Nieto JM, et al. Economic impact of the introduction of a technique for early detection of Mycobacterium tuberculosis Complex in clinical samples in a Spanish hospital. Revista Española de Salud Pública 2013;87(4):419-25. CENTRAL

Aston 2016 {published data only}

Aston SJ, Ho A, Jary H, Everett D, Mwandumba H, Heyderman RS, et al. Aetiology and outcome of community-acquired pneumonia in HIV-infected Malawian adults. Topics in Antiviral Medicine 2016;24(E-1):322. CENTRAL

Atashi 2017 {published data only}

Atashi S, Izadi B, Jalilian S, Madani SH, Farahani A, Mohajeri P. Evaluation of GeneXpert MTB/RIF for determination of rifampicin resistance among new tuberculosis cases in west and northwest Iran. New Microbes and New Infections 2017;19:117-20. CENTRAL

Atehortua 2015 {published data only}

Atehortua S, Ramirez F, Echeverri LM, Penata A, Ospina S. Xpert MTB/RIF test performance assay in respiratory samples at real work settings in a developing country. Biomedica 2015;35(1):125-30. CENTRAL

Atuhumuza 2016 {published data only}

Atuhumuza E, Yoon C, Katende J, Asege L, Mwebe S, Andama A, et al. Intensified tuberculosis case-finding among people living with HIV: diagnostic yield of Xpert MTB/RIF, urine lipoarabinomannan and liquid culture. Journal of the International AIDS Society 2016;19:WEAB0202. CENTRAL

Atwine 2015 {published data only}

Atwine D, Nansumba M, Orikiriza P, Riera M, Nackers F, Kamara N, et al. Intra-gastric string test: an effective tool for diagnosing tuberculosis in adults unable to produce sputum. International Journal of Tuberculosis and Lung Disease 2015;19(5):558-64. CENTRAL

Auld 2016 {published data only}

Auld SC, Moore BK, Kyle RP, Eng B, Nong K, Pevzner ES, et al. Mixed impact of Xpert® MTB/RIF on tuberculosis diagnosis in Cambodia. Public Health Action 2016;6(2):129-35. CENTRAL

Aurin 2014 {published data only}

Aurin TH, Munshi SK, Kamal SM, Rahman MM, Hossain MS, Marma T, et al. Molecular approaches for detection of the multi-drug resistant tuberculosis (MDR-TB) in Bangladesh. PLOS ONE 2014;9(6):e99810. CENTRAL

Avashia 2016 {published data only}

Avashia S, Choubey S, Mishra S, Kharate A. To study the usefulness of CBNAAT (cartridge based nuclear acid amplification test) in BAL (bronchoalveolar lavage) samples in the diagnosis of smear-negative/non sputum producing patients with suspected tuberculosis. JEMDS: Journal of Evolution of Medical and Dental Sciences 2016;5(1):55-9. CENTRAL

Ayala 2016 {published data only}

Ayala G, Garay J, Aragon M, Decroo T, Zachariah R. Trends in tuberculosis notification and treatment outcomes in prisons: a country-wide assessment in El Salvador from 2009-2014. Revista Panamericana de Salud Pública 2016;39(1):38-43. CENTRAL

Aydemir 2019 {published data only}

Aydemir O, Karakece E, Koroglu M, Altindis M, Terzi HA. Comparison of the GeneXpert MTB/RIF test and conventional methods in the diagnosis of mycobacterium tuberculosis. Clinical Laboratory 2019;65(1-2):1-6. CENTRAL

Bablishvili 2015 {published data only}

Bablishvili N, Tukvadze N, Avaliani Z, Blumberg HM, Kempker RR. A comparison of the Xpert® MTB/RIF and GenoType® MTBDRplus assays in Georgia. International Journal of Tuberculosis and Lung Disease 2015;19(6):676-8. CENTRAL

Badal‐Faesen 2017 {published data only}

Badal-Faesen S, Firnhaber C, Kendall MA, Wu X, Grinsztejn B, Escada RO, et al. Impact of larger sputum volume on Xpert® MTB/RIF assay detection of Mycobacterium tuberculosis in smear-negative individuals with suspected tuberculosis. Journal of Clinical Medicine 2017;6(8):e78. CENTRAL [DOI: 10.3390/jcm6080078]

Baikunje 2019 {published data only}

Baikunje N, Behera D, Rajwanshi A, Sharma M, Sharma A, Sharma K. Comparative evaluation of loop-mediated isothermal amplification (LAMP) assay, GeneXpert MTB/Rif and multiplex PCR for the diagnosis of tubercular lymphadenitis in HIV-infected patients of North India. Molecular and Cellular Probes 2019;48:101459. CENTRAL

Bajrami 2016 {published data only}

Bajrami R, Mulliqi G, Kurti A, Lila G, Raka L. Comparison of GeneXpert MTB/RIF and conventional methods for the diagnosis of tuberculosis in Kosovo. Journal of Infection in Developing Countries 2016;10(4):418-22. CENTRAL

Balcha 2014 {published data only}

Balcha TT, Winqvist N, Sturegard E, Skogmar S, Reepalu A, Jemal ZH, et al. Detection of lipoarabinomannan in urine for identification of active tuberculosis among HIV-positive adults in Ethiopian health centres. Tropical Medicine & International Health 2014;19(6):734-42. CENTRAL

Banu 2014 {published data only}

Banu S, Rahman SM, Khan MS, Ferdous SS, Ahmed S, Gratz J, et al. Discordance across several methods for drug susceptibility testing of drug-resistant Mycobacterium tuberculosis isolates in a single laboratory. Journal of Clinical Microbiology 2014;52(1):156-63. CENTRAL

Barcellini 2019 {published data only}

Barcellini L, Borroni E, Cimaglia C, Girardi E, Matteelli A, Marchese V, et al. App-based symptoms screening with Xpert MTB/RIF Ultra assay used for active tuberculosis detection in migrants at point of arrivals in Italy: the E-DETECT TB intervention analysis. PLOS ONE 2019;14(7):e0218039. CENTRAL

Barkham 2016 {published data only}

Barkham T, Tang WY. GeneXpert - a state of the art commercial PCR assay, misses a fifth of tuberculosis cases. Annals of the Academy of Medicine Singapore 2016;45 (9 Suppl 1):S53. CENTRAL

Barnard 2012 {published data only}

Barnard M, Gey van Pittius NC, Van Helden PD, Bosman M, Coetzee G, Warren RM. The diagnostic performance of the GenoType MTBDRplus version 2 line probe assay is equivalent to that of the Xpert MTB/RIF assay. Journal of Clinical Microbiology 2012;50(11):3712-6. CENTRAL

Bates 2013 {published data only}

Bates M, O'Grady J, Maeurer M, Tembo J, Chilukutu L, Chabala C, et al. Assessment of the Xpert MTB/RIF assay for diagnosis of tuberculosis with gastric lavage aspirates in children in sub-Saharan Africa: a prospective descriptive study. Lancet Infectious Diseases 2013;13(1):36-42. CENTRAL

Benjamin 2019 {published data only}

Benjamin A, Cavalcante SC, Jamal LF, Arakaki-Sanchez D, de Lima JN, Pilotto JH. Accuracy of Determine TB-LAM Ag to detect TB in HIV infected patients associated with diagnostic methods used in Brazilian public health units. PLOS ONE 2019;14(9):e0221038. CENTRAL

Bhardwaj 2019 {published data only}

Bhardwaj A, Khan S, Kumar A, George L, Mehta A, Radhakrishnan K. Assessing the utility of GeneXpert MTB/Rif assay in a tertiary care centre in Southern India with established microscopy and liquid culture facilities. Journal of the Association of Physicians of India 2019;67(8):31-4. CENTRAL

Biadglegne 2014 {published data only}

Biadglegne F, Rodloff AC, Sack U. A first Insight into high prevalence of undiagnosed smear-negative pulmonary tuberculosis in northern Ethiopian prisons: implications for greater investment and quality control. PLOS ONE 2014;9(9):e106869. CENTRAL

Bilgin 2016 {published data only}

Bilgin K, Yanik K, Karadag A, Odabasi H, Tas H, Gunaydin M. Comparison of a real-time polymerase chain reaction-based system and Erlich-Ziehl-Neelsen method with culture in the identification of Mycobacterium tuberculosis. Turkish Journal of Medical Sciences 2016;46(1):203-6. CENTRAL

Bimba 2019 {published data only}

Bimba JS, Lawson L, Kontogianni K, Edwards T, Ekpenyong BE, Dodd J. PrimeStore MTM and OMNIgene sputum for the preservation of sputum for Xpert MTB/RIF testing in Nigeria. Journal of Clinical Medicine 2019;8(12):2146. CENTRAL

Bisognin 2018 {published data only}

Bisognin F, Lombardi G, Lombardo D, Re MC, Dal Monte P. Improvement of Mycobacterium tuberculosis detection by Xpert MTB/RIF Ultra: a head-to-head comparison on Xpert-negative samples. PLOS ONE 2018;13(8):e0201934. CENTRAL

Bjerrum 2015 {published data only}

Bjerrum S, Kenu E, Lartey M, Newman MJ, Addo KK, Andersen AB, et al. Diagnostic accuracy of the rapid urine lipoarabinomannan test for pulmonary tuberculosis among HIV-infected adults in Ghana-findings from the DETECT HIV-TB study. BMC Infectious Diseases 2015;15:407. CENTRAL

Boakye‐Appiah 2016 {published data only}

Boakye-Appiah JK, Steinmetz AR, Pupulampu P, Ofori-Yirenkyi S, Tetteh I, Frimpong M, et al. High prevalence of multidrug-resistant tuberculosis among patients with rifampicin resistance using GeneXpert Mycobacterium tuberculosis/rifampicin in Ghana. International Journal of Mycobacteriology 2016;5(2):226-30. CENTRAL

Bojang 2016 {published data only}

Bojang AL, Mendy FS, Tientcheu LD, Otu J, Antonio M, Kampmann B, et al. Comparison of TB-LAMP, GeneXpert MTB/RIF and culture for diagnosis of pulmonary tuberculosis in The Gambia. Journal of Infection 2016;72(3):332-7. CENTRAL

Bonnet 2017 {published data only}

Bonnet M, San KC, Pho Y, Sok C, Dousset JP, Brant W, et al. Nontuberculous mycobacteria infections at a provincial reference hospital, Cambodia. Emerging Infectious Diseases 2017;23(7):1139-47. CENTRAL

Borodulina 2019 {published data only}

Borodulina EA, Borodulin BE, In'kova AT, Vdoushkina ES, Povalyayeva LV. New possibilities to diagnose pulmonary tuberculosis at a pulmonology inpatient department. Pulmonologiya 2019;29(3):321-6. CENTRAL

Boum 2016 {published data only}

Boum Y 2nd, Kim S, Orikiriza P, Acuña-Villaorduña C, Vinhas S, Bonnet M, et al. Diagnostic accuracy of the small membrane filtration method for diagnosis of pulmonary tuberculosis in a high-HIV-prevalence setting. Journal of Clinical Microbiology 2016;54(6):1520-7. CENTRAL

Bowles 2011 {published data only}

Bowles EC, Freyée B, Van Ingen J, Mulder B, Boeree MJ, Van Soolingen D. Xpert MTB/RIF®, a novel automated polymerase chain reaction-based tool for the diagnosis of tuberculosis. International Journal of Tuberculosis and Lung Disease 2011;15(7):988-9. CENTRAL

Bunsow 2014 {published data only}

Bunsow E, Ruiz-Serrano MJ, Lopez Roa P, Kestler M, Viedma DG, Bouza E. Evaluation of GeneXpert MTB/RIF for the detection of Mycobacterium tuberculosis and resistance to rifampin in clinical specimens. Journal of Infection 2014;68(4):338-43. CENTRAL

Byashalira 2019 {published data only}

Byashalira K, Mbelele P, Semvua H, Chilongola J, Semvua S, Liyoyo A, et al. Clinical outcomes of new algorithm for diagnosis and treatment of tuberculosis sepsis in HIV patients. International Journal of Mycobacteriology 2019;8(4):313-9. CENTRAL

Capocci 2016 {published data only}

Capocci S, Sewell J, Smith C, Cropley I, Bhagani S, Morris S, et al. Testing for TB in a contemporary UK HIV clinic - is it really worth it? HIV Medicine 2016;17(Suppl 1):38-9. CENTRAL

Causse 2011 {published data only}

Causse M, Ruiz P, Gutiérrez-Aroca JB, Casal M. Comparison of two molecular methods for rapid diagnosis of extrapulmonary tuberculosis. Journal of Clinical Microbiology 2011;49(8):3065-7. CENTRAL

Cavanaugh 2016 {published data only}

Cavanaugh JS, Modi S, Musau S, McCarthy K, Alexander H, Burmen B, et al. Comparative yield of different diagnostic tests for tuberculosis among people living with HIV in western Kenya. PLOS ONE 2016;11(3):e0152364. CENTRAL

Cayci 2017 {published data only}

Cayci YT, Bilgin K, Coban AY, Birinci A, Durupinar B. An evaluation of false-positive rifampicin resistance on the Xpert MTB/RIF. Memórias do Instituto Oswaldo Cruz 2017;112(11):756-9. CENTRAL

Celik 2015 {published data only}

Celik C, Gozel MG, Bakici MZ, Berk S, Ozsahin SL, Gulturk E. Applicability of Xpert MTB/RIF assay for routine diagnosis of tuberculosis: a four-year single-center experience. Turkish Journal of Medical Sciences 2015;45(6):1329-34. CENTRAL

Chakraborty 2019 {published data only}

Chakraborty A, Ramaswamy S, Shivananjiah AJ, Puttaswamy RB, Chikkavenkatappa N. The role of GeneXpert in the diagnosis of tubercular pleural effusion in India. Advances in Respiratory Medicine 2019;87(5):276-80. CENTRAL

Chhajed 2019 {published data only}

Chhajed PN, Vaidya PJ, Mandovra NP, Chavhan VB, Lele TT, Nair R, et al. EBUS-TBNA in the rapid microbiological diagnosis of drug-resistant mediastinal tuberculous lymphadenopathy. European Respiratory Journal Open Research 2019;5(4):00008-2019. CENTRAL

Chishty 2016 {published data only}

Chishty S, Farooqi J, Shafqat Y, Shafiq S, Jabeen K, Hasan R. Performance of Xpert MTB/RIF assay from fluorescent acid fast stained slides. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA2781. CENTRAL

Ciftçi 2011 {published data only}

Ciftçi IH, Aslan MH, Aşik G. Evaluation of Xpert MTB/RIF results for the detection of Mycobacterium tuberculosis in clinical samples. Mikrobiyoloji bülteni 2011;45(1):43-7. CENTRAL

Clouse 2012 {published data only}

Clouse K, Page-Shipp L, Dansey H, Moatlhodi B, Scott L, Bassett J, et al. Implementation of Xpert MTB/RIF for routine point-of-care diagnosis of tuberculosis at the primary care level. South African Medical Journal 2012;102(10):805-7. CENTRAL

Cross 2014 {published data only}

Cross GB, Coles K, Nikpour M, Moore OA, Denholm J, McBryde ES, et al. TB incidence and characteristics in the remote gulf province of Papua New Guinea: a prospective study. BMC Infectious Diseases 2014;14:93. CENTRAL

Cross 2015 {published data only}

Cross LJ, Anscombe C, McHugh TD, Abubakar I, Shorten RJ, Thorne N, et al. A rapid and sensitive diagnostic screening assay for detection of mycobacteria including Mycobacterium tuberculosis directly from sputum without extraction. International Journal of Bacteriology 2015;2015:593745. CENTRAL

Dagnra 2015 {published data only}

Dagnra AY, Mlaga KD, Adjoh K, Kadanga E, Disse K, Adekambi T. Prevalence of multidrug-resistant tuberculosis cases among HIV-positive and HIV-negative patients eligible for retreatment regimen in Togo using GeneXpert MTB/RIF. New Microbes and New Infections 2015;8:24-7. CENTRAL

Dahale 2019 {published data only}

Dahale AS, Puri AS, Kumar A, Dalal A, Agarwal A, Sachdeva S. Tissue Xpert(R) MTB/RIF assay in peritoneal tuberculosis: to be (done) or not to be (done). Cureus 2019;11(6):e5009. CENTRAL

Daum 2015 {published data only}

Daum LT, Peters RP, Fourie PB, Jonkman K, Worthy SA, Rodriguez JD, et al. Molecular detection of Mycobacterium tuberculosis from sputum transported in PrimeStore® from rural settings. International Journal of Tuberculosis and Lung Disease 2015;19(5):552-7. CENTRAL

Deggim 2013 {published data only}

Deggim V, Somoskovi A, Voit A, Bottger EC, Bloemberg GV. Integrating the Xpert MTB/RIF assay into a diagnostic workflow for rapid detection of Mycobacterium tuberculosis in a low-prevalence area. Journal of Clinical Microbiology 2013;51(7):2396-9. CENTRAL

Dierberg 2016 {published data only}

Dierberg KL, Dorjee K, Salvo F, Cronin WA, Boddy J, Cirillo D, et al. Improved detection of tuberculosis and multidrug-resistant tuberculosis among Tibetan refugees, India. Emerging Infectious Diseases 2016;22(3):463-8. CENTRAL

Dorjee 2012 {published data only}

Dorjee K, Salvo F, Dierberg KL. Xpert® MTB/RIF diagnosed disseminated smear-negative MDR-TB in a sub-district hospital in India. International Journal of Tuberculosis and Lung Disease 2012;16(11):1560-1. CENTRAL

Dorman 2012 {published data only}

Dorman SE, Chihota VN, Lewis JJ, Shah M, Clark D, Grant AD, et al. Performance characteristics of the Cepheid Xpert MTB/RIF test in a tuberculosis prevalence survey. PLOS ONE 2012;7(8):e43307. CENTRAL

Dowdy 2011 {published data only}

Dowdy DW, Cattamanchi A, Steingart KR, Pai M. Is scale-up worth it? Challenges in economic analysis of diagnostic tests for tuberculosis. PLOS Medicine 2011;8(7):e1001063. CENTRAL

Eldin 2019 {published data only}

Eldin MT, Hamid HA, Elnady M. Evaluation of GeneXpert as a new diagnostic tool for detection of pulmonary tuberculosis. Egyptian Journal of Chest Diseases and Tuberculosis 2019;68(3):270-3. CENTRAL

Elzein 2019 {published data only}

Elzein FE, Alsherbeeni N, Mursi M, Algoblan SF, Abuzaid AA, Albarrak AM. Isolation and deisolation of patients admitted with presumptive pulmonary tuberculosis. Can it be shortened? Saudi Medical Journal 2019;40(10):1008-12. CENTRAL

Fantahun 2019 {published data only}

Fantahun M, Kebede A, Yenew B, Gemechu T, Mamuye Y, Tadesse M, et al. Diagnostic accuracy of Xpert MTB/RIF assay and non-molecular methods for the diagnosis of tuberculosis lymphadenitis. PLOS ONE 2019;14(9):e0222402. CENTRAL

Feasey 2013 {published data only}

Feasey NA, Banada PP, Howson W, Sloan DJ, Mdolo A, Boehme C, et al. Evaluation of Xpert MTB/RIF for detection of tuberculosis from blood samples of HIV-infected adults confirms Mycobacterium tuberculosis bacteremia as an indicator of poor prognosis. Journal of Clinical Microbiology 2013;51(7):2311-6. CENTRAL

Fernandez 2017 {published data only}

Fernandez Sanchez M, Lasso JI, Canas A, Morantes Ariza C, Cortes G, Sanchez Duran L, et al. Evaluation of the operating characteristics of GeneXpert MTB/RIF at a national reference center: Hospital Universitario San Ignacio, Bogota, Colombia. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society International Conference 2017;195:A2084. CENTRAL

FIND 2011 {published data only}

Foundation for Innovative Diagnostics. Performance of Xpert MTB/RIF Version G4 assay, Version and date: 1.0/30 Nov 2011, Project: 7210. www.stoptb.org/wg/gli/assets/documents/map/findg4cartridge.pdf (accessed 8 May 2019). CENTRAL

Fong 2017 {published data only}

Fong A, Wei C, Chang AH, Kerndt PR, Shulman IA, Butler-Wu S. Evaluation of the Xpert MTB/RIF assay for the detection of tuberculosis in patients being evaluated for tuberculosis in a large public hospital in the United States. Laboratory Investigation 2017;97 Suppl 1:390A. CENTRAL

Friedrich 2011 {published data only}

Friedrich SO, Von Groote-Bidlingmaier F, Diacon AH. Xpert MTB/RIF assay for the diagnosis of pleural tuberculosis. Journal of Clinical Microbiology 2011;49(12):4341-2. CENTRAL

Gama de Andrade 2017 {published data only}

Gama de Andrade TL, Gouget Ferreira Silvano RG, Pombo March MF, Coelho Soares EC, Couto Sant'anna C, Baroni Aurilio R. The Xpert MTB-RIF to diagnose tuberculosis in adolescents from Rio de Janeiro, Brazil. Pediatric Pulmonology 2017;52(Suppl 46):S164-5. CENTRAL

Garcia‐Basteiro 2019 {published data only}

Garcia-Basteiro AL, Hurtado JC, Castillo P, Fernandes F, Navarro M, Lovane L, et al. Unmasking the hidden tuberculosis mortality burden in a large postmortem study in Maputo Central Hospital, Mozambique. European Respiratory Journal 2019;54(3):1900312. CENTRAL

Gati 2018 {published data only}

Gati S, Chetty R, Wilson D, Achkar JM. Utilization and clinical value of diagnostic modalities for tuberculosis in a high HIV prevalence setting. American Journal of Tropical Medicine and Hygiene 2018;99(2):317-22. CENTRAL

Gelalcha 2017 {published data only}

Gelalcha AG, Kebede A, Mamo H. Light-emitting diode fluorescent microscopy and Xpert MTB/RIF(R) assay for diagnosis of pulmonary tuberculosis among patients attending Ambo hospital, west-central Ethiopia. BMC Infectious Diseases 2017;17(1):613. CENTRAL

Gounder 2014 {published data only}

Gounder A, Gounder S, Reid SA. Evaluation of the implementation of the Xpert(R) MTB/RIF assay in Fiji. Public Health Action 2014;4(3):179-83. CENTRAL

Griesel 2016 {published data only}

Griesel R, Stewart A, Van Der Plas H, Sikhondze W, Rangaka M, Maartens G, et al. A clinical prediction rule for the diagnosis of tuberculosis in seriously ill adults. Topics in Antiviral Medicine 2016;24 (E-1):309-10. CENTRAL

Griesel 2017 {published data only}

Griesel R, Stewart A, Van der Plas H, Sikhondze W, Rangaka MX, Nicol MP, et al. Optimizing tuberculosis diagnosis in HIV-infected inpatients meeting the criteria of seriously ill in the WHO algorithm. Clinical Infectious Diseases 2017;66(9):1419-26. CENTRAL

Guenaoui 2016 {published data only}

Guenaoui K, Harir N, Ouardi A, Zeggai S, Sellam F, Bekri F, et al. Use of GeneXpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases. Annals of Translational Medicine 2016;4(9):168. CENTRAL

Gupta 2014 {published data only}

Gupta RK, Lawn SD, Booth H, Morris-Jones S. What is the role for Xpert® MTB/RIF in high-resource settings? Experience from a central London hospital. International Journal of Tuberculosis and Lung Disease 2014;18(11):1323-6. CENTRAL

Gurbanova 2016 {published data only}

Gurbanova E, Mehdiyev R, Blondal K, Tahirli R, Mirzayev F, Hillemann D, et al. Interpretation of indeterminate RIF-susceptibility results obtained by rapid molecular diagnostics test. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA1907. CENTRAL

Gurbanova 2017 {published data only}

Gurbanova E, Mehdiyev R, Blondal K, Tahirli R, Mirzayev F, Hillemann D, et al. Mitigation of discordant rifampicin-susceptibility results obtained by Xpert Mycobacterium tuberculosis/Rifampicin and Mycobacterium Growth Indicator Tube. Microbial Drug Resistance 2017;23(8):1045-52. CENTRAL

Gursoy 2016 {published data only}

Gursoy NC, Yakupogullari Y, Tekerekoglu MS, Otlu B. Evaluation of the diagnostic performance of Xpert MTB/RIF test for the detection of Mycobacterium tuberculosis and rifampin resistance in clinical samples. Mikrobiyoloji bülteni 2016;50(2):196-204. CENTRAL

Habeenzu 2017 {published data only}

Habeenzu C, Nakajima C, Solo E, Bwalya P, Kajino K, Miller M, et al. Evaluation of in-house loop-mediated isothermal amplification for tuberculosis diagnosis compared with Xpert MTB/RIF. Journal of Infection in Developing Countries 2017;11(6):440-4. CENTRAL

Hai 2019 {published data only}

Hai HT, Vinh DN, Thu DDA, Hanh NT, Phu NH, Srinivasan V, et al. Comparison of the Mycobacterium tuberculosis molecular bacterial load assay, microscopy and GeneXpert versus liquid culture for viable bacterial load quantification before and after starting pulmonary tuberculosis treatment. Tuberculosis (Edinb) 2019;119:101864. CENTRAL

Hanifa 2016 {published data only}

Hanifa Y, Fielding KL, Chihota VN, Adonis L, Charalambous S, Karstaedt A, et al. Diagnostic accuracy of lateral flow urine LAM assay for TB screening of adults with advanced immunosuppression attending routine HIV care in South Africa. PLOS ONE 2016;11(6):e0156866. CENTRAL

Heidebrecht 2016 {published data only}

Heidebrecht CL, Podewils LJ, Pym AS, Cohen T, Mthiyane T, Wilson D. Assessing the utility of Xpert® MTB/RIF as a screening tool for patients admitted to medical wards in South Africa. Scientific Reports 2016;6:19391. CENTRAL

Hillemann 2011 {published data only}

Hillemann D, Rüsch-Gerdes S, Boehme C, Richter E. Rapid molecular detection of extrapulmonary tuberculosis by the automated GeneXpert MTB/RIF system. Journal of Clinical Microbiology 2011;49(4):1202-5. CENTRAL

Hiza 2017 {published data only}

Hiza H, Doulla B, Sasamalo M, Hella J, Kamwela L, Mhimbira F, et al. Preservation of sputum samples with cetylpyridinium chloride (CPC) for tuberculosis cultures and Xpert MTB/RIF in a low-income country. BMC Infectious Diseases 2017;17(1):542. CENTRAL

Ho 2016 {published data only}

Ho J, Nguyen PT, Nguyen TA, Tran KH, Nguyen S, Nguyen NV, et al. Reassessment of the positive predictive value and specificity of Xpert MTB/RIF: a diagnostic accuracy study in the context of community-wide screening for tuberculosis. Lancet Infectious Diseases 2016;16(9):1045-51. CENTRAL

Hodille 2019 {published data only}

Hodille E, Maisson A, Charlet L, Bauduin C, Genestet C, Fredenucci I, et al. Evaluation of Xpert MTB/RIF Ultra performance for pulmonary tuberculosis diagnosis on smear-negative respiratory samples in a French centre. European Journal of Clinical Microbiology & Infectious Diseases 2019;38(3):601-5. CENTRAL

Horo 2017 {published data only}

Horo K, N'Guessan R, Koffi MO, Kouame-N'Takpe N, Kone A, Samake K, et al. Use of the Xpert® MTB/RIF test in routine screening of new cases of pulmonary tuberculosis in an endemic area. Revue des Maladies Respiratoires 2017;34(7):749-57. CENTRAL

Hu 2014 {published data only}

Hu P, Bai L, Liu F, Ou X, Zhang Z, Yi S, et al. Evaluation of the Xpert MTB/RIF assay for diagnosis of tuberculosis and rifampin resistance in county-level laboratories in Hunan province, China. Chinese Medical Journal 2014;127(21):3744-50. CENTRAL

Huang 2018 {published data only}

Huang H, Zhang Y, Li S, Wang J, Chen J, Pan Z, et al. Rifampicin resistance and multidrug-resistant tuberculosis detection using Xpert MTB/RIF in Wuhan, China: a retrospective study. Microbial Drug Resistance 2018;24(5):675-9. CENTRAL [DOI: 10.1089/mdr.2017.0114]

Huerga 2017 {published data only}

Huerga H, Ferlazzo G, Bevilacqua P, Kirubi B, Ardizzoni E, Wanjala S, et al. Incremental yield of including determine-TB LAM assay in diagnostic algorithms for hospitalized and ambulatory HIV-positive patients in Kenya. PLOS ONE 2017;12(1):e0170976. CENTRAL [DOI: 10.1371/journal.pone.0170976]

Ioannidis 2010 {published data only}

Ioannidis P, Papaventsis D, Nikolaou S, Karabela S, Konstantinidou E, Marinou I, et al. Tuberculosis resistance detection rate to the two main anti-TB drugs, isoniazid and rifampicin, using molecular techniques: experience of the Hellenic National Reference Center for Mycobacteria. Acta Microbiologica Hellenica 2010;55:175-82. CENTRAL

Ioannidis 2011 {published data only}

Ioannidis P, Papaventsis D, Karabela S, Nikolaou S, Panagi M, Raftopoulou E, et al. Cepheid GeneXpert MTB/RIF assay for Mycobacterium tuberculosis detection and rifampin resistance identification in patients with substantial clinical indications of tuberculosis and smear-negative microscopy results. Journal of Clinical Microbiology 2011;49(8):3068-70. CENTRAL

Iram 2015 {published data only}

Iram S, Zeenat A, Hussain S, Wasim Yusuf N, Aslam M. Rapid diagnosis of tuberculosis using Xpert MTB/RIF assay - report from a developing country. Pakistan Journal of Medical Sciences 2015;31(1):105-10. CENTRAL

Jafari 2013 {published data only}

Jafari C, Ernst M, Kalsdorf B, Lange C. Comparison of molecular and immunological methods for the rapid diagnosis of smear-negative tuberculosis. International Journal of Tuberculosis and Lung Disease 2013;17(11):1459-65. CENTRAL

Jin 2019 {published data only}

Jin Y, Wang HQ, Fan JG, Pang J, Zhang PY, Li T. Evaluation of GeneXpert MTB/RIF and BACTEC-MGIT 960 for the detection of tuberculosis among pneumoconiosis-associated tuberculosis patients. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi 2019;37(9):690-3. CENTRAL

Jing 2017 {published data only}

Jing H, Lu ZM, Deng YF, Gao DC, Li L, Graviss EA, et al. Evaluation of Xpert MTB/RIF in detection of pulmonary and extrapulmonary tuberculosis cases in China. International Journal of Clinical and Experimental Pathology 2017;10(4):4847-51. CENTRAL

Jipa 2016 {published data only}

Jipa R, Manea E, Cernat R, Iringo K, Vat AA, Arbune M, et al. Drug-resistant tuberculosis in HIV infected patients. BMC Infectious Diseases 2016;16(4):A107. CENTRAL

Jones‐Lopez 2014 {published data only}

Jones-Lopez E, Manabe YC, Palaci M, Kayiza C, Armstrong D, Nakiyingi L, et al. Prospective cross-sectional evaluation of the small membrane filtration method for diagnosis of pulmonary tuberculosis. Journal of Clinical Microbiology 2014;52(7):2513-20. CENTRAL

Kang 2016 {published data only}

Kang JY, Hyung Woo K, Sanghoon J, Jaeha L, Shinyoung K, Chan Kwon P, et al. Clinical features of discordant result between molecular and phenotypic susceptibility tests in tuberculosis patients. Respirology 2016;21(Suppl 3):200. CENTRAL

Kaur 2016 {published data only}

Kaur R, Kachroo K, Sharma JK, Vatturi SM, Dang A. Diagnostic accuracy of Xpert test in tuberculosis detection: a systematic review and meta-analysis. Journal of Global Infectious Diseases 2016;8(1):32-40. CENTRAL

Kayigire 2013 {published data only}

Kayigire XA, Friedrich SO, Venter A, Dawson R, Gillespie SH, Boeree MJ, et al. Direct comparison of Xpert MTB/RIF assay with liquid and solid mycobacterial culture for quantification of early bactericidal activity. Journal of Clinical Microbiology 2013;51(6):1894-8. CENTRAL

Kazemian 2019 {published data only}

Kazemian H, Kardan-Yamchi J, Bahador A, Khonsari S, Nasehi M, Hamzehloo G, et al. Efficacy of line probe assay in detection of drug-resistant pulmonary tuberculosis in comparison with GeneXpert and phenotypic methods in Iran and genetic analysis of isolates by MIRU-VNTR. Infection and Drug Resistance 2019;12:3585-93. CENTRAL

Kelly‐Cirino 2017 {published data only}

Kelly-Cirino CD, Musisi E, Byanyima P, Kaswabuli S, Andama A, Sessolo A, et al. Investigation of OMNIgene.SPUTUM performance in delayed tuberculosis testing by smear, culture, and Xpert MTB/RIF assays in Uganda. Journal of Epidemiology and Global Health 2017;7(2):103-9. CENTRAL

Kendall 2019 {published data only}

Kendall EA, Kamoga C, Kitonsa PJ, Nalutaaya A, Salvatore PP, Robsky K, et al. Empiric treatment of pulmonary TB in the Xpert era: correspondence of sputum culture, Xpert MTB/RIF, and clinical diagnoses. PLOS ONE 2019;14(7):e0220251. CENTRAL

Kerkhoff 2013 {published data only}

Kerkhoff AD, Wood R, Lowe DM, Vogt M, Lawn SD. Blood neutrophil counts in HIV-infected patients with pulmonary tuberculosis: association with sputum mycobacterial load. PLOS ONE 2013;8(7):e67956. CENTRAL

Kerkhoff 2014 {published data only}

Kerkhoff AD, Wood R, Vogt M, Lawn SD. Predictive value of anemia for tuberculosis in HIV-infected patients in Sub-Saharan Africa: an indication for routine microbiological investigation using new rapid assays. Journal of Acquired Immune Deficiency Syndromes 2014;66(1):33-40. CENTRAL

Khadka 2019 {published data only}

Khadka P, Thapaliya J, Basnet RB, Ghimire GR, Amatya J, Rijal BP. Diagnosis of tuberculosis from smear-negative presumptive TB cases using Xpert MTB/Rif assay: a cross-sectional study from Nepal. BMC Infectious Diseases 2019;19(1):1090. CENTRAL

Khalil 2015 {published data only}

Khalil KF, Butt T. Diagnostic yield of bronchoalveolar lavage gene Xpert in smear-negative and sputum-scarce pulmonary tuberculosis. Journal of the College of Physicians and Surgeons Pakistan 2015;25(2):115-8. CENTRAL

Khan 2016 {published data only}

Khan SU, Rahman H, Ayaz S, Qasim M, Jabbar A, Khurshid M, et al. GeneXpert assay for rapid detection of Mycobacterium tuberculosis complex in respiratory specimens from a high TB endemic area of Pakistan. Microbial Pathogenesis 2016;95:82-5. CENTRAL

Kim 2012 {published data only}

Kim SY, Kim H, Kim SY, Ra EK, Joo SI, Shin S, et al. The Xpert® MTB/RIF assay evaluation in South Korea, a country with an intermediate tuberculosis burden. International Journal of Tuberculosis and Lung Disease 2012;16(11):1471-6. CENTRAL

Kim CH 2014 {published data only}

Kim CH, Woo H, Hyun IG, Kim C, Choi JH, Jang SH, et al. A comparison between the efficiency of the Xpert MTB/RIF assay and nested PCR in identifying Mycobacterium tuberculosis during routine clinical practice. Journal of Thoracic Disease 2014;6(6):625-31. CENTRAL

Kim CH 2015 {published data only}

Kim CH, Hyun IG, Hwang YI, Kim DG, Lee CY, Lee MG, et al. Identification of Mycobacterium tuberculosis and rifampin resistance in clinical specimens using the XpertMTB/RIF assay. Annals of Clinical and Laboratory Science 2015;45(1):32-8. CENTRAL

Kim MJ 2015 {published data only}

Kim MJ, Nam YS, Cho SY, Park TS, Lee HJ. Comparison of the Xpert MTB/RIF Assay and real-time PCR for the detection of Mycobacterium tuberculosis. Annals of Clinical and Laboratory Science 2015;45(3):327-32. CENTRAL

Kim YW 2015 {published data only}

Kim YW, Seong MW, Kim TS, Yoo CG, Han SK, Yim JJ. Evaluation of Xpert® MTB/RIF assay: diagnosis and treatment outcomes in rifampicin-resistant tuberculosis. International Journal of Tuberculosis and Lung Disease 2015;19(10):1216-21. CENTRAL

Kolia‐Diafouka 2019 {published data only}

Kolia-Diafouka P, Carrere-Kremer S, Lounnas M, Bourdin A, Kremer L, Van de Perre P, et al. Detection of Mycobacterium tuberculosis in paucibacillary sputum: performances of the Xpert MTB/RIF ultra compared to the Xpert MTB/RIF, and IS6110 PCR. Diagnostic Microbiology and Infectious Disease 2019;94(4):365-70. CENTRAL

Lange 2017 {published data only}

Lange B, Khan P, Kalmambetova G, Al-Darraji HA, Alland D, Antonenka U, et al. Diagnostic accuracy of the Xpert® MTB/RIF cycle threshold level to predict smear positivity: a meta-analysis. International Journal of Tuberculosis and Lung Disease 2017;21(5):493-502. CENTRAL

Laskar 2017 {published data only}

Laskar N, Hossain MA, Nasreen SA, Kamal SM, Roy S, Nahar F, et al. Comparative yielding of BACTEC MGIT 960 and GeneXpert MTB/RIF assay for rapid diagnosis of drug resistance tuberculosis from sputum specimen. Mymensingh Medical Journal 2017;26(4):885-91. CENTRAL

Lawn 2012a {published data only}

Lawn SD, Kerkhoff AD, Vogt M, Ghebrekristos Y, Whitelaw A, Wood R. Characteristics and early outcomes of patients with Xpert MTB/RIF-negative pulmonary tuberculosis diagnosed during screening before antiretroviral therapy. Clinical Infectious Diseases 2012;54(8):1071-9. CENTRAL

Lawn 2012b {published data only}

Lawn SD, Kerkhoff AD, Vogt M, Wood R. High diagnostic yield of tuberculosis from screening urine samples from HIV-infected patients with advanced immunodeficiency using the Xpert MTB/RIF assay. Journal of Acquired Immune Deficiency Syndromes 2012;60(3):289-94. CENTRAL

Lawn 2012c {published data only}

Lawn SD, Kerkhoff AD, Vogt M, Wood R. Clinical significance of lipoarabinomannan detection in urine using a low-cost point-of-care diagnostic assay for HIV-associated tuberculosis. AIDS 2012;26(13):1635-43. CENTRAL

Lawn 2013 {published data only}

Lawn SD, Kerkhoff AD, Vogt M, Wood R. HIV-associated tuberculosis: relationship between disease severity and the sensitivity of new sputum-based and urine-based diagnostic assays. BMC Medicine 2013;11:231. CENTRAL

Lawn 2015 {published data only}

Lawn SD, Kerkhoff AD, Burton R, Schutz C, Van Wyk G, Vogt M, et al. Rapid microbiological screening for tuberculosis in HIV-positive patients on the first day of acute hospital admission by systematic testing of urine samples using Xpert MTB/RIF: a prospective cohort in South Africa. BMC Medicine 2015;13:192. CENTRAL

Lawn 2017 {published data only}

Lawn SD, Kerkhoff AD, Burton R, Schutz C, Boulle A, Vogt M, et al. Diagnostic accuracy, incremental yield and prognostic value of Determine TB-LAM for routine diagnostic testing for tuberculosis in HIV-infected patients requiring acute hospital admission in South Africa: a prospective cohort. BMC Medicine 2017;15(1):67. CENTRAL

Lebina 2016 {published data only}

Lebina L, Fuller N, Osoba T, Scott L, Motlhaoleng K, Rakgokong M, et al. The use of Xpert MTB/RIF for active case finding among TB contacts in North West Province, South Africa. Tuberculosis Research and Treatment 2016;2016:4282313. CENTRAL

Lessells 2017 {published data only}

Lessells RJ, Cooke GS, McGrath N, Nicol MP, Newell ML, Godfrey-Faussett P. Impact of point-of-care Xpert MTB/RIF on tuberculosis treatment initiation. A cluster-randomized trial. American Journal of Respiratory and Critical Care Medicine 2017;196(7):901-10. CENTRAL

Li 2016 {published data only}

Li Q, Bao XD, Liu Y, Ou XC, Pang Y, Zhao YL. Comparison of two molecular assays for detecting smear negative pulmonary tuberculosis. Biomedical and Environmental Sciences 2016;29(4):248-53. CENTRAL

Li 2017 {published data only}

Li S, Liu B, Peng M, Chen M, Yin W, Tang H, et al. Diagnostic accuracy of Xpert MTB/RIF for tuberculosis detection in different regions with different endemic burden: a systematic review and meta-analysis. PLOS ONE 2017;12(7):e0180725. CENTRAL

Li 2020 {published data only}

Li X, Du W, Wang Y, Liu Z, Li K, Chen H, et al. Rapid diagnosis of tuberculosis meningitis by detecting Mycobacterium tuberculosis cell-free DNA in cerebrospinal fluid. American Journal of Clinical Pathology 2020;153(1):126-30. CENTRAL

Ligthelm 2011 {published data only}

Ligthelm LJ, Nicol MP, Hoek KG, Jacobson R, Van Helden PD, Marais BJ, et al. Xpert MTB/RIF for rapid diagnosis of tuberculous lymphadenitis from fine-needle-aspiration biopsy specimens. Journal of Clinical Microbiology 2011;49(11):3967-70. CENTRAL

Lombardi 2017 {published data only}

Lombardi G, Di Gregori V, Girometti N, Tadolini M, Bisognin F, Dal Monte P. Diagnosis of smear-negative tuberculosis is greatly improved by Xpert MTB/RIF. PLOS ONE 2017;12(4):e0176186. CENTRAL

Luetkemeyer 2016 {published data only}

Luetkemeyer AF, Firnhaber C, Kendall MA, Wu X, Mazurek GH, Benator DA, et al. Evaluation of Xpert MTB/RIFversus AFB smear and culture to identify pulmonary tuberculosis in patients with suspected tuberculosis from low and higher prevalence settings. Clinical InfectiousDiseases 2016;62(9):1081–8. CENTRAL

Mafort 2017 {published data only}

Mafort TT, Rodrigues LS, Santos A, Reis LVT, Faria LF, Brito GMX, et al. Bronchoalveolar lavage GeneXpert MTB/RIF performance in smear-negative pulmonary tuberculosis - a tertiary care experience in Rio De Janeiro, Brazil. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society International Conference 2017;195:A2085. CENTRAL

Malbruny 2011 {published data only}

Malbruny B, Le Marrec G, Courageux K, Leclercq R, Cattoir V. Rapid and efficient detection of Mycobacterium tuberculosis in respiratory and non-respiratory samples. International Journal of Tuberculosis and Lung Disease 2011;15(4):553-5. CENTRAL

Marlowe 2011 {published data only}

Marlowe EM, Novak-Weekley SM, Cumpio J, Sharp SE, Momeny MA, Babst A, et al. Evaluation of the Cepheid Xpert MTB/RIF assay for direct detection of Mycobacterium tuberculosis complex in respiratory specimens. Journal of Clinical Microbiology 2011;49(4):1621-3. CENTRAL

Matabane 2015 {published data only}

Matabane MM, Ismail F, Strydom KA, Onwuegbuna O, Omar SV, Ismail N. Performance evaluation of three commercial molecular assays for the detection of Mycobacterium tuberculosis from clinical specimens in a high TB-HIV-burden setting. BMC Infectious Diseases 2015;15:508. CENTRAL

Mave 2017 {published data only}

Mave V, Nimkar S, Prasad H, Kadam D, Meshram S, Lokhande R, et al. Tuberculosis screening among persons with diabetes mellitus in Pune, India. BMC Infectious Diseases 2017;17(1):388. CENTRAL

Maynard‐Smith 2014 {published data only}

Maynard-Smith L, Larke N, Peters JA, Lawn SD. Diagnostic accuracy of the Xpert MTB/RIF assay for extrapulmonary and pulmonary tuberculosis when testing non-respiratory samples: a systematic review. BMC Infectious Diseases 2014;14:709. CENTRAL

Mechal 2019 {published data only}

Mechal Y, Benaissa E, El Mrimar N, Benlahlou Y, Bssaibis F, Zegmout A, et al. Evaluation of GeneXpert MTB/RIF system performances in the diagnosis of extrapulmonary tuberculosis. BMC Infectious Diseases 2019;19(1):1069. CENTRAL

Miller 2011 {published data only}

Miller MB, Popowitch EB, Backlund MG, Ager EP. Performance of Xpert MTB/RIF RUO Assay and IS6110 Real-Time PCR for Mycobacterium tuberculosis detection in clinical samples. Journal of Clinical Microbiology 2011;49(10):3458-62. CENTRAL

Miotto 2012 {published data only}

Miotto P, Bigoni S, Migliori GB, Matteelli A, Cirillo DM. Early tuberculosis treatment monitoring by Xpert(R) MTB/RIF. European Respiratory Journal2012;39(5):1269-71. CENTRAL

Mntonintshi 2017 {published data only}

Mntonintshi M, O'Mahony D, Mabunda S, Namugenyi KA. Undiagnosed tuberculosis in patients with HIV infection who present with severe anaemia at a district hospital. African Journal of Primary Health Care and Family Medicine 2017;9(1):e1-6. CENTRAL

Modi 2016 {published data only}

Modi S, Cavanaugh JS, Shiraishi RW, Alexander HL, McCarthy KD, Burmen B, et al. Performance of clinical screening algorithms for tuberculosis intensified case finding among people living with HIV in Western Kenya. PLOS ONE2016;11(12):e0167685. CENTRAL [DOI: 10.1371/journal.pone.0167685]

Mokaddas 2016 {published data only}

Mokaddas EM, Saadaldeen H, Ahmad S. Comparison of two molecular methods and an automated liquid culture system for the early detection of Mycobacterium tuberculosis from both pulmonary and extrapulmonary specimens in Kuwait. International Journal of Mycobacteriology 2016;5 Suppl 1:S74-5. CENTRAL

More 2017 {published data only}

More SW, Parande MA, Kamble SW, Kamble MS. Profile of drug-resistant tuberculosis in Western Maharashtra. Journal of Family Medicine and Primary Care 2017;6(1):29-33. CENTRAL

Morozova 2016 {published data only}

Morozova TI, Salina T. The results of drug susceptibility testing of Mycobacterium tuberculosis to rifampicin by Xpert MTB/RIF BACTEC MGIT 960 as compared with the method of seeding on solid nutrient media. European Respiratory Journal. European Respiratory Society Annual Congress 2016;48(Suppl 60):PA2783. CENTRAL

Moure 2012 {published data only}

Moure R, Martin R, Alcaide F. Effectiveness of an integrated real-time PCR method for detection of the Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples in an area of low tuberculosis prevalence. Journal of Clinical Microbiology 2012;50(2):513-5. CENTRAL

Mukherjee 2017 {published data only}

Mukherjee S, Biswas D, Begum S, Ghosh P, Paul A, Sarkar S. Evaluation of cartridge based nucleic acid amplification test in diagnosis of pulmonary tuberculosis. JEMDS: Journal of Evolution of Medical and Dental Sciences 2017;6(74):5281-6. CENTRAL

Mulder 2017 {published data only}

Mulder C, Mgode GF, Ellis H, Valverde E, Beyene N, Cox C, et al. Accuracy of giant African pouched rats for diagnosing tuberculosis: comparison with culture and Xpert® MTB/RIF. International Journal of Tuberculosis and Lung Disease 2017;21(11):1127-33. CENTRAL

Muñoz 2013 {published data only}

Muñoz L, Moure R, Porta N, Gonzalez L, Guerra R, Alcaide F, et al. GeneXpert® for smear-negative pulmonary tuberculosis: does it play a role in low-burden countries? Diagnostic Microbiology Infectious Disease 2013;75(3):325-6. CENTRAL

Myneedu 2014 {published data only}

Myneedu VP, Behera D, Verma AK, Bhalla M, Singh N, Arora J, et al. Xpert® MTB/RIF assay for tuberculosis diagnosis: evaluation in an Indian setting. International Journal of Tuberculosis and Lung Disease 2014;18(8):958-60. CENTRAL

Naidoo 2016 {published data only}

Naidoo P, Dunbar R, Lombard C, Du Toit E, Caldwell J, Detjen A, et al. Comparing tuberculosis diagnostic yield in smear/culture and Xpert1 MTB/RIF-based algorithms using a non-randomised stepped-wedge design. PLOS ONE 2016;11(3):e0150487. CENTRAL

Narasimooloo 2012 {published data only}

Narasimooloo R, Ross A. Delay in commencing treatment for MDR TB at a specialised TB treatment centre in KwaZulu-Natal. South African Medical Journal 2012;102(6 Pt 2):360-2. CENTRAL

Ng 2018 {published data only}

Ng KC, Van Deun A, Meehan CJ, Torrea G, Driesen M, Gabriels S, et al. Xpert Ultra can unambiguously identify specific rifampin resistance-conferring mutations. Journal of Clinical Microbiology 2018;56(9):e00686-18. CENTRAL [DOI: 10.1128/JCM.00686-18]

Nguyen 2018 {published data only}

Nguyen VA, Nguyen HV, Dinh TV, Du HH, Do CN, Marks GB, et al. Evaluation of Loopamp™ MTBC detection kit for diagnosis of pulmonary tuberculosis at a peripheral laboratory in a high burden setting. Diagnostic Microbiology and Infectious Disease 2017;90(3):190-5. CENTRAL

Ngwira 2017 {published data only}

Ngwira LG, Khundi M, Barnes GL, Nkhoma A, Murowa M, Cohn S, et al. Screening for tuberculosis with Xpert MTB/RIF versus fluorescent microscopy among people newly diagnosed with HIV in rural Malawi: a cluster-randomized trial. Journal of the International AIDS Society 2017;20:93-4. CENTRAL

Nhu 2013 {published data only}

Nhu NT, Ha DT, Anh ND, Thu DD, Duong TN, Quang ND, et al. Evaluation of Xpert MTB/RIF and MODS assay for the diagnosis of pediatric tuberculosis. BMC Infectious Diseases 2013;13:31. CENTRAL

Nicol 2011 {published data only}

Nicol MP, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Accuracy of the Xpert MTB/RIF test for the diagnosis of pulmonary tuberculosis in children admitted to hospital in Cape Town, South Africa: a descriptive study. Lancet Infectious Diseases 2011;11(11):819-24. CENTRAL

Ninan 2016 {published data only}

Ninan MM, Gowri M, Christopher DJ, Rupali P, Michael JS. The diagnostic utility of line probe assays for multidrug-resistant tuberculosis. Pathogens and Global Health 2016;110(4-5):194-9. CENTRAL

Nosova 2013a {published data only}

Nosova EY, Krasnova MA, Galkina KY, Makarova MV, Litvinov VI, Moroz AM. Comparing performance of "TB-BIOCHIP", "Xpert MTB/RIF" and "genotype MTBDRplus" assays for fast identification of mutations in the Mycobacterium tuberculosis complex in sputum from TB patients. Molekuliarnaia Biologiia (Mosk) 2013;47(2):267-74. CENTRAL

Nosova 2013b {published data only}

Nosova EY, Krasnova MA, Galkina KY, Makarova MV, Litvinov VI, Moroz AM. Comparative analysis of TB Biochip, Xpert MTB/RIF, and GenoType MTBDRplus test systems for rapid determination of mutations responsible for drug resistance of M-tuberculosis complex (in sputum from patients in Moscow region). Molecular Biology (Moscow) 2013;47(2):236-41. CENTRAL

Ntinginya 2012 {published data only}

Ntinginya EN, Squire SB, Millington KA, Mtafya B, Saathoff E, Heinrich N, et al. Performance of the Xpert® MTB/RIF assay in an active case-finding strategy: a pilot study from Tanzania. International Journal of Tuberculosis and Lung Disease 2012;16(11):1468-70. CENTRAL

O'Grady 2012 {published data only}

O'Grady J, Bates M, Chilukutu L, Mzyece J, Cheelo B, Chilufya M, et al. Evaluation of the Xpert MTB/RIF assay at a tertiary care referral hospital in a setting where tuberculosis and HIV infection are highly endemic. Clinical Infectious Diseases 2012;55(9):1171-8. CENTRAL

Oliveira 2019 {published data only}

Oliveira MCB, Sant'Anna CC, Luiz RR, Soares ECC, Kritski AL. Contribution of Xpert MTB/RIF to clinical diagnosis in adolescents with tuberculosis in Rio de Janeiro, Brazil. International Journal of Tuberculosis and Lung Disease 2019;23(10):1115-21. CENTRAL

Omar 2019 {published data only}

Omar A, Elfadl AE, Ahmed Y, Hosny M. Genexpert test and tuberculous pleural effusion: a new diagnostic method for an old medical problem. Egyptian Journal of Chest Diseases and Tuberculosis 2019;68(4):493-7. CENTRAL

Omrani 2014 {published data only}

Omrani AS, Al-Otaibi MF, Al-Ateah SM, Al-Onazi FM, Baig K, El-Khizzi NA, et al. GeneXpert MTB/RIF testing in the management of patients with active tuberculosis; a real life experience from Saudi Arabia. Infection and Chemotherapy 2014;46(1):30-4. CENTRAL

Opota 2016 {published data only}

Opota O, Senn L, Prod'hom G, Mazza-Stalder J, Tissot F, Greub G, et al. Added value of molecular assay Xpert MTB/RIF compared to sputum smear microscopy to assess the risk of tuberculosis transmission in a low-prevalence country. Clinical Microbiology and Infection 2016;22(7):613-9. CENTRAL

Osman 2014 {published data only}

Osman M, Simpson JA, Caldwell J, Bosman M, Nicol MP. GeneXpert MTB/RIF version G4 for identification of rifampin-resistant tuberculosis in a programmatic setting. Journal of Clinical Microbiology 2014;52(2):635-7. CENTRAL

Ou 2015 {published data only}

Ou X, Xia H, Li Q, Pang Y, Wang S, Zhao B, et al. A feasibility study of the Xpert MTB/RIF test at the peripheral level laboratory in China. International Journal of Infectious Diseases 2015;31:41-6. CENTRAL

Ozkutuk 2014 {published data only}

Ozkutuk N, Surucüoglu S. Evaluation of the Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary tuberculosis in an intermediate-prevalence setting. Mikrobiyoloji Bulteni 2014;48(2):223-32. CENTRAL

Pandey P 2017 {published data only}

Pandey P, Pant ND, Rijal KR, Shrestha B, Kattel S, Banjara MR, et al. Diagnostic accuracy of GeneXpert MTB/RIF assay in comparison to conventional drug susceptibility testing method for the diagnosis of multidrug-resistant tuberculosis. PLOS ONE 2017;12(1):e0169798. CENTRAL

Pandey S 2017 {published data only}

Pandey S, Congdon J, McInnes B, Pop A, Coulter C. Evaluation of the GeneXpert MTB/RIF assay on extrapulmonary and respiratory samples other than sputum: a low burden country experience. Pathology 2017;49(1):70-4. CENTRAL

Parcell 2017 {published data only}

Parcell BJ, Jarchow-MacDonald AA, Seagar AL, Laurenson IF, Prescott GJ, Lockhart M. Three year evaluation of Xpert MTB/RIF in a low prevalence tuberculosis setting: a Scottish perspective. Journal of Infection 2017;74(5):466-72. CENTRAL

Patel 2020 {published data only}

Patel J, Upadhyay M, Kundnani V, Merchant Z, Jain S, Kire N. Diagnostic efficacy, sensitivity, and specificity of Xpert MTB/RIF assay for spinal tuberculosis and rifampicin resistance. Spine 2020;45(3):163-9. CENTRAL

Patil 2014 {published data only}

Patil N, Saba H, Marco A, Samant R, Mukasa L. Initial experience with GeneXpert MTB/RIF assay in the Arkansas Tuberculosis Control Program. Australasian Medical Journal 2014;7(5):203-7. CENTRAL

Patil 2017 {published data only}

Patil S, Narwade S, Mirza M. Bronchial wash Gene Xpert MTB/RIF in lower lung field tuberculosis: sensitive, superior, and rapid in comparison with conventional diagnostic techniques. Journal of Translational Internal Medicine 2017;5(3):174-81. CENTRAL

Peter 2012 {published data only}

Peter JG, Theron G, Muchinga TE, Govender U, Dheda K. The diagnostic accuracy of urine-based Xpert MTB/RIF in HIV-infected hospitalized patients who are smear-negative or sputum scarce. PLOS ONE 2012;7(7):e39966. CENTRAL

Peter 2013 {published data only}

Peter JG, Theron G, Pooran A, Thomas J, Pascoe M, Dheda K. Comparison of two methods for acquisition of sputum samples for diagnosis of suspected tuberculosis in smear-negative or sputum-scarce people: a randomised controlled trial. Lancet Respiratory Medicine 2013;1(6):471-8. CENTRAL

Peter 2015 {published data only}

Peter J, Theron G, Chanda D, Clowes P, Rachow A, Lesosky M, et al. Test characteristics and potential impact of the urine LAM lateral flow assay in HIV-infected outpatients under investigation for TB and able to self-expectorate sputum for diagnostic testing. BMC Infectious Diseases 2015;15:262. CENTRAL

Qureshi 2019 {published data only}

Qureshi S, Sohaila A, Hannan S, Amir Sheikh MD, Qamar FN. Comparison of Xpert MTB/RIF with AFB smear and AFB culture in suspected cases of paediatric tuberculosis in a tertiary care hospital, Karachi. Journal of the Pakistan Medical Association 2019;69(9):1273-8. CENTRAL

Rachow 2012 {published data only}

Rachow A, Clowes P, Saathoff E, Mtafya B, Michael E, Ntinginya EN, et al. Increased and expedited case detection by Xpert MTB/RIF assay in childhood tuberculosis: a prospective cohort study. Clinical Infectious Diseases 2012;54(10):1388-96. CENTRAL

Rahman 2016 {published data only}

Rahman A, Sahrin M, Afrin S, Earley K, Ahmed S, Rahman SM, et al. Comparison of Xpert MTB/RIF assay and GenoType MTBDRplus DNA probes for detection of mutations associated with rifampicin resistance in Mycobacterium tuberculosis. PLOS ONE 2016;11(4):e0152694. CENTRAL

Raizada 2015 {published data only}

Raizada N, Sachdeva KS, Sreenivas A, Kulsange S, Gupta RS, Thakur R, et al. Catching the missing million: experiences in enhancing TB & DR-TB detection by providing upfront Xpert MTB/RIF testing for people living with HIV in India. PLOS ONE 2015;10(2):e0116721. CENTRAL

Ramamurthy 2016 {published data only}

Ramamurthy K, Bhat S, Shenoy S, Rangnekar A. Xpert Mycobacterium tuberculosis/rifampicin assay: a boon in tuberculosis diagnostics. Asian Journal of Pharmaceutical and Clinical Research 2016;9(5):225-7. CENTRAL

Ramirez 2014 {published data only}

Ramirez HL, Garcia-Clemente MM, Alvarez-Alvarez C, Palacio-Gutierrez JJ, Pando-Sandoval A, Gagatek S, et al. Impact of the Xpert® MTB/RIF molecular test on the late diagnosis of pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2014;18(4):435-7. CENTRAL

Rasheed 2019 {published data only}

Rasheed W, Rao NA, Adel H, Baig MS, Adil SO. Diagnostic accuracy of Xpert MTB/RIF in sputum smear-negative pulmonary tuberculosis. Cureus 2019;11(8):e5391. CENTRAL

Rathish 2019 {published data only}

Rathish B, Wilson A, Pillay R, Warrier A, Philips G. A bundled approach to pulmonary tuberculosis testing: experience from a tertiary care centre in South India. Cureus 2019;11(10):e6042. CENTRAL

Rathour 2019 {published data only}

Rathour JS, Mantan M, Khanna A, Hanif M. Evaluation of Gene Xpert assay in extrapulmonary tuberculosis in children. JEMDS: Journal of Evolution of Medical and Dental Sciences2019;8(1). CENTRAL

Reechaipichitkul 2016 {published data only}

Reechaipichitkul W, Phetsuriyawong A, Chaimanee P, Ananta P. Diagnostic test of sputum GeneXpert MTB/RIF for smear negative pulmonary tuberculosis. Southeast Asian Journal of Tropical Medicine and Public Health 2016;47(3):457-66. CENTRAL

Reechaipichitkul 2017 {published data only}

Reechaipichitkul W, Suleesathira T, Chaimanee P. Comparison of GeneXpert MTB/RIF assay with conventional AFB smear for diagnosis of pulmonary tuberculosis in northeastern Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 2017;48(2):313-21. CENTRAL

Reed 2016 {published data only}

Reed JL, Walker ZJ, Basu D, Allen V, Nicol MP, Kelso DM, et al. Highly sensitive sequence specific qPCR detection of Mycobacterium tuberculosis complex in respiratory specimens. Tuberculosis (Edinb) 2016;101:114-24. CENTRAL

Rees 2018 {published data only}

Rees K, Muditambi N, Maswanganyi M, Railton J, McIntyre JA, Struthers HE, et al. The impact of implementing a Xpert MTB/RIF algorithm on drug-sensitive pulmonary tuberculosis: a retrospective analysis. Epidemiology & Infection 2018;146:246–55. CENTRAL

Reis 2019 {published data only}

Reis AJ, Diniz J, Silva ABS, Silveira J, Basso R, Vieira R, et al. Laboratory tools for tuberculosis control in a setting with a high burden of HIV/AIDS. Journal of Medical Microbiology 2019;68(11):1622-8. CENTRAL

Rivera 2019 {published data only}

Rivera VR, Lu L, Ocheretina O, Jean Juste MA, Julma P, Archange D, et al. Diagnostic yield of active case finding for tuberculosis at human immunodeficiency virus testing in Haiti. International Journal of Tuberculosis and Lung Disease 2019;23(11):1217-22. CENTRAL

Rossato 2018 {published data only}

Rossato Silva D, Sotgiu G, D'Ambrosio L, Rodrigues Pereira G, Silva Barbosa M, Dutra Dias NJ, et al. Diagnostic performances of the Xpert MTB/RIF in Brazil. Respiratory Medicine 2018;134:12-5. CENTRAL

Rufai 2014 {published data only}

Rufai SB, Kumar P, Singh A, Prajapati S, Balooni V, Singh S. Comparison of Xpert MTB/RIF with line probe assay for detection of rifampin-monoresistant Mycobacterium tuberculosis. Journal of Clinical Microbiology2014;52(6):1846-52. CENTRAL

Ruiz 2017 {published data only}

Ruiz P, Causse M, Vaquero M, Gutierrez JB, Casal M. Evaluation of a new automated Abbott RealTime MTB RIF/INH assay for qualitative detection of rifampicin/isoniazid resistance in pulmonary and extra-pulmonary clinical samples of Mycobacterium tuberculosis. Infection and Drug Resistance 2017;10:463-7. CENTRAL

Sachdeva 2015 {published data only}

Sachdeva KS, Raizada N, Sreenivas A, Van't Hoog AH, Van den Hof S, Dewan PK, et al. Use of Xpert MTB/RIF in decentralized public health settings and its effect on pulmonary TB and DR-TB case finding in India. PLOS ONE 2015;10(5):e0126065. CENTRAL

Saeed 2017 {published data only}

Saeed M, Iram S, Hussain S, Ahmed A, Akbar M, Aslam M. GeneXpert: a new tool for the rapid detection of rifampicin resistance in mycobacterium tuberculosis. Journal of the Pakistan Medical Association 2017;67(2):270-4. CENTRAL

Sanchez‐Padilla 2015 {published data only}

Sanchez-Padilla E, Merker M, Beckert P, Jochims F, Dlamini T, Kahn P, et al. Detection of drug-resistant tuberculosis by Xpert MTB/RIF in Swaziland. New England Journal of Medicine 2015;372(12):1181-2. CENTRAL

Sauzullo 2016 {published data only}

Sauzullo I, Rodio DM, Facchinetti S, Puggioni G, De Angelis M, Goldoni P, et al. Diagnostic accuracy of Xpert MTB/RIF versus smear microscopy in the early diagnosis tuberculosis in the real life of "Umberto I" Hospital Rome. New Microbiologica 2016;39(4):304-6. CENTRAL

Schutz 2019 {published data only}

Schutz C, Ward A, Burton R, Nicol MP, Blumenthal L, Meintjes G, et al. False rifampicin resistant results using Xpert MTB/RIF on urine samples in hospitalised HIV-infected patients. Southern African Journal of HIV Medicine 2019;20(1):978. CENTRAL

Set 2019 {published data only}

Set R, Bankar S, Sharma D, Shah D, Shastri J. Performance of Xpert MTB/RIF for detection of Mycobacterium tuberculosis and rifampicin resistance in pus aspirates. Indian Journal of Tuberculosis 2019;66(4):433-6. CENTRAL

Shah 2014 {published data only}

Shah M, Ssengooba W, Armstrong D, Nakiyingi L, Holshouser M, Ellner JJ, et al. Comparative performance of urinary lipoarabinomannan assays and Xpert MTB/RIF in HIV-infected individuals. AIDS 2014;28(9):1307-14. CENTRAL

Shah 2020 {published data only}

Shah M, Paradis S, Betz J, Beylis N, Bharadwaj R, Caceres T, et al. Multicenter study of the accuracy of the BD MAX MDR-TB assay for detection of Mycobacterium tuberculosis Complex and mutations associated with resistance to rifampin and isoniazid. Clinical Infectious Diseases 2020;71(5):1161-7. CENTRAL [DOI: 10.1093/cid/ciz932]

Sharma 2019 {published data only}

Sharma K, Gupta A, Sharma M, Sharma A, Bansal R, Sharma SP, et al. The emerging challenge of diagnosing drug-resistant tubercular uveitis: experience of 110 eyes from North India. Ocular Immunology and Inflammation 2019;Oct 3:1-8. CENTRAL

Shenai 2013 {published data only}

Shenai S, Amisano D, Ronacher K, Kriel M, Banada PP, Song T, et al. Exploring alternative biomaterials for diagnosis of pulmonary tuberculosis in HIV-negative patients by use of the GeneXpert MTB/RIF assay. Journal of Clinical Microbiology 2013;51(12):4161-6. CENTRAL

Shenoy 2019 {published data only}

Shenoy VP, Kumar A, Chawla K. Diagnostic performance of Xpert MTB /RIF in comparison with LED fluorescence microscopy and culture in suspected cases of pulmonary tuberculosis. Journal of Pure and Applied Microbiology 2019;13(3):1461-5. CENTRAL

Shilpa 2017 {published data only}

Shilpa, Nadagir SD, Jnaneshwara KB, Patil AB, Pendari AG, Chikkaraddi U. Detection of rifampicin resistance in HIV seropositive individuals with suspected pulmonary tuberculosis by using CBNAAT. Journal of Pure and Applied Microbiology 2017;11(1):387-92. CENTRAL

Simone 2019 {published data only}

Simone A. Comparative analysis of the bacilloscopy technique in the diagnosis of pulmonary tuberculosis against GeneXpert in samples of patients in the city of Recife, Pernambuco [Análise comparativa da técnica de baciloscopia no diagnóstico da tuberculose pulmonar frente ao GeneXpert em amostras de pacientes da cidade de Recife, Pernambuco]. Revista Brasileira de Análises Clínicas 2019;51(1):65-9. CENTRAL

Singh 2019 {published data only}

Singh M, Sethi GR, Mantan M, Khanna A, Hanif M. Respiratory specimens for the diagnosis of pediatric pulmonary tuberculosis: a Comparative Assessment. SN Comprehensive Clinical Medicine 2019;1(12):1056-9. CENTRAL

Smith 2014 {published data only}

Smith P, Van Esch A, Wallace M, Wood R, Bekker LG. GeneXpert TB 8: a point-of-care diagnostic pilot. South African Medical Journal 2014;104(8):524. CENTRAL

Somashekar 2014 {published data only}

Somashekar N, Chadha VK, Praseeja P, Sharada MA, Chandrakala GR, Srivastava R, et al. Role of pre-Xpert(R) screening using chest X-ray in early diagnosis of smear-negative pulmonary tuberculosis. International Journal of Tuberculosis and Lung Disease 2014;18(10):1243-4. CENTRAL

Somily 2016 {published data only}

Somily AM, Barry MA, Habib HA, Alotaibi FE, Al-Zamil FA, Khan MA, et al. Evaluation of GeneXpert MTB/RIF for detection of Mycobacterium tuberculosis complex and rpo B gene in respiratory and non-respiratory clinical specimens at a tertiary care teaching hospital in Saudi Arabia. Saudi Medical Journal 2016;37(12):1404-7. CENTRAL

Strydom 2015 {published data only}

Strydom K, Ismail F, Matabane MM, Onwuegbuna O, Omar SV, Ismail N. Comparison of three commercial molecular assays for detection of rifampin and isoniazid resistance among Mycobacterium tuberculosis isolates in a high-HIV-prevalence setting. Journal of Clinical Microbiology 2015;53(9):3032-4. CENTRAL

Sumalani 2019 {published data only}

Sumalani KK, Akhter N, Chawla D, Rizvi NA. Diagnostic yield of sputum induction in patients with pleural tuberculosis at a tertiary care hospital in Karachi. International Journal of Tuberculosis and Lung Disease 2019;23(11):1213-6. CENTRAL

Sumayya 2019 {published data only}

Sumayya, Durga K, Nithyananda BS, Fatima S, Krishnaiah A. Study of CBNAAT and anti-MPT64 detection in cytological and histopathological material for early diagnosis of TB lymphadenitis. Journal of Evolution of Medical and Dental Sciences 2019;8(47):3540-4. CENTRAL

Sun 2019 {published data only}

Sun L, Qi X, Liu F, Wu X, Yin Q, Guo Y, et al. A test for more accurate diagnosis of pulmonary tuberculosis. Pediatrics2019;144(5):e20190262. CENTRAL

Sureshbabu 2016 {published data only}

Sureshbabu R, Lakshmi Murali A, Palaniswamy M. Molecular diagnosis of drug resistance tuberculosis in the districts of Tamilnadu. International Journal of Pharma and Bio Sciences 2016;7(4):B42-6. CENTRAL

Tadesse 2016 {published data only}

Tadesse M, Aragaw D, Dimah B, Efa F, Abebe G. Xpert MTB/RIF for rapid detection of rifampicin-resistant Mycobacterium tuberculosis from pulmonary tuberculosis patients in southwest Ethiopia. International Journal of Mycobacteriology 2016;5 Suppl 1:S48-9. CENTRAL

Tahseen 2016 {published data only}

Tahseen S, Qadeer E, Khanzada FM, Rizvi AH, Dean A, Van Deun A, et al. Use of Xpert® MTB/RIF assay in the first national anti-tuberculosis drug resistance survey in Pakistan. International Journal of Tuberculosis and Lung Disease 2016;20(4):448-55. CENTRAL

Tahseen 2019 {published data only}

Tahseen S, Ambreen A, Masood F, Qadir M, Hussain A, Jamil M, et al. Primary drug resistance in extra-pulmonary tuberculosis: a hospital-based prospective study from Pakistan. International Journal of Tuberculosis and Lung Disease 2019;23(8):900-6. CENTRAL

Talib 2019 {published data only}

Talib A, Bhatty S, Mehmood K, Naim H, Haider I, Lal H, et al. GeneXpert in stool: diagnostic yield in intestinal tuberculosis. Journal of Clinical Tuberculosis and Other Mycobacterial Diseases 2019;17:100131. CENTRAL

Tan 2017 {published data only}

Tan Y, Li Q, Wang Q, Sun H, Chen J, Cai X, et al. Evaluation of the MTBDRplus 2.0 assay for the detection of multidrug resistance among persons with presumptive pulmonary TB in China. Science Reports 2017;7(1):3364. CENTRAL

Taylor 2012 {published data only}

Taylor N, Gaur RL, Baron EJ, Banaei N. Can a simple flotation method lower the limit of detection of Mycobacterium tuberculosis in extrapulmonary samples analyzed by the GeneXpert MTB/RIF assay? Journal of Clinical Microbiology 2012;50(7):2272-6. CENTRAL

Teo 2011 {published data only}

Teo J, Jureen R, Chiang D, Chan D, Lin R. Comparison of two nucleic acid amplification assays, the Xpert MTB/RIF and the amplified Mycobacterium tuberculosis Direct assay, for the detection of Mycobacterium tuberculosis in respiratory and non-respiratory specimens. Journal of Clinical Microbiology 2011;49(10):3659-62. CENTRAL

Theron 2012 {published data only}

Theron G, Peter J, Lenders L, Van Zyl-Smit R, Meldau R, Govender U, et al. Correlation of mycobacterium tuberculosis specific and non-specific quantitative Th1 T-cell responses with bacillary load in a high burden setting. PLOS ONE 2012;7(5):e37436. CENTRAL

Theron 2014a {published data only}

Theron G, Peter J, Calligaro G, Meldau R, Hanrahan C, Khalfey H, et al. Determinants of PCR performance (Xpert MTB/RIF), including bacterial load and inhibition, for TB diagnosis using specimens from different body compartments. Science Reports 2014;4:5658. CENTRAL

Theron 2016 {published data only}

Theron G, Venter R, Calligaro G, Smith L, Limberis J, Meldau R, et al. Xpert MTB/RIF results in patients with previous tuberculosis: can we distinguish true from false positive results? Clinical Infectious Diseases 2016;62(8):995-1001. CENTRAL

Theron 2018 {published data only}

Theron G, Venter R, Smith L, Esmail A, Randall P, Sood V, et al. False positive Xpert MTB/RIF results in re-tested patients with previous tuberculosis: frequency, profile, and prospective clinical outcomes. Journal of Clinical Microbiology 2018;56(3):e01696-17. CENTRAL

Thibbadee 2016 {published data only}

Thibbadee C. Evaluation of decentralised use of the Xpert MTB/RRIF test for diagnosis of tuberculosis and multidrug resistance in Rayong hospital, Thailand. Respirology 2016;21 (Suppl 3):198. CENTRAL

Thit 2017 {published data only}

Thit SS, Aung NM, Htet ZW, Boyd MA, Saw HA, Anstey NM, et al. The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study. BMC Medicine 2017;15(1):145. CENTRAL

To 2017 {published data only}

To KW, Kam KM, Lee SS, Chan KP, Yip T, Lo R, et al. Clinical application of GeneXpert on BAL samples in management of TB in intermediate burden area. Chest 2017;152 (4 Suppl 1):A194. CENTRAL

Tortoli 2012 {published data only}

Tortoli E, Russo C, Piersimoni C, Mazzola E, Dal Monte P, Pascarella M, et al. Clinical validation of Xpert MTB/RIF for the diagnosis of extrapulmonary tuberculosis. European Respiratory Journal 2012;40(2):442-7. CENTRAL

Uddin 2019 {published data only}

Uddin MJ, Rahim MA, Hasan MN, Mazumder MK, Haq MM, Rahman MA, et al. Etiological evaluation of patients with lymphadenopathy by clinical, histopathological and microbiological assessment. Mymensingh Medical Journal 2019;28(4):854-61. CENTRAL

Udgirkar 2019 {published data only}

Udgirkar S, Jain S, Pawar S, Chandnani S, Contractor Q, Rathi P. Clinical profile, drug resistance pattern and treatment outcomes of abdominal tuberculosis patients in western India. Archives of Gastroenterology 2019;56(2):178-83. CENTRAL

Ullah 2016 {published data only}

Ullah I, Shah AA, Basit A, Ali M, Khan A, Ullah U, et al. Rifampicin resistance mutations in the 81 bp RRDR of rpoB gene in Mycobacterium tuberculosis clinical isolates using Xpert MTB/RIF in Khyber Pakhtunkhwa, Pakistan: a retrospective study. BMC Infectious Diseases 2016;16:413. CENTRAL

Ullah 2017 {published data only}

Ullah I, Javaid A, Masud H, Ali M, Basit A, Ahmad W, et al. Rapid detection of Mycobacterium tuberculosis and rifampicin resistance in extrapulmonary tuberculosis and sputum smear-negative pulmonary suspects using Xpert MTB/RIF. Journal of Medical Microbiology 2017;66(4):412-8. CENTRAL

Vadwai 2011 {published data only}

Vadwai V, Boehme C, Nabeta P, Shetty A, Alland D, Rodrigues C. Xpert MTB/RIF: a new pillar in diagnosis of extrapulmonary tuberculosis? Journal of Clinical Microbiology 2011;49(7):2540-5. CENTRAL

Van Kampen 2015 {published data only}

Van Kampen SC, Tursynbayeva A, Koptleuova A, Murzakhmetova Z, Bigalieva L, Aubakirova M, et al. Effect of introducing Xpert MTB/RIF to test and treat individuals at risk of multidrug-resistant tuberculosis in Kazakhstan: a prospective cohort study. PLOS ONE 2015;10(7):e0132514. CENTRAL

Van Rie 2011 {published data only}

Van Rie A. A single Xpert MTB/RIF test of sputum for diagnosis of tuberculosis and multidrug resistance shows high sensitivity and specificity and reduces diagnosis and treatment delays. BMJ Evidence-Based Medicine 2011;16(6):174-5. CENTRAL

Walters 2012 {published data only}

Walters E, Gie RP, Hesseling AC, Friedrich SO, Diacon AH. Rapid diagnosis of pediatric intrathoracic tuberculosis from stool samples using the Xpert MTB/RIF Assay: a pilot study. Pediatric Infectious Disease Journal 2012;31(12):1316. CENTRAL

Walusimbi 2013 {published data only}

Walusimbi S, Bwanga F, De Costa A, Haile M, Joloba M, Hoffner S. Meta-analysis to compare the accuracy of GeneXpert, MODS and the WHO 2007 algorithm for diagnosis of smear-negative pulmonary tuberculosis. BMC Infectious Diseases 2013;13:507. CENTRAL

Wang 2015 {published data only}

Wang XW, Pappoe F, Huang Y, Cheng XW, Xu DF, Wang H, et al. Xpert MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in children: a meta-analysis. Clinical Laboratory 2015;61(11):1775-85. CENTRAL

Wang 2016 {published data only}

Wang SF, Ou XC, Li Q, Zheng HW, Wang YF, Zhao YL. The Abbott RealTime MTB assay and the Cepheid GeneXpert assay show comparable performance for the detection of Mycobacterium tuberculosis in sputum specimens. International Journal of Infectious Diseases 2016;45:78-80. CENTRAL

Williamson 2012 {published data only}

Williamson DA, Roberts SA, Bower JE, Vaughan R, Newton S, Lowe O, et al. Clinical failures associated with rpoB mutations in phenotypically occult multidrug-resistant Mycobacterium tuberculosis . International Journal of Tuberculosis and Lung Disease 2012;16(2):216-20. CENTRAL

Wood 2012 {published data only}

Wood R, Racow K, Bekker LG, Middelkoop K, Vogt M, Kreiswirth BN, et al. Lipoarabinomannan in urine during tuberculosis treatment: association with host and pathogen factors and mycobacteriuria. BMC Infectious Diseases 2012;12:47. CENTRAL

Xie 2017 {published data only}

Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, et al. Evaluation of a rapid molecular drug-susceptibility test for tuberculosis. New England Journal of Medicine 2017;377(11):1043-54. CENTRAL

Yadav 2017 {published data only}

Yadav R, Sharma N, Khaneja R, Agarwal P, Kanga A, Behera D, et al. Evaluation of the TB-LAMP assay for the rapid diagnosis of pulmonary tuberculosis in northern India. International Journal of Tuberculosis and Lung Disease 2017;21(10):1150-3. CENTRAL

Yan 2016 {published data only}

Yan L, Xiao H, Zhang Q. Systematic review: Comparison of Xpert MTB/RIF, LAMP and SAT methods for the diagnosis of pulmonary tuberculosis. Tuberculosis (Edinb) 2016;96:75-86. CENTRAL

Yang X 2020 {published data only}

Yang X, Che N, Duan H, Liu Z, Li K, Li H, et al. Cell-free Mycobacterium tuberculosis DNA test in pleural effusion for tuberculous pleurisy: a diagnostic accuracy study. Clinical Microbiology and Infection2020;26(8):1089.e1-1089.e6. CENTRAL

Yeong 2019 {published data only}

Yeong C, Byrne AL, Cho JG, Sintchenko V, Crighton T, Marais BJ. Use of GeneXpert MTB/RIF(R) on a single pooled sputum specimen to exclude pulmonary tuberculosis among hospital inpatients placed in respiratory isolation. International Journal of Infectious Diseases 2019;92:175-80. CENTRAL

Yu 2020 {published data only}

Yu G, Shen Y, Ye B, Chen D, Xu K. Comparison of CapitalBio Mycobacterium nucleic acid detection test and Xpert MTB/RIF assay for rapid diagnosis of extrapulmonary tuberculosis. Journal of Microbiological Methods 2020;168:105780. CENTRAL

Zar 2012 {published data only}

Zar HJ, Workman L, Isaacs W, Munro J, Black F, Eley B, et al. Rapid molecular diagnosis of pulmonary tuberculosis in children using nasopharyngeal specimens. Clinical Infectious Diseases 2012;55(8):1088-95. CENTRAL

Zar 2019 {published data only}

Zar HJ, Workman LJ, Prins M, Bateman LJ, Mbhele SP, Whitman CB, et al. Tuberculosis diagnosis in children using Xpert Ultra on different respiratory specimens. Amercian Journal of Respiratory and Critical Care Medicine 2019;200(12):1531-8. CENTRAL

Zemlyansky 2016 {published data only}

Zemlyansky OA, Tyurina EB, Bashkirev AA, Kalyuzhnaya EV, Zemlyanskaya LO. Experience and efficiency of laboratory diagnosis of tuberculosis with PCR detector system GeneXpert in Belgorod region. International Journal of Pharmacy and Technology 2016;8(4):27072-9. CENTRAL

Zhou 2020 {published data only}

Zhou Z, Zheng Y, Wang L. A comparative study on the value of Xpert MTB/RIF and T-SPOT.TB tests in the diagnosis of bone and joint tuberculosis. Clinica Chimica Acta2020;500:115-9. CENTRAL

Zimba 2019 {published data only}

Zimba O, Tamuhla T, Basotli J, Letsibogo G, Pals S, Mathebula U, et al. The effect of sputum quality and volume on the yield of bacteriologically-confirmed TB by Xpert MTB/RIF and smear. Pan African Medical Journal 2019;33:110. CENTRAL

Zurcher 2019 {published data only}

Zurcher K, Ballif M, Kiertiburanakul S, Chenal H, Yotebieng M, Grinsztejn B, et al. Diagnosis and clinical outcomes of extrapulmonary tuberculosis in antiretroviral therapy programmes in low- and middle-income countries: a multicohort study. Journal of the International AIDS Society 2019;22(9):e25392. CENTRAL

ChiCTR180001479 {published data only}

ChiCTR1800014792. Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study [Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study]. http://www.chictr.org.cn/showproj.aspx?proj=25172 (first received 5 February 2018). CENTRAL

ChiCTR1800014792 {published data only}

ChiCTR1800014792. Study on the accuracy of fecal Xpert_MTB/RIF_Ultra test in diagnosis of childhood tuberculosis [Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV-infected adults: a prospective cohort study]. http://www.chictr.org.cn/showproj.aspx?proj=25233 (first received 12 February 2018). CENTRAL

ChiCTR1900026491 {unpublished data only}

ChiCTR1900026491. The diagnostic value of medical thoracoscopy combined with Xpert MTB/RIF Ultra in smear and culture negative pulmonary tuberculosis [The diagnostic value of medical thoracoscopy combined with Xpert MTB/RIF Ultra in smear and culture negative pulmonary tuberculosis]. http://www.chictr.org.cn/showproj.aspx?proj=44194 (first received 12 October 2019). CENTRAL

ISRCTN77241966 {published data only}

ISRCTN77241966. Evaluation of GeneXpert Ultra and digital chest radiography for diagnosing tuberculosis [Utility of the Xpert® MTB/RIF Ultra assay with the GeneXpert®Omni System and digital chest radiography for diagnosis of tuberculosis in high HIV prevalence settings: protocol for a randomised control trial]. www.isrctn.com/ISRCTN77241966 (first received 9 February 2019). CENTRAL

NCT03154320 {published data only}NCT03154320

NCT03154320. A trial of same-day testing and treatment to improve outcomes among symptomatic patients newly diagnosed with HIV [A trial of same-day testing and treatment to improve outcomes among symptomatic patients newly diagnosed with HIV]. clinicaltrials.gov/ct2/show/NCT03154320 (first received 16 May 2017). CENTRAL

NCT03187964 {published data only}NCT03187964

NCT03187964. Xpert Ultra and Xpert HIV-VL in people living with HIV (Ultra HIV) [Xpert Ultra and Xpert HIV-VL in people living with HIV (Ultra HIV)]. clinicaltrials.gov/ct2/show/NCT03187964 (first received 15 June 2017). CENTRAL

NCT03356925 {published data only}NCT03356925

NCT03356925. Improving tuberculosis diagnosis and treatment through basic, applied and health systems research (BAR) [Improving tuberculosis diagnosis and treatment through basic, applied and health systems research (BAR)]. clinicaltrials.gov/ct2/show/NCT03356925 (first received 29 November 2017). CENTRAL

NCT03497195 {published data only}NCT03497195

NCT03497195. Achieving tuberculosis (TB) control In Zambia (TB) [Comparison of 2 diagnostic tools (chest X-ray with computer-assisted diagnosis versus C-reactive protein) and Xpert Ultra for active community-based tuberculosis case detection]. clinicaltrials.gov/ct2/show/NCT03497195 (first received 13 April 2018). CENTRAL

NCT03712709 {unpublished data only}NCT03712709

NCT03712709. Clinical evaluation of the Truenat point-of-care tuberculosis diagnostic test [Clinical evaluation of the Truenat point-of-care tuberculosis diagnostic test]. clinicaltrials.gov/ct2/show/NCT03712709 (first received 19 October 2018). CENTRAL

NCT04074369 {unpublished data only}NCT04074369

NCT04074369. Evaluation of CRISPR-based test for the rapid identification of TB in pulmonary tuberculosis suspects [Evaluation of CRISPR-based test for the rapid identification of TB in pulmonary tuberculosis suspects]. clinicaltrials.gov/ct2/show/NCT04074369 (first received 30 August 2019). CENTRAL

NCT04122404 {unpublished data only}NCT04122404

NCT04122404. POC strategies to improve TB care in advanced HIV disease (TBPOC) [Point-of-care strategies to improve tuberculosis care among severely immunosuppressed HIV-infected patients]. clinicaltrials.gov/ct2/show/NCT04122404 (first received 10 October 2019). CENTRAL [NCT04122404]

NCT058236 {unpublished data only}NCT058236

NTC02758236. Tuberculosis research of INA-RESPOND on drug resistance (TRIPOD) [Tuberculosis research of INA-RESPOND on drug resistance]. clinicaltrials.gov/ct2/show/NCT02758236 (first received 2 May 2016). CENTRAL

Altman 1995

Altman DD, Bland JM. Absence of evidence is not evidence of absence. BMJ 1995;311(7003):485.

American Thoracic Society 2000

American Thoracic Society, the Centers for Disease Control and Prevention, Infectious Disease Society of America. Diagnostic Standards and Classification of Tuberculosis in Adults and Children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. This statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. American Journal of Respiratory and Critical Care Medicine 2000;161(4 Pt 1):1376-95.

Balshem 2011

Balshem H, Helfand M, Schünemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. Journal of Clinical Epidemiology 2011;64(4):401-6.

Banada 2010

Banada PP, Sivasubramani SK, Blakemore R, Boehme C, Perkins MD, Fennelly K, et al. Containment of bioaerosol infection risk by the Xpert MTB/RIF assay and its applicability to point-of-care settings. Journal of Clinical Microbiology 2010;48(10):3551-7.

Beynon 2018

Beynon F, Theron G, Respeito D, Mambuque E, Saavedra B, Bulo H, et al. Correlation of Xpert MTB/RIF with measures to assess Mycobacterium tuberculosis bacillary burden in high HIV burden areas of Southern Africa. Scientific Reports 2018;8(1):5201.

Bjerrum 2019

Bjerrum S, Schiller I, Dendukuri N, Kohli M, Nathavitharana RR, Zwerling AA, et al. Lateral flow urine lipoarabinomannan assay for detecting active tuberculosis in people living with HIV. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No: CD011420. [DOI: 10.1002/14651858.CD011420.pub3]

Blakemore 2010

Blakemore R, Story E, Helb D, Kop J, Banada P, Owens MR, et al. Evaluation of the analytical performance of the Xpert MTB/RIF assay. Journal of Clinical Microbiology 2010;48(7):2495-501.

Boehme 2010

Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, et al. Rapid molecular detection of tuberculosis and rifampin resistance. New England Journal of Medicine 2010;363(11):1005–15.

Bossuyt 2015

Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527. [DOI: 10.1136/bmj.h5527]

Boyles 2014

Boyles TH, Hughes J, Cox V, Burton R, Meintjes G, Mendelson M. False-positive Xpert® MTB/RIF assays in previously treated patients: need for caution in interpreting results. International Journal of Tuberculosis and Lung Disease 2014;18(7):876-8.

Branigan 2019

Branigan D, Treatment Action Group. The tuberculosis diagnostics pipeline: new tests, same barriers. treatmentactiongroup.org/wp-content/uploads/2019/12/pipeline_tb_diagnotics_2019_db_final.pdf (accessed 9 April 2020).

Broger 2020

Broger T, Nicol MP, Székely R, Bjerrum S, Sossen B, Schutz C, et al. Diagnostic accuracy of a novel tuberculosis point-of-care urine lipoarabinomannan assay for people living with HIV: a meta-analysis of individual in- and outpatient data. PLOS Medicine 2020;17(5):e1003113.

Buzoianu 2008

Buzoianu M, Kadane JB. Adjusting for verification bias in diagnostic test evaluation: a Bayesian approach. Statistics in Medicine 2008;27(13):2453-73.

Cazabon 2018

Cazabon D, Pande T, Kik S, Van Gemert W, Sohn H, Denkinger C, et al. Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: a trend analysis from 2014 - 2016 [version 2; referees: 4 approved]. Gates Open Research 2018;2:35. [DOI: 10.12688/gatesopenres.12842.1]

CDC 2020

Centers for Disease Control and Prevention. Questions and answers about TB. www.cdc.gov/tb/publications/faqs/qa_introduction.htm (accessed 8 December 2020).

Cepheid 2018

Cepheid. Brochure: Xpert® MTB/RIF Ultra. www.cepheid.com/en/tests/Critical-Infectious-Diseases/Xpert-MTB-RIF-Ultra (accessed 26 March 2020).

Cepheid 2019

Cepheid. Xpert® MTB/RIF. Two-hour detection of MTB and rifampin resistance mutations. www.cepheid.com/Package%20Insert%20Files/Xpert-MTB-RIF-ENGLISH-Package-Insert-301-1404-Rev-F.pdf (accessed 29 March 2020).

Chang 2012

Chang K, Lu W, Wang J, Zhang K, Jia S, Li F, et al. Rapid and effective diagnosis of tuberculosis and rifampicin resistance with Xpert MTB/RIF assay: a meta-analysis. Journal of Infection 2012;64(6):580-8.

Chu 2006

Chu H, Cole SR. Bivariate meta-analysis of sensitivity and specificity with sparse data: a generalized linear mixed model approach. Journal of Clinical Epidemiology 2006;59(12):1331–2.

Chu 2009

Chu H, Chen S, Louis TA. Random effects models in a meta-analysis of the accuracy of two diagnostic tests without a gold standard. Journal of the American Statistical Association 2009;104(486):512–23.

Covidence [Computer program]

Veritas Health InnovationCovidence. Version accessed 27 January 2020. Melbourne, Australia: Veritas Health Innovation. Available at covidence.org.

Denamps 2020 [pers comm]

Denamps S. Quick Xpert Ultra question, market penetration [personal communication]. Email to: S Denamps 18 May 2020.

Di Tanna 2019

Di Tanna GL, Khaki AR, Theron G, McCarthy K, Cox H, Mupfumi L, et al. Effect of Xpert MTB/RIF on clinical outcomes in routine care settings: individual patient data meta-analysis. Lancet Global Health 2019;7:e191-9.

Flores 2005

Flores LL, Pai M, Colford JM Jr, Riley LW. In-house nucleic acid amplification tests for the detection of Mycobacterium tuberculosis in sputum specimens: meta-analysis and meta-regression. BMC Microbiology 2005;5:55.

Friedrich 2013

Friedrich SO, Rachow A, Saathoff E, Singh K, Mangu CD, Dawson R, et al Pan African Consortium for the Evaluation of Anti-tuberculosis Antibiotics (PanACEA). Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment. Lancet Respiratory Medicine 2013;1(6):462-70.

Getahun 2007

Getahun H, Harrington M, O'Brien R, Nunn P. Diagnosis of smear-negative pulmonary tuberculosis in people with HIV infection or AIDS in resource-constrained settings: informing urgent policy changes. Lancet 2007;369(9578):2042-9.

Getahun 2010

Getahun H, Gunneberg C, Granich R, Nunn P. HIV infection-associated tuberculosis: the epidemiology and the response. Clinical Infectious Diseases 2010;50(Suppl 3):201-7.

Global Laboratory Initiative 2017

Global Laboratory Initiative. Planning for country transition to Xpert® MTB/RIF Ultra cartridges. www.stoptb.org/wg/gli/assets/documents/gli_ultra.pdf (accessed 26 March 2020).

Global Laboratory Initiative 2019

Global Laboratory Initiative. Practical guide to implementing a quality assurance system for Xpert MTB/RIF testing. www.stoptb.org/wg/gli/assets/documents/Xpert-QA-guide-2019.pdf (accessed 7 January 2020).

Gopinath 2010

Gopinath K, Singh S. Non-tuberculous mycobacteria in TB-endemic countries: are we neglecting the danger? PLOS Neglected Tropical Diseases 2010;4(4):e615.

GRADEpro GDT [Computer program]

McMaster University (developed by Evidence Prime)GRADEpro GDT. Version accessed 29 October 2016. Hamilton (ON): McMaster University (developed by Evidence Prime). Available at gradepro.org.

Greenland 2016

Greenland S, Senn SJ, Rothman KJ, Carlin JB, Poole C, Goodman SN, et al. Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations. European Journal of Epidemiology 2016;31:337-50.

Gupta‐Wright 2018

Gupta-Wright A, Corbett EL, Van Oosterhout JJ, Wilson D, Grint D, Alufandika-Moyo M, et al. Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial. Lancet 2018;392(10144):292-301. [PMID: 30032978]

Hadgu 2005

Hadgu A, Dendukuri N, Hilden J. Evaluation of nucleic acid amplification tests in the absence of a perfect gold-standard test: a review of the statistical and epidemiologic issues. Epidemiology 2005;16(5):604–12.

Haraka 2018

Haraka F, Nathavitharana RR, Schumacher SG, Kakolwa M, Denkinger CM, Gagneux S, et al. Impact of diagnostic test Xpert MTB/RIF® on health outcomes for tuberculosis. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No: CD012972. [DOI: 10.1002/14651858.CD012972]

Hartmann 1967

Hartmann G, Honikel KO, Knüsel F, Nüesch J. The specific inhibition of the DNA-directed RNA synthesis by rifamycin. Biochimica et Biophysica Acta 1967;145(3):843-4.

Helb 2010

Helb D, Jones M, Story E, Boehme C, Wallace E, Ho K, et al. Rapid detection of Mycobacterium tuberculosis and rifampin resistance by use of on-demand, near-patient technology. Journal of Clinical Microbiology 2010;48(1):229-37.

Jiang 2020

Jiang J, Yang J, Shi Y, Jin Y, Tang S, Zhang N, et al. Head-to-head comparison of the diagnostic accuracy of Xpert MTB/RIF and Xpert MTB/RIF Ultra for tuberculosis: a meta-analysis. Infectious Diseases 2020;52(11):763-75.

Kay 2020

Kay AW, González Fernández L, Takwoingi Y, Eisenhut M, Vu RD, Steingart KR, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra assays for active tuberculosis and rifampicin resistance in children. Cochrane Database of Systematic Reviews 2020, Issue 8. Art. No: CD013359. [DOI: 10.1002/14651858.CD013359] [PMID: 32853411]

Kendall 2017

Kendall EA, Schumacher SG, Denkinger CM, Dowdy DW. Estimated clinical impact of the Xpert MTB/RIF Ultra cartridge for diagnosis of pulmonary tuberculosis: a modeling study. PLOS Medicine 2017;14(12):e1002472.

Kohli 2021

Kohli M, Schiller I, Dendukuri N, Yao M, Dheda K, Denkinger CM, et al. Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2021, Issue 1. Art. No: CD012768. [DOI: 10.1002/14651858.CD012768.pub3]

Leeflang 2013

Leeflang MM, Rutjes AW, Reitsma JB, Hooft L, Bossuyt PM. Variation of a test’s sensitivity and specificity with disease prevalence. Canadian Medical Association Journal 2013;185(11):E537–44. [DOI: 10.1503/cmaj.121286]

Lewinsohn 2017

Lewinsohn DM, Leonard MK, LoBue PA, Cohn DL, Daley CL, Desmond E, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of tuberculosis in adults and children. Clinical Infectious Diseases 2017;64(2):e1-33. [PMID: 27932390]

Lunn 2009

Lunn D, Spiegelhalter D, Thomas A, Best N. The BUGS project: evolution, critique, and future directions. Statistics in Medicine 2009;28(25):3049-67.

Macaskill 2010

Macaskill P, Gatsonis C, Deeks JJ, Harbord RM, Takwoingi Y. Chapter 10: Analysing and presenting results. In: Deeks JJ, Bossuyt PM, Gatsonis C, editor(s). Cochrane Handbook for Systematic Reviews of Diagnostic Test Accuracy Version 1.0. The Cochrane Collaboration, 2010. Available from srdta.cochrane.org.

McInnes 2018

McInnes MDF, Moher D, Thombs BD, McGrath TA, Bossuyt PM, PRISMA-DTA Group. Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: the PRISMA-DTA statement [published correction appears in JAMA. 2019 Nov 26;322(20):2026]. JAMA 2018;319(4):388-96. [DOI: 10.1001/jama.2017.19163]

Moher 2009

Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. PLOS Medicine 2009;6(7):e1000097. [DOI: 10.1371/journal.pmed1000097]

Nathavitharana 2017

Nathavitharana RR, Cudahy PG, Schumacher SG, Steingart KR, Pai M, Denkinger CM. Accuracy of line probe assays for the diagnosis of pulmonary and multidrug-resistant tuberculosis: a systematic review and meta-analysis. European Respiratory Journal 2017;49(1):1601075. [DOI: 10.1183/13993003.01075-2016]

Ngabonziza 2020

Ngabonziza JCS, Decroo T, Migambi P, Habimana YM, Van Deun A, Meehan CJ, et al. Prevalence and drivers of false-positive rifampicin-resistant Xpert MTB/RIF results: a prospective observational study in Rwanda. Lancet Microbe 2020;1(2):e74–83. [DOI: 10.1016/S2666-5247(20)30007-0]

Pai 2018

Pai M, Schumacher SG, Abimbola S. Surrogate endpoints in global health research: still searching for killer apps and silver bullets? BMJ Global Health 2018;3(2):e000755.

Perez‐Risco 2018

Perez-Risco D, Rodriguez-Temporal D, Valledor-Sanchez I, Alcaide F. Evaluation of the Xpert MTB/RIF Ultra assay for direct detection of Mycobacterium tuberculosis complex in smear-negative extrapulmonary samples. Journal of Clinical Microbiology 2018;56(9):e00659-18.

Perkins 2007

Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. Journal of Infectious Diseases 2007;196(Suppl 1):S15-27.

Peter 2016

Peter JG, Zijenah LS, Chanda D, Clowes P, Lesosky M, Gina P, et al. Effect on mortality of point-of-care, urine-based lipoarabinomannan testing to guide tuberculosis treatment initiation in HIV-positive hospital inpatients: a pragmatic, parallel-group, multicountry, open-label, randomised controlled trial. Lancet 2016;387(10024):1187-97. [PMID: 26970721]

R Core Team 2019 [Computer program]

R Foundation for Statistical ComputingR Core Team (2019). R: A language and environment for statistical computing. Vienna, Austria: R Foundation for Statistical Computing, 2019. Available at R-project.org.

Reitsma 2005

Reitsma JB, Glas AS, Rutjes AW, Scholten RJ, Bossuyt PM, Zwinderman AH. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. Journal of Clinical Epidemiology 2005;58(10):982-90.

Review Manager 2020 [Computer program]

Nordic Cochrane Centre, The Cochrane CollaborationReview Manager 5 (RevMan 5). Version 5.4. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2020.

Schumacher 2019

Schumacher SG, Denkinger CM. The impact of Xpert MTB/RIF - do we have a final answer? Lancet Global Health 2019;7(2):e161-2.

Schünemann 2008

Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ 2008;336(7653):1106-10.

Schünemann 2016

Schünemann HJ, Mustafa R, Brozek J, Santesso N, Alonso-Coello P, Guyatt G, et al, GRADE Working Group. GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. Journal of Clinical Epidemiology 2016;76:89-98. [DOI: 10.1016/j.jclinepi.2016.01.032]

Schünemann 2020a

Schünemann HJ, Mustafa R, Brozek J, Steingart KR, Leeflang M, Murad MH, et al. GRADE Guidelines: 21 part 1. Study design, risk of bias and indirectness in rating the certainty across a body of evidence for test accuracy. Journal of Clinical Epidemiology 2020;122:129-41. [DOI: 10.1016/j.jclinepi.2019.12.020]

Schünemann 2020b

Schünemann HJ, Mustafa R, Brozek J, Steingart KR, Leeflang M, Murad MH, et al. GRADE Guidelines: 21 part 2. Inconsistency, imprecision, publication bias and other domains for rating the certainty of evidence for test accuracy and presenting it in evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2020;122:142-52. [DOI: 10.1016/j.jclinepi.2019.12.021]

Shapiro 2020

Shapiro AE, Ross JM, Schiller I, Kohli M, Dendukuri N, Steingart KR, et al. Xpert MTB/RIF and Xpert Ultra assays for pulmonary tuberculosis and rifampicin resistance in adults irrespective of signs or symptoms of pulmonary tuberculosis. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No: CD013694. [DOI: 10.1002/14651858.CD013694]

Small 2011

Small PM, Pai M. Tuberculosis diagnosis - time for a game change. New England Journal of Medicine 2011;363(111):1070–1.

Stata 2017 [Computer program]

Stata. Version 15. College Station, TX, USA: StataCorp, 2017. Available at www.stata.com.

Steingart 2006a

Steingart KR, Henry M, Ng V, Hopewell PC, Ramsay A, Cunningham J, et al. Fluorescence versus conventional sputum smear microscopy for tuberculosis: a systematic review. Lancet Infectious Diseases 2006;6(9):570-81.

Steingart 2006b

Steingart KR, Ng V, Henry M, Hopewell PC, Ramsay A, Cunningham J, et al. Sputum processing methods to improve the sensitivity of smear microscopy for tuberculosis: a systematic review. Lancet Infectious Diseases 2006;6(10):664-74.

Steingart 2015

Steingart KR, Schiller I, Dendukuri N, Lalli M, Houben R, Churchyard G, et al. In reply to ‘False-positive Xpert® MTB/RIF assays in previously treated patients'. International Journal of Tuberculosis and Lung Disease 2015;19(3):366-7.

Takwoingi 2013

Takwoingi Y, Leeflang MM, Deeks JJ. Empirical evidence of the importance of comparative studies of diagnostic test accuracy. Annals of Internal Medicine 2013;158(7):544-54.

Telenti 1993

Telenti A, Imboden P, Marchesi F, Lowrie D, Cole S, Colston MJ, et al. Detection of rifampicin-resistance mutations in Mycobacterium tuberculosis . Lancet 1993;341(8846):647-50.

Theron 2014b

Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, et al. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet 2014;383(9915):424-35.

Unitaid 2017

Boyle D. Tuberculosis Diagnostics Technology and Market Landscape. 5th edition. Vernier: World Health Organization Unitaid Secretariat, 2017.

Vonasek 2020

Vonasek B, Ness T, Takwoingi Y, Kay AW, Wyk SS, Ouellette L, et al. Screening tests for active pulmonary tuberculosis in children. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No: CD013693. [DOI: 10.1002/14651858.CD013693]

Walzl 2018

Walzl G, McNerney R, Du Plessis N, Bates M, McHugh TD, Chegou NN, et al. Tuberculosis: advances and challenges in development of new diagnostics and biomarkers. Lancet Infectious Diseases 2018;18(7):e199-210.

Whiting 2011

Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine 2011;155(8):529-36.

WHO 2007

World Health Organization. Definition of a new sputum smear-positive TB case, 2007. who.int/tb/laboratory/policy_sputum_smearpositive_tb_case/en/index.html (accessed 10 December 2020).

WHO 2011a

World Health Organization. Rapid implementation of the Xpert MTB/RIF diagnostic test: technical and operational ‘how-to’; practical considerations; 2011. who.int/tb/publications/tb-amplificationtechnology-implementation/en/ (accessed 3 July 2020).

WHO 2011b

World Health Organization. Policy statement: automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system; 2011. ncbi.nlm.nih.gov/books/NBK304235/ (accessed 3 July 2020).

WHO 2013

World Health Organization. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system for the diagnosis of pulmonary and extrapulmonary TB in adults and children: policy update; 2013. apps.who.int/iris/handle/10665/112472 (accessed 3 July 2020).

WHO 2015a

World Health Organization. The END TB strategy; 2015. apps.who.int/iris/bitstream/handle/10665/331326/WHO-HTM-TB-2015.19-eng.pdf (accessed 29 March 2020).

WHO 2015b

World Health Organization. Implementing tuberculosis diagnostics: a policy framework; 2015. who.int/tb/publications/implementing_TB_diagnostics/en/ (accessed 3 July 2020).

WHO 2017

World Health Organization. WHO meeting report of a technical expert consultation: non-inferiority analysis of Xpert MTB/RIF Ultra compared to Xpert MTB/RIF; 2017. who.int/tb/publications/2017/XpertUltra/en/ (accessed 3 July 2020).

WHO 2021

World Health Organization. Technical report on critical concentrations for drug susceptibility testing of isoniazid and the rifamycins (rifampicin, rifabutin and rifapentine). Geneva: World Health Organization; 2021. www.who.int/publications/i/item/technical-report-on-critical-concentrations-for-drugsusceptibility-testing-of-isoniazid-and-therifamycins-(rifampicin-rifabutin-and-rifapentine) (accessed 13 February 2021).

WHO Consolidated Guidelines (Module 3) 2020

World Health Organization. WHO consolidated guidelines on tuberculosis. Module 3: diagnosis – rapid diagnostics for tuberculosis detection. Licence: CC BY-NC-SA 3.0 IGO. who.int/publications/i/item/who-consolidated-guidelines-on-tuberculosis-module-3-diagnosis---rapid-diagnostics-for-tuberculosis-detection (accessed 1 July 2020).

WHO Consolidated Guidelines (Module 4) 2020

World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment; June 2020. who.int/publications/i/item/9789240007048 (accessed 1 July 2020).

WHO Global tuberculosis report 2020

World Health Organization. Global tuberculosis report 2020. who.int/tb/publications/global_report/en/ (accessed 20 October 2020).

World Bank 2020

World Bank. World Bank List of Economies. datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups (accessed 30 March 2020).

Yang B 2020

Yang B, Whiting P, Davenport C, Deeks J, Hyde C, Mallett S, et al. Development of QUADAS-C, a risk of bias tool for comparative diagnostic accuracy studies. Available from osf.io/hq8mf (accessed 11 June 2020).

Zhang 2019

Zhang M, Xue M, He J. Diagnostic accuracy of the new Xpert MTB/RIF Ultra for tuberculosis disease: a preliminary systematic review and meta-analysis. International Journal of Infectious Diseases 2019;90:35-45.

References to other published versions of this review

Horne 2019

Horne DJ, Kohli M, Zifodya JS, Schiller I, Dendukuri N, Tollefson D, et al. Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2019, Issue 6. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593.pub4]

Sohn 2012

Sohn H, Pai M, Dendukuri N, Kloda LA, Boehme CC, Steingart KR. Xpert MTB/RIF test for detection of pulmonary tuberculosis and rifampicin resistance. Cochrane Database of Systematic Reviews 2012, Issue 1. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593]

Steingart 2013

Steingart KR, Sohn H, Schiller I, Kloda LA, Boehme CC, Pai M, et al. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593.pub2]

Steingart 2014

Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No: CD009593. [DOI: 10.1002/14651858.CD009593.pub3]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Berhanu 2018

Study characteristics

Patient Sampling

Cohort, all participants received Xpert MTB/RIF, and the order by which participants were selected to receive Xpert Ultra was randomized, prospective

Patient characteristics and setting

Presenting signs and symptoms: adults (18 years old) who presented with at least 1 TB symptom, which included cough of any duration, fever, weight loss, and night sweats
Age: median 36 years (range 18 to 77)

Sex, female: 33%

HIV infection: 62%

History of TB: 18%

Sample size: 237

Clinical setting: outpatient

Laboratory level: central

Country: South Africa

World Bank Income Classification: middle income

High TB burden country: yes

High MDR‐TB burden country: yes

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 27%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

LJ and MGIT; composite based on clinical and radiological findings

Rifampicin resistance

LJ, MGIT, MTBDRplus

Speciation: yes

Flow and timing

Comparative

Notes

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

Low concern

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Chakravorty 2017

Study characteristics

Patient Sampling

Cross‐sectional, manner of participant selection not reported, retrospective for FIND biobank specimens, prospective for clinical specimens; paired design, Xpert Ultra was tested retrospectively on a frozen aliquot of the fresh sputum specimen originally tested with Xpert MTB/RIF

Patient characteristics and setting

Presenting signs and symptoms: participants presenting with symptoms compatible with TB

Age: adult

Sex, female: not reported

HIV infection: not reported

History of TB: not reported

Sample size: 277

Clinical setting: not reported

Laboratory level: central

Country: FIND biobank frozen specimens (Peru, Vietnam, South Africa) and clinical specimens (Georgia, India)

World Bank Income Classification: middle and low

High TB burden country: yes

High MDR‐TB burden country: yes

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 72%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

LJ and MGIT (data provided based on MGIT)

Rifampicin resistance

LJ and MGIT

Speciation: yes

Flow and timing

Comparative

Notes

212 frozen specimens were included from FIND biobank. Ultra was tested retrospectively on a frozen aliquot of the same sputum sample tested with Xpert MTB/RIF (fresh sample).

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Unclear

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Unclear risk

Are there concerns that the included patients and setting do not match the review question?

Unclear

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Dorman 2018

Study characteristics

Patient Sampling

Cohort, consecutive enrolment, prospective data collection, multicentre study, paired design with Xpert Ultra and Xpert MTB/RIF tested on the same sputum sample

Patient characteristics and setting

Presenting signs and symptoms: presumed pulmonary TB

Age: adults, median 28 years (IQR 28 to 50)

Sex, female: 40%

HIV infection: 44%

History of TB: 21%

Sample size: 1439 for detection of Mycobacterium tuberculosis, 551 for rifampicin resistance

Clinical setting: both outpatient and inpatient

Laboratory level: central (reference)

Country: Belarus, Brazil, China, Georgia, India, Kenya, South Africa, Uganda

World Bank Income Classification: low and middle income

High TB burden country: yes (Brazil, China, India, Kenya, South Africa)

High MDR‐TB burden country: yes (Belarus, China, India, Kenya, South Africa)

High TB/HIV burden country: yes (Brazil, China, India, Kenya, South Africa, Uganda)

Prevalence of TB cases in the study: 32%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

LJ and MGIT

Rifampicin resistance

MGIT

Speciation: yes

Flow and timing

Comparative

Notes

25 participants (3%) who were smear‐positive but in whom all cultures were negative were excluded from the analysis.

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

Low concern

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Unclear

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

No

Could the patient flow have introduced bias?

Low risk

Mishra 2020a

Study characteristics

Patient Sampling

Cohort, consecutive, prospective. Paired design; collected 3 sputum samples from each patient, 2 at the first visit, of which 1 was tested using Xpert and the other was tested using culture, and 1 sample the next morning, which was tested using Ultra

Patient characteristics and setting

Presenting signs and symptoms: presumptive pulmonary TB according to the WHO

Age: ≥ 18 years; median 37 years (IQR 27 to 50)

Sex, female: 49%

HIV infection: 20%

History of TB: 39%

Sample size: 239

Clinical setting: outpatient

Laboratory level: central

Country: South Africa

World Bank Income Classification: middle income

High TB burden country: yes

High MDR‐TB burden country: yes

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 30%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

MGIT

Rifampicin resistance

MTBDRplus

Speciation: yes

Flow and timing

Comparative

Notes

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

Low concern

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Mishra 2020b

Study characteristics

Patient Sampling

Cross‐sectional, random selection (1:1 testing Xpert Ultra or Xpert MTB/RIF), prospective

Patient characteristics and setting

Presenting signs and symptoms: preselected for recent (< 2 years) previous TB treatment

Age: ≥ 18 years; median 37.5 (30 to 50)

Sex, female: 40%

HIV infection: 44%

History of TB: 100%

Sample size: 346

Clinical setting: unknown

Laboratory level: central

Country: South Africa

World Bank Income Classification: middle income

High TB burden country: yes

High MDR‐TB burden country: yes

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 26%

Index tests

Xpert MTB/RIF OR Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

MGIT

Rifampicin resistance

MTBDRplus

Speciation: yes

Flow and timing

Of 124 participants tested with Xpert Ultra, 18 were rifampicin resistant indeterminate; of 127 participants tested with Xpert MTB/RIF, only 1 participant was rifampicin resistant indeterminate.

Comparative

Notes

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

No

Could the selection of patients have introduced bias?

High risk

Are there concerns that the included patients and setting do not match the review question?

Unclear

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Opota 2019

Study characteristics

Patient Sampling

Cross‐sectional, consecutive, prospective and retrospective; Xpert MTB/RIF assay was tested on some fresh and some frozen specimens, whereas Xpert Ultra was performed only on frozen specimens paired with Xpert MTB/RIF

Patient characteristics and setting

Presenting signs and symptoms: suspected pulmonary tuberculosis

Age: unknown

Sex, female: not reported

HIV infection: not reported

History of TB: not reported

Sample size: 196

Clinical setting: laboratory‐based evaluation in a hospital using the index test for decisions regarding the need for airborne isolation

Laboratory level: central

Country: Switzerland

World Bank Income Classification: high

High TB burden country: no

High MDR‐TB burden country: no

High TB/HIV burden country: no

Prevalence of TB cases in the study: 24%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

MGIT; composite based on clinical, X‐ray, and other methods

Rifampicin resistance

MGIT

Speciation: not reported

Flow and timing

Comparative

Notes

Study included 69 frozen specimens. When considering the 47 culture‐positive specimens, all of the isolates were phenotypically susceptible to rifampicin.

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

High

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Unclear

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Pereira 2020

Study characteristics

Patient Sampling

Cross‐sectional, consecutive, prospective; paired design, all samples were tested with Xpert Ultra and Xpert MTB/RIF

Patient characteristics and setting

Presenting signs and symptoms: respiratory symptoms suggestive of pulmonary tuberculosis, such as productive cough for > 2 weeks, cough of any duration accompanied by constitutional symptoms (fever for at least 3 days, night sweats or weight loss of at least 3 kg in the previous month), or haemoptysis

Age: > 18 years; mean 50 years (SD 18)

Sex, female: 44%

HIV infection: 2%

History of TB: 0%

Sample size: 180

Clinical setting: outpatient

Laboratory level: intermediate

Country: Brazil

World Bank Income Classification: middle income

High TB burden country: yes

High MDR‐TB burden country: no

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 13%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

Ogawa‐Kudoh method

Speciation: not reported

Flow and timing

Comparative

Notes

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

Low concern

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Unclear

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Could the reference standard, its conduct, or its interpretation have introduced bias?

Unclear risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Unclear

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Piersimoni 2019

Study characteristics

Patient Sampling

Cross‐sectional, consecutive, retrospective, frozen specimens; paired design, Xpert Ultra was tested on a frozen aliquot of the fresh sputum specimen originally tested with Xpert MTB/RIF

Patient characteristics and setting

Presenting signs and symptoms: patients presenting with tuberculosis symptoms and abnormal X‐ray imaging

Age: median 42 years (range 7 to 91, with only 2/254 participants below 15 years)

Sex, female: 37%

HIV infection: not reported

History of TB: excluded from study

Sample size: 266

Clinical setting: tertiary hospital (majority were inpatients, < 10% outpatients)

Laboratory level: central

Country: Italy

World Bank Income Classification: high

High TB burden country: no

High MDR‐TB burden country: no

High TB/HIV burden country: no

Prevalence of TB cases in the study: 46%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

MGIT

Rifampicin resistance

MGIT

Speciation: yes

Flow and timing

Comparative

Notes

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

Yes

Could the selection of patients have introduced bias?

Low risk

Are there concerns that the included patients and setting do not match the review question?

High

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Yes

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Yes

Could the reference standard, its conduct, or its interpretation have introduced bias?

Low risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Wang 2019

Study characteristics

Patient Sampling

Cohort, consecutive, prospective; paired design, Xpert Ultra assay was tested on frozen specimens and Xpert MTB/RIF on fresh specimens

Patient characteristics and setting

Presenting signs and symptoms: patients with tuberculosis symptoms suspected of having pulmonary tuberculosis, smear‐negative

Age: median 47 years (range 14 to 89), smear‐negative pulmonary tuberculosis

Sex, female: 34%

HIV infection: 0%

History of TB: 50%

Sample size: 498

Clinical setting: national‐level tuberculosis referral centre, inpatients

Laboratory level: central

Country: China

World Bank Income Classification: middle income

High TB burden country: yes

High MDR‐TB burden country: yes

High TB/HIV burden country: yes

Prevalence of TB cases in the study: 24%

Index tests

Xpert MTB/RIF and Xpert Ultra

Target condition and reference standard(s)

Pulmonary tuberculosis

LJ and MGIT

Rifampicin resistance

LJ

Speciation: yes

Flow and timing

Comparative

Notes

Xpert Ultra was tested using specimens stored at −80 °C.

Methodological quality

Item

Authors' judgement

Risk of bias

Applicability concerns

DOMAIN 1: Patient Selection

Was a consecutive or random sample of patients enrolled?

Yes

Was a case‐control design avoided?

Yes

Did the study avoid inappropriate exclusions?

No

Could the selection of patients have introduced bias?

High risk

Are there concerns that the included patients and setting do not match the review question?

High

DOMAIN 2: Index Test (Xpert MTB/RIF)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 2: Index Test (Xpert Ultra)

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes

If a threshold was used, was it pre‐specified?

Yes

Could the conduct or interpretation of the index test have introduced bias?

Low risk

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

Low concern

DOMAIN 3: Reference Standard

Is the reference standards likely to correctly classify the target condition?

Yes

Were the reference standard results for TB detection interpreted without knowledge of the results of the index test?

Unclear

Were the reference standard results for rifampicin resistance detection interpreted without knowledge of the results of the index test?

Unclear

Could the reference standard, its conduct, or its interpretation have introduced bias?

Unclear risk

Are there concerns that the target condition as defined by the reference standard does not match the question?

Low concern

DOMAIN 4: Flow and Timing

Was there an appropriate interval between index test and reference standard?

Yes

Did all patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Could the patient flow have introduced bias?

Low risk

Abbreviations: ICU: intensive care unit; IQR: interquartile range; LJ: Löwenstein–Jensen; MDR‐TB: multidrug‐resistant TB; MGIT: Mycobacteria Growth Indicator Tube; MODS: microscopic observation drug susceptibility; SD: standard deviation; TB: tuberculosis; WHO: World Health Organization

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Abong 2019

Xpert Ultra not evaluated

Acuna‐Villaorduna 2017

Duplicate data with additional analyses; Boum 2016 includes same data set

Ade 2016

Includes both adults and children, or no information about age of enrolment

Adelman 2014

Abstract

Afshan 2019

Xpert Ultra not evaluated

Agizew 2017

Data insufficient for 2 x 2 table

Agizew 2019

Xpert Ultra not evaluated

Agrawal 2016

Includes both adults and children, or no information about age of enrolment

Agustina 2019

Paediatric population

Ai 2019

Xpert Ultra not evaluated

Akhter 2019

Xpert Ultra not evaluated

Alame‐Emane 2017

Data insufficient for 2 x 2 table

Al‐Ateah 2012

Includes both adults and children, or no information about age of enrolment

Albay 2016

Includes both adults and children, or no information about age of enrolment

Al‐Darraji 2016

Data insufficient for 2 x 2 table

Allahyartorkaman 2019

Xpert Ultra not evaluated

Alland 2015

Abstract

Alnimr 2014

Data insufficient for 2 x 2 table

Alvarez 2015

Includes both adults and children, or no information about age

Alvarez‐Uria 2012

Reference standard not satisfied

Alvis‐Zakzuk 2017

Systematic review

Andriani 2016

Abstract

Antonenka 2013

Case‐control study

Ardizzoni 2019

Xpert Ultra not evaluated

Aricha 2019

Xpert Ultra not evaluated

Armand 2011

This was a case‐control study that compared Xpert MTB/RIF with an in‐house IS6110‐based real‐time PCR using TaqMan probes (IS6110‐TaqMan assay) for TB detection.

Asencio 2013

Cost‐effectiveness study

Aston 2016

Abstract

Atashi 2017

Data insufficient for 2 x 2 table

Atehortua 2015

Includes both adults and children, or no information about age of enrolment

Atuhumuza 2016

Abstract

Atwine 2015

Data insufficient for 2 x 2 table

Auld 2016

Includes both adults and children

Aurin 2014

Includes both adults and children, or no information about age of enrolment

Avashia 2016

Reference standard not satisfied

Ayala 2016

Data insufficient for 2 x 2 table

Aydemir 2019

Xpert Ultra not evaluated

Bablishvili 2015

Includes both adults and children, or no information about age of enrolment

Badal‐Faesen 2017

Duplicate data with additional analyses; Luetkemeyer 2016 includes same data set

Baikunje 2019

Xpert Ultra not evaluated

Bajrami 2016

Includes data for pulmonary and extrapulmonary TB combined

Balcha 2014

Xpert was not the index test.

Banu 2014

Data insufficient for 2 x 2 table

Barcellini 2019

Community‐based screening

Barkham 2016

Abstract

Barnard 2012

Includes both adults and children, or no information about age of enrolment

Bates 2013

This study evaluated Xpert MTB/RIF for the diagnosis of TB in children.

Benjamin 2019

Xpert Ultra not evaluated

Bhardwaj 2019

Xpert Ultra not evaluated

Biadglegne 2014

Includes both adults and children, or no information about age of enrolment

Bilgin 2016

Includes both adults and children, or no information about age of enrolment

Bimba 2019

Xpert Ultra not evaluated

Bisognin 2018

Not a diagnostic accuracy study

Bjerrum 2015

Xpert was not the index test.

Boakye‐Appiah 2016

Data insufficient for 2 x 2 table

Bojang 2016

Xpert was not the index test.

Bonnet 2017

Data insufficient for 2 x 2 table

Borodulina 2019

Xpert Ultra not evaluated

Boum 2016

Xpert Ultra not evaluated

Bowles 2011

Includes both adults and children, or no information about age of enrolment

Bunsow 2014

Includes respiratory specimens and gastric aspirates

Byashalira 2019

Xpert Ultra not evaluated

Capocci 2016

Abstract

Causse 2011

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Cavanaugh 2016

Data insufficient for 2 x 2 table

Cayci 2017

Includes both adults and children, or no information about age of enrolment

Celik 2015

Includes both adults and children, or no information about age of enrolment

Chakraborty 2019

Xpert Ultra not evaluated

Chhajed 2019

Xpert Ultra not evaluated

Chishty 2016

Abstract

Ciftçi 2011

Includes both adults and children, or no information about age of enrolment

Clouse 2012

Study on patient impact

Cross 2014

Reference standard not satisfied

Cross 2015

Includes both adults and children, or no information about age of enrolment

Dagnra 2015

Data insufficient for 2 x 2 table

Dahale 2019

Xpert Ultra not evaluated

Daum 2015

Xpert not the index test

Deggim 2013

Includes both adults and children, or no information about age of enrolment

Dierberg 2016

Data insufficient for 2 x 2 table

Dorjee 2012

Case report

Dorman 2012

Prevalence survey

Dowdy 2011

Cost‐effectiveness study

Eldin 2019

Xpert Ultra not evaluated

Elzein 2019

Xpert Ultra not evaluated

Fantahun 2019

Xpert Ultra not evaluated

Feasey 2013

Data insufficient for 2 x 2 table

Fernandez 2017

Abstract

FIND 2011

This study compared Xpert MTB/RIF G3 and G4. We excluded it owing to concerns about duplicate data. In addition, the criteria for the reference standard for rifampicin resistance detection were not satisfied.

Fong 2017

Abstract

Friedrich 2011

This study evaluated Xpert MTB/RIF for the diagnosis of pleural TB.

Gama de Andrade 2017

Abstract

Garcia‐Basteiro 2019

Inappropriate reference standard

Gati 2018

Xpert Ultra not evaluated

Gelalcha 2017

Includes both adults and children, or no information about age of enrolment

Gounder 2014

Includes both adults and children, or no information about age of enrolment

Griesel 2016

Abstract

Griesel 2017

Includes data for pulmonary and extrapulmonary TB combined

Guenaoui 2016

Includes both adults and children, or no information about age of enrolment

Gupta 2014

Abstract

Gurbanova 2016

Abstract

Gurbanova 2017

Includes data for pulmonary and extrapulmonary TB combined

Gursoy 2016

Includes both adults and children, or no information about age of enrolment

Habeenzu 2017

Includes both adults and children, or no information about age of enrolment

Hai 2019

Xpert Ultra not evaluated

Hanifa 2016

Reference standard not satisfied

Heidebrecht 2016

Data insufficient for 2 x 2 table

Hillemann 2011

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Hiza 2017

Not a diagnostic accuracy study

Ho 2016

Community‐based screening

Hodille 2019

Only culture‐positive specimens were tested; Xpert MTB/RIF was not evaluated.

Horo 2017

Includes both adults and children, or no information about age of enrolment

Hu 2014

Includes both adults and children, or no information about age of enrolment

Huang 2018

Includes both adults and children, or no information about age of enrolment

Huerga 2017

Xpert was not the index test.

Ioannidis 2010

We could not obtain this article.

Ioannidis 2011

Includes both adults and children, or no information about age of enrolment

Iram 2015

Includes both adults and children, or no information about age of enrolment

Jafari 2013

Data insufficient for 2 x 2 table

Jin 2019

Xpert Ultra not evaluated

Jing 2017

Includes both adults and children, or no information about age of enrolment

Jipa 2016

Abstract

Jones‐Lopez 2014

Xpert was not the index test.

Kang 2016

Abstract

Kaur 2016

Systematic review

Kayigire 2013

Not a diagnostic accuracy study

Kazemian 2019

Xpert Ultra not evaluated

Kelly‐Cirino 2017

Xpert was not the index test.

Kendall 2019

Case‐control study

Kerkhoff 2013

Data insufficient for 2 x 2 table

Kerkhoff 2014

Data insufficient for 2 x 2 table

Khadka 2019

Xpert Ultra not evaluated

Khalil 2015

Includes both adults and children, or no information about age of enrolment

Khan 2016

Data insufficient for 2 x 2 table

Kim 2012

Case‐control study

Kim CH 2014

Duplicate data; Kim CH 2015 includes the same data with more participants

Kim CH 2015

Xpert Ultra not evaluated

Kim MJ 2015

Data insufficient for 2 x 2 table

Kim YW 2015

Includes both adults and children, or no information about age of enrolment

Kolia‐Diafouka 2019

Case‐control study

Lange 2017

Systematic review

Laskar 2017

Could not obtain full text

Lawn 2012a

Study on patient impact

Lawn 2012b

Data insufficient for 2 x 2 table

Lawn 2012c

Primarily a lipoarabinomannan detection study

Lawn 2013

Data insufficient for 2 x 2 table

Lawn 2015

Reference standard not satisfied

Lawn 2017

Reference standard not satisfied

Lebina 2016

Community‐based screening

Lessells 2017

Impact study

Li 2016

Includes both adults and children, or no information about age of enrolment

Li 2017

Systematic review

Li 2020

Xpert Ultra not evaluated

Ligthelm 2011

This study evaluated Xpert MTB/RIF for the diagnosis of TB lymphadenitis.

Lombardi 2017

Includes both adults and children, or no information about age of enrolment

Luetkemeyer 2016

Xpert Ultra not evaluated

Mafort 2017

Abstract

Malbruny 2011

Includes both adults and children, or no information about age of enrolment

Marlowe 2011

Includes both adults and children, or no information about age of enrolment

Matabane 2015

Includes both adults and children, or no information about age of enrolment

Mave 2017

Screening

Maynard‐Smith 2014

Systematic review

Mechal 2019

Xpert Ultra not evaluated

Miller 2011

Includes both adults and children, or no information about age of enrolment

Miotto 2012

Treatment monitoring

Mntonintshi 2017

Data insufficient for 2 x 2 table

Modi 2016

Xpert was not the index test.

Mokaddas 2016

Abstract

More 2017

Data insufficient for 2 x 2 table

Morozova 2016

Abstract

Moure 2012

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Mukherjee 2017

Reference standard not satisfied

Mulder 2017

Xpert was not the index test.

Muñoz 2013

Study on patient impact

Myneedu 2014

Includes both adults and children, or no information about age of enrolment

Naidoo 2016

Data insufficient for 2 x 2 table

Narasimooloo 2012

Study on patient impact

Ng 2018

Case‐control study

Nguyen 2018

Includes both adults and children, or no information about age of enrolment

Ngwira 2017

Abstract

Nhu 2013

This study evaluated Xpert MTB/RIF for the diagnosis of TB in children.

Nicol 2011

This study evaluated Xpert for the diagnosis of TB in children.

Ninan 2016

Xpert was not the index test.

Nosova 2013a

Duplicate data; same study as Nosova 2013b. Nosova 2013a is written in Russian.

Nosova 2013b

Xpert Ultra not evaluated

Ntinginya 2012

Active case finding, not a diagnostic test accuracy study

O'Grady 2012

This study evaluated Xpert MTB/RIF in patients able to produce sputum, irrespective of admission diagnosis, not presumed TB patients.

Oliveira 2019

Xpert Ultra not evaluated

Omar 2019

Xpert Ultra not evaluated

Omrani 2014

Not a diagnostic accuracy study

Opota 2016

Includes both adults and children, or no information about age of enrolment

Osman 2014

Case‐control study

Ou 2015

Includes both adults and children, or no information about age of enrolment

Ozkutuk 2014

Includes both adults and children, or no information about age of enrolment

Pandey P 2017

Includes both adults and children, or no information about age of enrolment

Pandey S 2017

Includes both adults and children, or no information about age of enrolment

Parcell 2017

Includes both adults and children, or no information about age of enrolment

Patel 2020

Xpert Ultra not evaluated

Patil 2014

Case report

Patil 2017

Reference standard not satisfied

Peter 2012

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Peter 2013

Data insufficient for 2 x 2 table

Peter 2015

Duplicate data; study was nested in Theron 2014b

Qureshi 2019

Xpert Ultra not evaluated

Rachow 2012

This study evaluated Xpert for the diagnosis of TB in children.

Rahman 2016

Not a diagnostic accuracy study

Raizada 2015

Not a diagnostic accuracy study

Ramamurthy 2016

Data insufficient for 2 x 2 table

Ramirez 2014

Not a diagnostic accuracy study

Rasheed 2019

Xpert Ultra not evaluated

Rathish 2019

Xpert Ultra not evaluated

Rathour 2019

Xpert Ultra not evaluated

Reechaipichitkul 2016

Duplicate data; more participants were included in Reechaipichitkul 2017

Reechaipichitkul 2017

Xpert Ultra not evaluated

Reed 2016

Xpert was not the index test.

Rees 2018

Impact study

Reis 2019

Xpert Ultra not evaluated

Rivera 2019

Xpert Ultra not evaluated

Rossato 2018

Study design unclear, possibly case‐control

Rufai 2014

Data insufficient for 2 x 2 table

Ruiz 2017

Xpert was not the index test.

Sachdeva 2015

Not a diagnostic accuracy study

Saeed 2017

Data insufficient for 2 x 2 table

Sanchez‐Padilla 2015

Not a diagnostic accuracy study

Sauzullo 2016

Includes both adults and children, or no information about age of enrolment

Schutz 2019

Xpert Ultra not evaluated

Set 2019

Xpert Ultra not evaluated

Shah 2014

Case‐control study

Shah 2020

Xpert Ultra not evaluated

Sharma 2019

Did not include specimen of choice

Shenai 2013

Data insufficient for 2 x 2 table

Shenoy 2019

Xpert Ultra not evaluated

Shilpa 2017

Reference standard not satisfied

Simone 2019

Xpert Ultra not evaluated

Singh 2019

Xpert Ultra not evaluated

Smith 2014

Not a diagnostic accuracy study

Somashekar 2014

Reference standard not satisfied

Somily 2016

Includes both pulmonary and extrapulmonary specimens combined

Strydom 2015

Case‐control study

Sumalani 2019

Xpert Ultra not evaluated

Sumayya 2019

Xpert Ultra not evaluated

Sun 2019

Paediatric population

Sureshbabu 2016

Reference standard not satisfied

Tadesse 2016

Abstract

Tahseen 2016

Drug resistance survey

Tahseen 2019

Xpert Ultra not evaluated

Talib 2019

Xpert Ultra not evaluated

Tan 2017

Xpert was not the index test.

Taylor 2012

This study evaluated Xpert for the diagnosis of extrapulmonary TB.

Teo 2011

Includes both adults and children, or no information about age of enrolment

Theron 2012

Treatment monitoring

Theron 2014a

Duplicate data set for Theron 2014a with a different aim

Theron 2016

Duplicate data. Author reported that this study overlaps with Theron 2014a and can be excluded.

Theron 2018

Screening study

Thibbadee 2016

Abstract

Thit 2017

Xpert was not the index test.

To 2017

Abstract

Tortoli 2012

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Uddin 2019

Xpert Ultra not evaluated

Udgirkar 2019

Xpert Ultra not evaluated

Ullah 2016

Includes both adults and children, or no information about age of enrolment

Ullah 2017

Includes both adults and children, or no information about age of enrolment

Vadwai 2011

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Van Kampen 2015

Includes both adults and children, or no information about age of enrolment

Van Rie 2011

Case report

Walters 2012

This study evaluated Xpert MTB/RIF for the diagnosis of TB in children.

Walusimbi 2013

Systematic review

Wang 2015

Systematic review

Wang 2016

Includes both adults and children, or no information about age of enrolment

Williamson 2012

Case‐control study

Wood 2012

This study evaluated Xpert MTB/RIF for the diagnosis of extrapulmonary TB.

Xie 2017

Xpert was not the index test.

Yadav 2017

Includes both adults and children, or no information about age of enrolment

Yan 2016

Systematic review

Yang X 2020

Xpert Ultra not evaluated

Yeong 2019

Xpert Ultra not evaluated

Yu 2020

Xpert Ultra not evaluated

Zar 2012

This study evaluated Xpert MTB/RIF for the diagnosis of TB in children.

Zar 2019

This study evaluated Xpert MTB/RIF for the diagnosis of TB in children.

Zemlyansky 2016

Includes both adults and children, or no information about age of enrolment

Zhou 2020

Xpert Ultra not evaluated

Zimba 2019

Xpert Ultra not evaluated

Zurcher 2019

Xpert Ultra not evaluated

PCR: polymerase chain reaction; TB: tuberculosis

Characteristics of ongoing studies [ordered by study ID]

ChiCTR180001479

Study name

Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV‐infected adults: a prospective cohort study

Target condition and reference standard(s)

Tuberculosis, HIV/AIDS

Index and comparator tests

Index test is Xpert MTB/RIF Ultra on bronchoalveolar lavage fluid in HIV‐positive patients. Comparator tests will include Xpert MTB/RIF and culture.

Starting date

5 February 2018

Contact information

Yang Zhou; [email protected]

Notes

Chictr.org.cn Identifier: ChiCTR1800014792

ChiCTR1800014792

Study name

Diagnostic accuracy of Xpert MTB/RIF Ultra for tuberculous bronchoalveolar lavage fluid in HIV‐infected adults: a prospective cohort study

Target condition and reference standard(s)

Tuberculosis and HIV/AIDS, MGIT (Mycobacteria Growth Indicator Tube)

Index and comparator tests

Xpert Ultra

Starting date

12 February 2018

Contact information

Peize Zhang; [email protected]

Notes

WHO ICTRP: ChiCTR1800014792

ChiCTR1900026491

Study name

The diagnostic value of medical thoracoscopy combined with Xpert MTB/RIF Ultra in smear and culture negative pulmonary tuberculosis

Target condition and reference standard(s)

Tuberculosis (smear and culture negative)

Index and comparator tests

Index tests are Xpert MTB/RIF Ultra and thoracoscopy with comparator of pathologic diagnosis in smear and culture‐negative pulmonary tuberculosis.

Starting date

12 October 2019

Contact information

Hairong Huang; [email protected]

Notes

Chictr.org.cn Identifier: ChiCTR1900026491

ISRCTN77241966

Study name

Evaluation of GeneXpert Ultra and digital chest radiography for diagnosing tuberculosis

Target condition and reference standard(s)

Tuberculosis, HIV/AIDS

Index and comparator tests

Index test is Xpert Ultra with comparator of Xpert or microscopy (current standard of care), with reference standard of bacteriologically confirmed TB.

Starting date

9 February 2019

Contact information

Dr Marriot Nliwasa; [email protected]

Notes

Isrctn.com Identifier: ISRCTN77241966

NCT03154320

Study name

A trial of same‐day testing and treatment to improve outcomes among symptomatic patients newly diagnosed with HIV

Target condition and reference standard(s)

Tuberculosis, HIV/AIDS

Index and comparator tests

Spot and early‐morning Xpert Ultra results and chest X‐ray, as single and as combined tests, with liquid culture as reference standard

Starting date

16 May 2017

Contact information

Serena P Koenig, MD; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT03154320

NCT03187964

Study name

Xpert Ultra and Xpert HIV‐VL in people living with HIV (UltraHIV)

Target condition and reference standard(s)

Tuberculosis, HIV/AIDS

Index and comparator tests

Impact study

Starting date

15 June 2017

Contact information

Grant Theron, PhD; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT03187964

NCT03356925

Study name

Improving tuberculosis diagnosis and treatment through Basic, Applied and health systems Research (BAR)

Target condition and reference standard(s)

Tuberculosis

Index and comparator tests

Xpert Ultra point‐of‐care testing compared to the standard‐of‐care tuberculosis testing at a centralized facility

Starting date

29 November 2017

Contact information

Grant Theron, PhD; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT03356925

NCT03497195

Study name

Achieving tuberculosis control in Zambia

Target condition and reference standard(s)

Tuberculosis

Index and comparator tests

Comparison of 2 diagnostic tools (chest X‐ray with computer‐assisted diagnosis versus C‐reactive protein) and Xpert Ultra for active community‐based tuberculosis case detection

Starting date

13 April 2018

Contact information

Stewart Reid, MD, MPH; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT03497195

NCT03712709

Study name

Xpert MTB/XDR Clinical Evaluation Trial

Target condition and reference standard(s)

Tuberculosis, MDR‐TB, Xpert MTB/XDR

Index and comparator tests

Index test is Xpert MTB/XDR, with comparators of Xpert MTB/RIF or Ultra.

Starting date

2 November 2018

Contact information

Adam Penn‐Nicholson, PhD; adam.penn‐[email protected]

Notes

ClinicalTrials.gov Identifier: NCT03728725

NCT04074369

Study name

Evaluation of CRISPR‐based test for the rapid identification of TB in pulmonary tuberculosis suspects

Target condition and reference standard(s)

Tuberculosis, CRISPR

Index and comparator tests

Index test is CRISPR, with reference standard and comparators to include Xpert MTB/RIF, clinical diagnosis, and culture.

Starting date

30 August 2019

Contact information

Wenhong Zhang; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT04074369

NCT04122404

Study name

POC Strategies to Improve TB Care in Advanced HIV Disease (TBPOC)

Target condition and reference standard(s)

Tuberculosis, HIV/AIDS

Index and comparator tests

Index test is Lateral flow urine lipoarabinomannan (LF‐LAM), with comparators including sputum smear microscopy, Xpert MTB/RIF and Xpert MTB/RIF Ultra, and sputum culture.

Starting date

10 October 2019

Contact information

Johanna Maria Åhsberg, MD; [email protected]

Notes

ClinicalTrials.gov Identifier: NCT04122404

NCT058236

Study name

Tuberculosis Research of INA‐RESPOND On Drug Resistance (TRIPOD)

Target condition and reference standard(s)

Tuberculosis

Index and comparator tests

Index test is Xpert MTB/RIF and acid‐fast bacilli (AFB) smear as compared to sputum culture. Will also evaluate clinical diagnosis as compared to sputum culture.

Starting date

5 May 2016

Contact information

Erlina Burhan, SpP(K), MSc

Notes

ClinicalTrials.gov Identifier: NCT02758236

Data

Presented below are all the data for all of the tests entered into the review.

Open in table viewer
Tests. Data tables by test

Test

No. of studies

No. of participants

1 Xpert Ultra for detection of pulmonary TB Show forest plot

9

3500


Xpert Ultra for detection of pulmonary TB

Xpert Ultra for detection of pulmonary TB

2 Xpert MTB/RIF for detection of pulmonary TB Show forest plot

7

2835


Xpert MTB/RIF for detection of pulmonary TB

Xpert MTB/RIF for detection of pulmonary TB

3 Xpert Ultra for detection of pulmonary TB, composite reference standard Show forest plot

2

433


Xpert Ultra for detection of pulmonary TB, composite reference standard

Xpert Ultra for detection of pulmonary TB, composite reference standard

4 Xpert MTB/RIF for detection of pulmonary TB, composite reference standard Show forest plot

2

433


Xpert MTB/RIF for detection of pulmonary TB, composite reference standard

Xpert MTB/RIF for detection of pulmonary TB, composite reference standard

5 Smear‐negative, Xpert Ultra, culture Show forest plot

7

2547


Smear‐negative, Xpert Ultra, culture

Smear‐negative, Xpert Ultra, culture

6 Smear‐negative, Xpert MTB/RIF, culture Show forest plot

7

2549


Smear‐negative, Xpert MTB/RIF, culture

Smear‐negative, Xpert MTB/RIF, culture

7 Smear‐positive, Xpert Ultra Show forest plot

6

593


Smear‐positive, Xpert Ultra

Smear‐positive, Xpert Ultra

8 Smear‐positive, Xpert MTB/RIF Show forest plot

6

598


Smear‐positive, Xpert MTB/RIF

Smear‐positive, Xpert MTB/RIF

9 HIV‐positive, Xpert Ultra Show forest plot

3

627


HIV‐positive, Xpert Ultra

HIV‐positive, Xpert Ultra

10 HIV‐positive, Xpert MTB/RIF Show forest plot

3

635


HIV‐positive, Xpert MTB/RIF

HIV‐positive, Xpert MTB/RIF

11 HIV‐negative, Xpert Ultra Show forest plot

3

755


HIV‐negative, Xpert Ultra

HIV‐negative, Xpert Ultra

12 HIV‐negative, Xpert MTB/RIF Show forest plot

3

755


HIV‐negative, Xpert MTB/RIF

HIV‐negative, Xpert MTB/RIF

13 Xpert Ultra, history of TB Show forest plot

4

602


Xpert Ultra, history of TB

Xpert Ultra, history of TB

14 Xpert Ultra, no history of TB Show forest plot

3

1476


Xpert Ultra, no history of TB

Xpert Ultra, no history of TB

15 Xpert MTB/RIF, history of TB Show forest plot

4

610


Xpert MTB/RIF, history of TB

Xpert MTB/RIF, history of TB

16 Xpert MTB/RIF, no history of TB Show forest plot

3

1476


Xpert MTB/RIF, no history of TB

Xpert MTB/RIF, no history of TB

17 Xpert Ultra for detection of rifampicin resistance Show forest plot

5

921


Xpert Ultra for detection of rifampicin resistance

Xpert Ultra for detection of rifampicin resistance

18 Xpert MTB/RIF for detection of rifampicin resistance Show forest plot

5

930


Xpert MTB/RIF for detection of rifampicin resistance

Xpert MTB/RIF for detection of rifampicin resistance

19 Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard Show forest plot

3

40


Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard

Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard

20 Xpert Ultra for detection of rifampicin resistance, smear‐positive Show forest plot

4

686


Xpert Ultra for detection of rifampicin resistance, smear‐positive

Xpert Ultra for detection of rifampicin resistance, smear‐positive

21 Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive Show forest plot

4

699


Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive

Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive

22 Xpert Ultra for detection of rifampicin resistance, smear‐negative Show forest plot

4

412


Xpert Ultra for detection of rifampicin resistance, smear‐negative

Xpert Ultra for detection of rifampicin resistance, smear‐negative

23 Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative Show forest plot

4

416


Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative

Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative

The clinical pathway describes how people might present and the point in the pathway at which they would be considered for testing with Xpert MTB/RIF or Xpert Ultra.Abbreviations: DST: drug susceptibility testing; INH: isoniazid; MDR‐TB: multidrug‐resistant tuberculosis; MTB: Mycobacterium tuberculosis; mWRD: molecular WHO‐recommended rapid diagnostic; PLHIV: people living with HIV; RIF: rifampicin; TB: tuberculosis; Ultra: Xpert Ultra; WHO: World Health Organization.1Persons to be evaluated for TB include adults and children with signs or symptoms suggestive of TB, or with a chest X‐ray with abnormalities suggestive of TB. This algorithm may also be followed for the diagnosis of extrapulmonary TB using CSF, lymph node and other tissue specimens.
2Programs may consider collecting two specimens upfront. The first specimen should be promptly tested using the molecular WRD test. The second specimen may be used for the additional testing described in this algorithm. For persons being evaluated for pulmonary TB, sputum is the preferred specimen. Tissue biopsy samples are difficult or impossible to obtain repeatedly; therefore, they should be tested with as many methods as possible (e.g. molecular WRD, culture, DST or histology).
3Molecular WRD tests appropriate for this algorithm include Xpert MTB/RIF, Xpert Ultra, Truenat MTB, Truenat MTB Plus and TB‐LAMP.
4“MTB detected (not trace)” includes MTB detected as high, moderate, low or very low. These categories apply to the original Xpert MTB/RIF and Xpert Ultra tests. Results of the Truenat MTB and MTB Plus tests and the TB‐LAMP test also fall into the category of “MTB detected (not trace)”.Additional footnotes are explained in WHO Consolidated Guidelines (Module 4) 2020.This algorithm for the use of a molecular WHO‐recommended rapid diagnostic (WRD), which includes Xpert Ultra and Xpert MTB/RIF, comes from the WHO operational handbook on tuberculosis (WHO Consolidated Guidelines (Module 4) 2020). Copyright © [2020] [World Health Organization]: reproduced with permission.

Figures and Tables -
Figure 1

The clinical pathway describes how people might present and the point in the pathway at which they would be considered for testing with Xpert MTB/RIF or Xpert Ultra.

Abbreviations: DST: drug susceptibility testing; INH: isoniazid; MDR‐TB: multidrug‐resistant tuberculosis; MTB: Mycobacterium tuberculosis; mWRD: molecular WHO‐recommended rapid diagnostic; PLHIV: people living with HIV; RIF: rifampicin; TB: tuberculosis; Ultra: Xpert Ultra; WHO: World Health Organization.

1Persons to be evaluated for TB include adults and children with signs or symptoms suggestive of TB, or with a chest X‐ray with abnormalities suggestive of TB. This algorithm may also be followed for the diagnosis of extrapulmonary TB using CSF, lymph node and other tissue specimens.
2Programs may consider collecting two specimens upfront. The first specimen should be promptly tested using the molecular WRD test. The second specimen may be used for the additional testing described in this algorithm. For persons being evaluated for pulmonary TB, sputum is the preferred specimen. Tissue biopsy samples are difficult or impossible to obtain repeatedly; therefore, they should be tested with as many methods as possible (e.g. molecular WRD, culture, DST or histology).
3Molecular WRD tests appropriate for this algorithm include Xpert MTB/RIF, Xpert Ultra, Truenat MTB, Truenat MTB Plus and TB‐LAMP.
4“MTB detected (not trace)” includes MTB detected as high, moderate, low or very low. These categories apply to the original Xpert MTB/RIF and Xpert Ultra tests. Results of the Truenat MTB and MTB Plus tests and the TB‐LAMP test also fall into the category of “MTB detected (not trace)”.

Additional footnotes are explained in WHO Consolidated Guidelines (Module 4) 2020.

This algorithm for the use of a molecular WHO‐recommended rapid diagnostic (WRD), which includes Xpert Ultra and Xpert MTB/RIF, comes from the WHO operational handbook on tuberculosis (WHO Consolidated Guidelines (Module 4) 2020). Copyright © [2020] [World Health Organization]: reproduced with permission.

PRISMA flow diagram of studies in the review.*One publication contributed two distinct studies, which were classified as Mishra 2020a and Mishra 2020b.

Figures and Tables -
Figure 2

PRISMA flow diagram of studies in the review.

*One publication contributed two distinct studies, which were classified as Mishra 2020a and Mishra 2020b.

Risk of bias and applicability concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study.

Figures and Tables -
Figure 3

Risk of bias and applicability concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study.

Risk of bias and applicability concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study.

Figures and Tables -
Figure 4

Risk of bias and applicability concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study.

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in adults, unselected participants by reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 5

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for pulmonary tuberculosis in adults, unselected participants by reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).

TP = true positive; FP = false positive; FN = false negative; TN = true negative

Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.

Figures and Tables -
Figure 6

Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 7

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by HIV status and history of tuberculosis. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 8

Forest plots of Xpert Ultra versus Xpert MTB/RIF sensitivity and specificity for the detection of pulmonary tuberculosis by HIV status and history of tuberculosis. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).

TP = true positive; FP = false positive; FN = false negative; TN = true negative

Forest plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 9

Forest plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).

TP = true positive; FP = false positive; FN = false negative; TN = true negative

Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.

Figures and Tables -
Figure 10

Summary plot of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance. Each individual study is represented by a shaded circle. The size of the circle is proportional to the sample size of the study such that larger studies are represented by larger circles. The filled circle is the median pooled estimate for sensitivity and specificity, Xpert Ultra (red) and Xpert MTB/RIF (black). The dotted lines represent the 95% credible region around the summary estimate; the dashed lines represent the 95% prediction region. The range is truncated to consider only those regions of the receiver operator characteristic (ROC) space where data have been observed.

Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 11

Forest plots of Xpert Ultra and Xpert MTB/RIF sensitivity and specificity for the detection of rifampicin resistance by smear status. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI). TP = true positive; FP = false positive; FN = false negative; TN = true negative

Forest plots of repeated Xpert Ultra sensitivity and specificity for detection of pulmonary tuberculosis in adults with initial trace result, culture reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).TP = true positive; FP = false positive; FN = false negative; TN = true negative

Figures and Tables -
Figure 12

Forest plots of repeated Xpert Ultra sensitivity and specificity for detection of pulmonary tuberculosis in adults with initial trace result, culture reference standard. The squares represent the sensitivity and specificity of one study, the black line its confidence interval (CI).

TP = true positive; FP = false positive; FN = false negative; TN = true negative

Bayesian bivariate hierarchical model, likelihood.

Figures and Tables -
Figure 13

Bayesian bivariate hierarchical model, likelihood.

Bayesian bivariate hierarchical model, prior distributions.

Figures and Tables -
Figure 14

Bayesian bivariate hierarchical model, prior distributions.

Table. Risk of bias concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study, QUADAS‐C judgements.P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing

Figures and Tables -
Figure 15

Table. Risk of bias concerns summary for detection of pulmonary tuberculosis: review authors' judgements about each domain for each included study, QUADAS‐C judgements.

P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing

Table. Risk of bias concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study, QUADAS‐C judgements.P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing

Figures and Tables -
Figure 16

Table. Risk of bias concerns summary for detection of rifampicin resistance: review authors' judgements about each domain for each included study, QUADAS‐C judgements.

P: Patient selection, I: Index test, R: Reference standard, FT: Flow and Timing

Xpert Ultra for detection of pulmonary TB

Figures and Tables -
Test 1

Xpert Ultra for detection of pulmonary TB

Xpert MTB/RIF for detection of pulmonary TB

Figures and Tables -
Test 2

Xpert MTB/RIF for detection of pulmonary TB

Xpert Ultra for detection of pulmonary TB, composite reference standard

Figures and Tables -
Test 3

Xpert Ultra for detection of pulmonary TB, composite reference standard

Xpert MTB/RIF for detection of pulmonary TB, composite reference standard

Figures and Tables -
Test 4

Xpert MTB/RIF for detection of pulmonary TB, composite reference standard

Smear‐negative, Xpert Ultra, culture

Figures and Tables -
Test 5

Smear‐negative, Xpert Ultra, culture

Smear‐negative, Xpert MTB/RIF, culture

Figures and Tables -
Test 6

Smear‐negative, Xpert MTB/RIF, culture

Smear‐positive, Xpert Ultra

Figures and Tables -
Test 7

Smear‐positive, Xpert Ultra

Smear‐positive, Xpert MTB/RIF

Figures and Tables -
Test 8

Smear‐positive, Xpert MTB/RIF

HIV‐positive, Xpert Ultra

Figures and Tables -
Test 9

HIV‐positive, Xpert Ultra

HIV‐positive, Xpert MTB/RIF

Figures and Tables -
Test 10

HIV‐positive, Xpert MTB/RIF

HIV‐negative, Xpert Ultra

Figures and Tables -
Test 11

HIV‐negative, Xpert Ultra

HIV‐negative, Xpert MTB/RIF

Figures and Tables -
Test 12

HIV‐negative, Xpert MTB/RIF

Xpert Ultra, history of TB

Figures and Tables -
Test 13

Xpert Ultra, history of TB

Xpert Ultra, no history of TB

Figures and Tables -
Test 14

Xpert Ultra, no history of TB

Xpert MTB/RIF, history of TB

Figures and Tables -
Test 15

Xpert MTB/RIF, history of TB

Xpert MTB/RIF, no history of TB

Figures and Tables -
Test 16

Xpert MTB/RIF, no history of TB

Xpert Ultra for detection of rifampicin resistance

Figures and Tables -
Test 17

Xpert Ultra for detection of rifampicin resistance

Xpert MTB/RIF for detection of rifampicin resistance

Figures and Tables -
Test 18

Xpert MTB/RIF for detection of rifampicin resistance

Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard

Figures and Tables -
Test 19

Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard

Xpert Ultra for detection of rifampicin resistance, smear‐positive

Figures and Tables -
Test 20

Xpert Ultra for detection of rifampicin resistance, smear‐positive

Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive

Figures and Tables -
Test 21

Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive

Xpert Ultra for detection of rifampicin resistance, smear‐negative

Figures and Tables -
Test 22

Xpert Ultra for detection of rifampicin resistance, smear‐negative

Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative

Figures and Tables -
Test 23

Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative

Summary of findings 1. Xpert Ultra versus Xpert MTB/RIF for the detection of pulmonary tuberculosis*

Review question: what is the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for the detection of pulmonary tuberculosis?

Patients/population: adults with presumptive pulmonary tuberculosis. Participants were unselected, meaning they were not enrolled in a study based on microscopy smear results or history of tuberculosis

Role: an initial test

Index tests: Xpert Ultra and Xpert MTB/RIF

Threshold for index tests: an automated result is provided

Reference standards: solid or liquid culture

Studies: cross‐sectional and cohort studies

Setting: primary care facilities and local hospitals

Xpert Ultra sensitivity 90.9% (86.2 to 94.7) and specificity 95.6% (93.0 to 97.4)

Xpert MTB/RIF sensitivity 84.7% (78.6 to 89.9) and specificity 98.4% (97.0 to 99.3)

Test result

Number of results per 1000 patients tested (95% CrI)**

Number of participants***
(studies)

Certainty of the evidence (GRADE)

Prevalence 2.5%

Prevalence 10%

Prevalence 30%

Xpert Ultra

Xpert MTB/RIF

Xpert Ultra

Xpert MTB/RIF

Xpert Ultra

Xpert MTB/RIF

True positives (TP)

23

(22 to 24)

21

(20 to 22)

91

(86 to 95)

85

(79 to 90)

273

(259 to 284)

254

(236 to 270)

983 (7)

⊕⊕⊕⊕

High

2 more TP in Xpert Ultra

6 more TP in Xpert Ultra

19 more TP in Xpert Ultra

False negatives (FN)

2

(1 to 3)

4

(3 to 5)

9

(5 to 14)

15

(10 to 21)

27 (16 to 41)

46

(30 to 64)

2 fewer FN in Xpert Ultra

6 fewer FN in Xpert Ultra

19 fewer FN in Xpert Ultra

True negatives (TN)

932 (907 to 950)

959 (946 to 968)

860 (837 to 877)

886 (873 to 894)

669 (651 to 682)

689 (679 to 695)

1852 (7)

⊕⊕⊕⊕

High

27 fewer TN in Xpert Ultra

26 fewer TN in Xpert Ultra

20 fewer TN in Xpert Ultra

False positives (FP)

43 (25 to 68)

16 (7 to 29)

40 (23 to 63)

14 (6 to 27)

31 (18 to 49)

11 (5 to 21)

27 more FP in Xpert Ultra

26 more FP in Xpert Ultra

20 more FP in Xpert Ultra

Abbreviations: CrI: credible interval

GRADE certainty of the evidence

High: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

*The results presented in this table should not be interpreted in isolation from the results of individual included studies contributing to each summary test accuracy measure.

**95% credible limits were estimated based on those around the point estimates for pooled sensitivity and specificity. Prevalence estimates were suggested by the World Health Organization Global Tuberculosis Programme. The median tuberculosis prevalence in the included studies was 30.1% (range 12.8% to 72.2%).

***In the Xpert Ultra analysis there were 1851 participants. Piersimoni 2019 reported three non‐determinate results for Xpert Ultra and two for Xpert MTB/RIF, accounting for the small difference in the total number of participants.

Figures and Tables -
Summary of findings 1. Xpert Ultra versus Xpert MTB/RIF for the detection of pulmonary tuberculosis*
Summary of findings 2. Xpert Ultra versus Xpert MTB/RIF for the detection of rifampicin resistance*

Review question: what is the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for the detection of rifampicin resistance?

Patients/population: adults with presumptive pulmonary tuberculosis

Role: an initial test

Index tests: Xpert Ultra and Xpert MTB/RIF

Threshold for index tests: an automated result is provided

Reference standards: drug susceptibility testing, line probe assay

Studies: cross‐sectional and cohort studies

Setting: primary care facilities and local hospitals

Xpert Ultra sensitivity 94.9% (88.9 to 97.9) and specificity 99.1% (97.7 to 99.8)

Xpert MTB/RIF sensitivity 95.3% (90.0 to 98.1) and specificity 98.8% (97.2 to 99.6)

Test result

Number of results per 1000 patients tested (95% CrI)**

Number of participants***
(studies)

Certainty of the evidence (GRADE)

Prevalence 2%

Prevalence 10%

Prevalence 15%

Xpert Ultra

Xpert MTB/RIF

Xpert Ultra

Xpert MTB/RIF

Xpert Ultra

Xpert MTB/RIF

True positives (TP)

19

(18 to 20)

19

(18 to 20)

95 (89 to 98)

95 (90 to 98)

142

(133 to 147)

143

(135 to 147)

238 (5)

⊕⊕⊕⊕

High

0 fewer TP in Xpert Ultra

0 fewer TP in Xpert Ultra

1 fewer TP in Xpert Ultra

False negatives (FN)

1 (0 to 2)

1 (0 to 2)

5 (2 to 11)

5 (2 to 10)

8 (3 to 18)

7 (3 to 15)

0 fewer FN in Xpert Ultra

0 fewer FN in Xpert Ultra

1 more FN in Xpert Ultra

True negatives (TN)

971 (957 to 977)

968 (953 to 976)

892 (879 to 897)

889 (875 to 896)

842 (830 to 847)

840 (826 to 847)

692 (5)

⊕⊕⊕⊕

High

3 more TN in Xpert Ultra

3 more TN in Xpert Ultra

2 more TN in Xpert Ultra

False positive (FP)

9 (3 to 23)

12 (4 to 27)

8 (3 to 21)

11 (4 to 25)

8 (3 to 20)

10 (3 to 24)

3 fewer FP in Xpert Ultra

3 fewer FP in Xpert Ultra

2 fewer FP in Xpert Ultra

Abbreviations: CrI: credible interval

GRADE certainty of the evidence

High: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

*The results presented in this table should not be interpreted in isolation from results of the individual included studies contributing to each summary test accuracy measure.

**Prevalence estimates were suggested by the World Health Organization Global Tuberculosis Programme. The median prevalence of rifampicin resistance in the included studies was 23.6% (range 1.9% to 31.8%). Credible limits were estimated based on those around the point estimates for pooled sensitivity and specificity.

***Xpert Ultra included 921 participants, and Xpert MTB/RIF included 930 participants, mainly owing to indeterminate results with Xpert Ultra.

Figures and Tables -
Summary of findings 2. Xpert Ultra versus Xpert MTB/RIF for the detection of rifampicin resistance*
Table 1. Summary of key study characteristics

Study, year ID

Country

Study design

Number of participants

Age

(mean or median; years)

Female sex

HIV‐positive

History of tuberculosis

Pulmonary tuberculosis reference standard

Rifampicin resistance reference standard

Berhanu 2018

South Africa

Prospective cohort

237

36

33%

62%

18%

LJ and MGIT; composite

LJ, MGIT, and MTBDRplus

Chakravorty 2017

FIND biobank frozen specimens (Peru, Vietnam, South Africa) and clinical specimens (Georgia, India)

Cross‐sectional

277

Not reported

Not reported

Not reported

Not reported

LJ and MGIT

LJ and MGIT

Dorman 2018

Belarus, Brazil, China, Georgia, India, Kenya, South Africa, Uganda

Prospective cohort

1439 for detection of MTB, 551 for detection of rifampicin resistance

28

40%

44%

21%

LJ and MGIT

LJ and MGIT

Mishra 2020a

South Africa

Prospective cohort

239

37

49%

20%

39%

MGIT

MTBDRplus

Mishra 2020b

South Africa

Cross‐sectional

346

38

40%

44%

100%

MGIT

MTBDRplus

Opota 2019

Switzerland

Cross‐sectional

196

Not reported

Not reported

Not reported

Not reported

MGIT; composite

MGIT

Pereira 2020

Brazil

Cross‐sectional

180

50

44%

2%

0%

Ogawa‐Kudoh

N/A

Piersimoni 2019

Italy

Cross‐sectional

266

42

37%

Not reported

Excluded

MGIT

MGIT

Wang 2019

China

Prospective cohort

498

47

34%

0%

50%

LJ and MGIT

LJ

Abbreviations: FIND: Foundation for Innovative New Diagnostics; LJ: Löwenstein–Jensen; MGIT: Mycobacteria Growth Indicator Tube; MTB; Mycobacterium tuberculosis; N/A: not applicable.

Figures and Tables -
Table 1. Summary of key study characteristics
Table 2. Xpert Ultra and Xpert MTB/RIF for the detection of pulmonary tuberculosis and rifampicin resistance

Test (analysis)

Reference standard

No. studies (participants)

No. (%) with pulmonary TB or rifampicin resistance

Median pooled sensitivity
(95% CrI)

Median pooled specificity
(95% CrI)

Positive predictive value (95% CrI) *

Negative predictive value
(95% CrI)

Xpert Ultra, unselected participants* (pulmonary tuberculosis detection)

Culture

7 (2834)**

983 (34.7%)

90.9% (86.2 to 94.7)

95.6% (93.0 to 97.4)

69.6% (58.7 to 79.8)

99.0% (98.4 to 99.4)

Xpert MTB/RIF (pulmonary tuberculosis detection)

Culture

7 (2835)

983 (34.7%)

84.7% (78.6 to 89.9)

98.4% (97.0 to 99.3)

85.4% (75.8 to 93.1)

98.3% (97.6 to 98.9)

Xpert Ultra (rifampicin resistance detection)

DST, line probe assays

5 (921)

240 (26.1%)

94.9% (88.9 to 97.9)

99.1% (97.7 to 99.8)

91.7% (82.1 to 97.4)

99.4% (98.7 to 99.8)

Xpert MTB/RIF (rifampicin resistance detection)

DST, line probe assays

5 (930)

238 (25.6%)

95.3% (90.0 to 98.1)

98.8% (97.2 to 99.6)

99.5% (98.9 to 99.8)

99.4% (98.7 to 99.8)

Abbreviations: CrI: credible interval; DST: drug susceptibility testing with solid or liquid culture methods

* Positive and negative predictive values were determined at a pretest probability of 10%

**This analysis included studies that did not preselect participants based on microcopy results or those who had received previous antituberculosis treatment.
***Piersimoni 2019 reported three non‐determinate results for Xpert Ultra and two for Xpert MTB/RIF, accounting for the small difference in the total number of participants in this analysis.

Figures and Tables -
Table 2. Xpert Ultra and Xpert MTB/RIF for the detection of pulmonary tuberculosis and rifampicin resistance
Table 3. Comparative accuracy of Xpert Ultra and Xpert MTB/RIF*

Detection of pulmonary tuberculosis

Test (studies, participants)

Xpert Ultra (7, 2834)

Xpert MTB/RIF (7, 2835)

Difference (Xpert Ultra minus Xpert MTB/RIF)*

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

90.9% (86.2 to 94.7)

84.7% (78.6 to 89.9)

6.3% (0.1 to 12.8)

0.98

Specificity (95% CrI)

95.6% (93.0 to 97.4)

98.4% (97.0 to 99.3)

−2.7% (−5.7 to −0.5)

0.01

Smear‐positive (tuberculosis detection)

Test (studies, participants)

Xpert Ultra (6, 593)

Xpert MTB/RIF (6, 598)

Difference (Xpert Ultra minus Xpert MTB/RIF)**

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

99.3% (98.1 to 99.8)

98.9% (97.5 to 99.6)

0.3% (−1.0 to 1.8)

0.72

Specificity (95% CrI)

Not estimated

Not estimated

N/A

N/A

Smear‐negative (tuberculosis detection)

Test (studies, participants)

Xpert Ultra (6, 2049)

Xpert MTB/RIF (6, 2051)

Difference (Xpert Ultra minus Xpert MTB/RIF)**

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

77.5% (67.6 to 85.6)

60.6% (48.4 to 71.7)

16.7% (2.1 to 31.8)

1.00

Specificity (95% CrI)

95.8% (92.9 to 97.7)

98.8% (97.7 to 99.5)

−3.0% (‐5.9 to −0.9)

0.00

History of tuberculosis

Test (studies, participants)

Xpert Ultra (4, 602)

Xpert MTB/RIF (4, 610)

Difference (Xpert Ultra minus Xpert MTB/RIF)*

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

84.2% (72.5 to 91.7)

81.8% (68.7 to 90.0)

2.4% (−11.9 to 17.2)

0.64

Specificity (95% CrI)

88.2% (70.5 to 96.6)

97.4% (91.7 to 99.5)

−8.9% (−27.0 to 0.6)

0.03

Detection of rifampicin resistance

Test (studies, participants)

Xpert Ultra (5, 921)

Xpert MTB/RIF (5, 930)

Difference (Xpert Ultra minus Xpert MTB/RIF)**

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

94.9% (88.9 to 97.9)

95.3% (90.0 to 98.1)

−0.3% (−6.9 to 5.7)

0.45

Specificity (95% CrI)

99.1% (97.7 to 99.8)

98.8% (97.2 to 99.6)

0.3% (−1.2 to 2.0)

0.67

Smear‐positive (rifampicin resistance detection)

Test (studies, participants)

Xpert Ultra (4, 686)

Xpert MTB/RIF (4, 699)

Difference (Xpert Ultra minus Xpert MTB/RIF)**

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

93.9% (84.4 to 97.7)

95.5% (88.4 to 98.6)

−1.5% (−10.9 to 6.0)

0.32

Specificity (95% CrI)

99.3% (97.8 to 99.9)

99.1% (97.3 to 99.9)

0.1% (−1.5 to 2.0)

0.59

Smear‐negative (rifampicin resistance detection)

Test (studies, participants)

Xpert Ultra (4, 412)

Xpert MTB/RIF (4, 416)

Difference (Xpert Ultra minus Xpert MTB/RIF)**

Probability (Xpert Ultra minus Xpert MTB/RIF)

Sensitivity (95% CrI)

92.0% (75.0 to 95.8)

95.4% (82.3 to 99.3)

−3.1% (−20.7 to 11.7)

0.30

Specificity (95% CrI)

99.4% (96.2 to 100)

99.2% (94.8 to 100)

0.1% (−3.0 to 4.5)

0.58

Abbreviations: CrI: credible interval

* We determined absolute differences for sensitivity and specificity when there were at least four studies in a subgroup.
** Slight differences in numerical values are likely due to rounding errors.

Figures and Tables -
Table 3. Comparative accuracy of Xpert Ultra and Xpert MTB/RIF*
Table 4. Xpert Ultra and Xpert MTB/RIF accuracy, analyses in HIV‐positive and HIV‐negative people

Analysis

Test

No. of studies (participants)

Median pooled sensitivity
(95% CrI)

Median pooled specificity
(95% CrI)

Positive predictive value
(95% CI) *

Negative predictive value
(95% CI)

HIV‐negative

Xpert Ultra

3 (755)

90.3% (80.3 to 95.6)

94.3% (79.8 to 98.7)

63.5% (45.6 to 79.7)

98.9% (97.7 to 99.5)

HIV‐negative

Xpert MTB/RIF

3 (755)

89.0% (78.3 to 94.8)

98.1% (95.3 to 99.4)

83.8% (67.6 to 94.0)

98.8% (97.6 to 99.4)

HIV‐positive

Xpert Ultra

3 (627)

87.6% (75.4 to 94.1)

92.8% (82.3 to 97.0)

57.4% (34.5 to 76.8)

98.5% (97.0 to 99.3)

HIV‐positive

Xpert MTB/RIF

3 (635)

74.9% (58.7 to 86.2)

99.7% (98.6 to 100.0)

96.3% (85.4 to 99.6)

97.3% (95.6 to 98.5)

Abbreviations: CI: confidence interval; CrI: credible interval

* Positive and negative predictive values were determined at a pretest probability of 10%

Figures and Tables -
Table 4. Xpert Ultra and Xpert MTB/RIF accuracy, analyses in HIV‐positive and HIV‐negative people
Table 5. Summary of Xpert Ultra trace‐positive results

Study

Country

Culture‐positive MTB/total

Trace results (% of Ultra positive)

Number (%) of trace results with history of tuberculosis

Culture‐positive trace/total trace

Additional testing on trace results (not including retesting)

Trace results repeated?

Berhanu 2018

South Africa

56/237

6 (10.3%)

1/5 (20.0%); this 1 patient was culture positive

2/6

Sputum re‐collected at day 60 in 1 participant was MGIT negative.

No

Chakravorty 2017

FIND biobank samples (Peru, Vietnam, South Africa) and clinical samples (Georgia, India)

200/277

Not reported

No

Dorman 2018

Belarus, Brazil, China, Georgia, India, Kenya, South Africa, Uganda

462/1439

32 (7.1%)

Of 19 culture‐negative trace results, 11 (57.9%) had history of TB.

13/32

Among culture‐negative, a follow‐up culture at 2 months was positive in 2/10.

Yes: 13 of the retested samples were culture+; of these 9 were Ultra + on repeat. 19 of the samples were culture‐, of which 10 were Ultra false +

Mishra 2020a

South Africa

72/239

13 (18.6%)

6/13 (46.2%)

4/13

Yes: new sample collected median 444 days, after the initial testing. 4 samples retested (1 culture+, 3 culture‐); all culture‐ were not detected, and culture+ was Ultra +

Mishra 2020b

South Africa

44/168

21 (27.6%)

21/21 (100%)

2/21

No

Opota 2019

Switzerland

47/196

5 (10.0%)

Not reported

4/5

The 1 culture‐negative patient was culture‐positive on a lymph node specimen.

No

Pereira 2020

Brazil

157/180

1 (3.0%)

Not reported

Not reported

No

Piersimoni 2019

Italy

123/266

8 (6.7%)

Excluded from study

5/8

Yes: 4 respiratory samples retested (1 culture+, 3 culture‐); all culture‐ were not detected, and culture+ was Ultra +

Wang 2019

China

117/498

65 (30.4%)

Not reported

Not reported

No

Abbreviations: FIND: Foundation for Innovative New Diagnostics; MGIT: Mycobacteria Growth Indicator Tube; MTB: Mycobacterium tuberculosis; TB: tuberculosis

‐ Could not determine

Figures and Tables -
Table 5. Summary of Xpert Ultra trace‐positive results
Table 6. Sensitivity analyses, Xpert Ultra

Type of analysis (no. of studies, participants)

Median pooled sensitivity (95% Crl)

Median pooled specificity (95% Crl)

Positive predictive value
(95% CrI)

Negative predictive value
(95% CrI)

Xpert Ultra sensitivity and specificity for pulmonary tuberculosis detection in studies with unselected patients (7, 2834)

90.9% (86.2 to 94.7)

95.6% (93.0 to 97.4)

69.6% (58.7 to 79.8)

99.0% (98.4 to 99.4)

Studies that only included untreated participants (exclude studies with some percentage of participants who were receiving tuberculosis treatment) (5, 2361)

90.9% (84.7 to 95.3)

94.9% (91.3 to 97.2)

66.4% (53.2 to 78.4)

98.9% (98.2 to 99.5)

Studies that used liquid culture only as the reference standard for tuberculosis detection (4, 978)

91.1% (84.0 to 95.5)

96.1% (91.7 to 98.5)

72.1% (54.5 to 87.2)

99.0% (98.2 to 99.5)

Studies where consecutive or random participants were selected (6, 2557)

91.6% (86.6 to 95.4)

95.3% (92.4 to 97.2)

68.2% (56.9 to 78.5)

99.0% (98.5 to 99.5)

Studies where the reference standard was blinded (6, 2654)

90.2% (85.2 to 93.8)

95.9% (93.0 to 97.7)

70.8% (58.5 to 81.8)

98.9% (98.3 to 99.3)

Studies using fresh specimens (4, 2095)

89.8% (82.1 to 95.1)

94.1% (89.3 to 96.8)

62.7% (47.9 to 75.8)

98.8% (97.9 to 99.4)

Abbreviations: Crl: credible interval.

Figures and Tables -
Table 6. Sensitivity analyses, Xpert Ultra
Table 7. Selected systematic reviews on the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance

Author, year (see descriptions of systematic reviews in footnotes)

Date searched up to

No. of studies (participants)

Test

Pulmonary tuberculosis, summary estimates
(95% CI)*

No. of studies

Rifampicin resistance, summary estimates (95% CrI)*

Sensitivity

Specificity

Sensitivity

Specificity

Chang 2012

October

2011

15 (8117)

Xpert MTB/RIF

90% (89 to 91)

98% (98 to 99)

7

See footnote for this study

See footnote for this study

Walusimbi 2013

(smear‐negative)

May
2012

15 (2046)

Xpert MTB/RIF

67% (62 to 71)

98% (97 to 99)

N/A

N/A

N/A

Steingart 2014

December
2013

27 (6026)

Xpert MTB/RIF

89% (85 to 92)

99% (98 to 99)

Sensitivity: 17
Specificity: 24

95% (90 to 97)

98% (97 to 99)

Yan 2016

Not reported

12 (8122)

Xpert MTB/RIF

89% (87 to 90)

98% (98 to 99)

N/A

N/A

N/A

Li 2017

June
2015

24 (2486)

Xpert MTB/RIF

87% (83 to 90)

97% (96 to 98)

N/A

N/A

N/A

Alvis‐Zakzuk 2017

December
2015

N/A

Xpert MTB/RIF

N/A

N/A

8

See footnote for this study

See footnote for this study

Horne 2019

January
2018

85 (41,965)

Xpert MTB/RIF

85% (82 to 87)

98% (97 to 98)

48 (8020)

96% (94 to 97)

98% (98 to 99)

Zhang 2019

May 2019

10 (not reported)

Xpert

Ultra

89% (82 to 94)

97% (95 to 98)

4 (856)

95% (92 to 97)

99% (98 to 100)

Jiang 2020

April 2020

19 (5855)

Xpert Ultra and Xpert MTB/RIF

Xpert MTB/RIF: 69% (57 to 78)

Xpert Ultra:

84% (76 to 90)

Xpert MTB/RIF: 99% (98 to 99)

Xpert Ultra:

97% (96 to 98)

N/A

N/A

N/A

Abbreviations: CI: confidence interval; Crl: credible interval; N/A: not applicable.

*Summary sensitivity and specificity estimates are provided for Xpert MTB/RIF, except for Zhang 2019 and Jiang 2020, which evaluated Xpert Ultra.

Chang 2012 included adults and children; Xpert MTB/RIF for detection of rifampicin resistance, sensitivity range 17% to 100%, specificity range 72% to 100%.
Walusimbi 2013 only included smear‐negative participants.
Steingart 2014 is a previous Cochrane Review.
Yan 2016 only included studies that provided data by smear and HIV status.
Li 2017 106 studies (52,410 specimens) for both pulmonary and extrapulmonary tuberculosis.
Alvis‐Zakzuk 2017 summarized accuracy of Xpert MTB/RIF for the detection of rifampicin resistance, sensitivity range 33% to 100%, specificity range 91% to 100%.
Horne 2019 is a previous Cochrane Review update.
Zhang 2019 included adults and children.
Jiang 2020 included adults and children, and assessed Xpert Ultra and Xpert MTB/RIF accuracy for the detection of both pulmonary and extrapulmonary tuberculosis.

Systematic reviews not included in this table:

Kaur 2016 did not provide summary sensitivity and specificity estimates.
Lange 2017 provided sensitivity and specificity with respect to Xpert cycle threshold (CT) values.
Maynard‐Smith 2014 provided accuracy estimates for pulmonary tuberculosis on gastric aspirates and stool.
Wang 2015 only included children.

Figures and Tables -
Table 7. Selected systematic reviews on the diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance
Table 8. Prespecified changes for 2021 review update*

Protocol section

Refreshed protocol

Background and research question

This review update will describe the burden of pulmonary tuberculosis worldwide based on the latest World Health Organization (WHO) Global Tuberculosis Report. The Background will describe the updated WHO guidelines on molecular methods for diagnosing tuberculosis, including Xpert MTB/RIF and Xpert Ultra. The WHO Meeting to update the guidelines will take place 3 to 6 December 2019. This Cochrane Review update will have informed these guidelines.

Inclusion criteria

This is a diagnostic test accuracy review. Participants, index tests, and target condition will be the same as in Horne 2019. We will add a composite reference standard for Xpert Ultra defined as culture or clinical criteria as defined by the primary study authors, or both.

The primary objectives are to assess the diagnostic accuracy of Xpert Ultra for the diagnosis of pulmonary tuberculosis and to assess the diagnostic accuracy of Xpert Ultra for the diagnosis rifampicin resistance in adults.

Secondary objectives are as follows:

  • to investigate potential sources of heterogeneity in test accuracy, including history of tuberculosis and smear and HIV status;

  • to compare the accuracy of Xpert Ultra and Xpert MTB/RIF in studies that evaluated both tests.

Concerning patient outcomes, the Discussion will summarize and refer to key findings in the test‐treatment Cochrane Review by Haraka 2018.

Methods

We will use QUADAS‐2 to appraise methodological quality of the included studies, consistent with Horne 2019.

If there are sufficient data, we will perform meta‐analyses using a bivariate random‐effects model. The analyses will include:

  • Xpert Ultra for pulmonary tuberculosis, culture reference standard;

  • Xpert Ultra for pulmonary tuberculosis, composite reference standard;

  • accuracy of Xpert Ultra versus Xpert MTB/RIF in studies that evaluated both tests;

  • Xpert Ultra for pulmonary tuberculosis, smear‐positive;

  • Xpert Ultra for pulmonary tuberculosis, smear‐negative, culture positive;

  • Xpert Ultra for pulmonary tuberculosis, HIV‐positive;

  • Xpert Ultra for pulmonary tuberculosis in participants with a history of tuberculosis;

  • Xpert Ultra for detecting rifampicin resistance.

We will create 'Summary of findings' tables for the two primary objectives of the review.

*This table was approved by the Cochrane Infectious Diseases Group editorial team on 23 October 2019.

Figures and Tables -
Table 8. Prespecified changes for 2021 review update*
Table Tests. Data tables by test

Test

No. of studies

No. of participants

1 Xpert Ultra for detection of pulmonary TB Show forest plot

9

3500

2 Xpert MTB/RIF for detection of pulmonary TB Show forest plot

7

2835

3 Xpert Ultra for detection of pulmonary TB, composite reference standard Show forest plot

2

433

4 Xpert MTB/RIF for detection of pulmonary TB, composite reference standard Show forest plot

2

433

5 Smear‐negative, Xpert Ultra, culture Show forest plot

7

2547

6 Smear‐negative, Xpert MTB/RIF, culture Show forest plot

7

2549

7 Smear‐positive, Xpert Ultra Show forest plot

6

593

8 Smear‐positive, Xpert MTB/RIF Show forest plot

6

598

9 HIV‐positive, Xpert Ultra Show forest plot

3

627

10 HIV‐positive, Xpert MTB/RIF Show forest plot

3

635

11 HIV‐negative, Xpert Ultra Show forest plot

3

755

12 HIV‐negative, Xpert MTB/RIF Show forest plot

3

755

13 Xpert Ultra, history of TB Show forest plot

4

602

14 Xpert Ultra, no history of TB Show forest plot

3

1476

15 Xpert MTB/RIF, history of TB Show forest plot

4

610

16 Xpert MTB/RIF, no history of TB Show forest plot

3

1476

17 Xpert Ultra for detection of rifampicin resistance Show forest plot

5

921

18 Xpert MTB/RIF for detection of rifampicin resistance Show forest plot

5

930

19 Xpert Ultra repeated test in adults with initial trace result, microbiological reference standard Show forest plot

3

40

20 Xpert Ultra for detection of rifampicin resistance, smear‐positive Show forest plot

4

686

21 Xpert MTB/RIF for detection of rifampicin resistance, smear‐positive Show forest plot

4

699

22 Xpert Ultra for detection of rifampicin resistance, smear‐negative Show forest plot

4

412

23 Xpert MTB/RIF for detection of rifampicin resistance, smear‐negative Show forest plot

4

416

Figures and Tables -
Table Tests. Data tables by test