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. 2019 Aug;94(4):349-354.
doi: 10.1016/j.diagmicrobio.2019.02.006. Epub 2019 Feb 10.

Migrating a lab-developed MERS-CoV real-time PCR to 3 "Sample to Result" systems: experiences on optimization and validation

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Migrating a lab-developed MERS-CoV real-time PCR to 3 "Sample to Result" systems: experiences on optimization and validation

Glynis Frans et al. Diagn Microbiol Infect Dis. 2019 Aug.

Abstract

The goal of the study was to adapt our Middle East respiratory syndrome coronavirus (MERS-CoV) lab-developed test (LDT) to 3 "Sample to Result" (S2R) systems: BD MAX (BD), ELITe InGenius (ELITechGroup), and ARIES (Luminex). The BD MAX and InGenius system allowed use of lab-developed primers and TaqMan probes, while ARIES required conversion to MultiCode primers for melting curve analysis. Each device required ≤1 day of training and assay optimization. No discordant results were noted after analysis of 32 External Quality Control (EQC) samples. On a 10-fold dilution series of a MERS-CoV-positive EQC sample, InGenius obtained the highest detection rate. Laboratory technicians rated the ARIES as the user-friendliest. It also required the least hands-on time. BD MAX had the lowest turnaround time and highest throughput. While each device had distinguishing system properties with associated (dis)advantages, the 3 S2R systems were comparable in terms of assay development and validation.

Keywords: ARIES; BD MAX; ELITe InGenius; Middle East respiratory syndrome coronavirus; Sample to result systems.

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Figures

Fig. 1
Fig. 1
Graphical representation of the sample preparation, device loading, TNA extraction, PCR, and clean-up for the BD MAX, ELITe InGenius, and Luminex ARIES. Copyright statement:Fig. 1contains several images derived from device product manuals. Permission was obtained from BD, ELITech, and Luminex to include these images in our manuscript.

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