Clinical performance and sample freeze-thaw stability of the cobas®6800 SARS-CoV-2 assay for the detection of SARS-CoV-2 in oro-/nasopharyngeal swabs and lower respiratory specimens

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Joep J J M StohrSuzan D Pas

Abstract

Studies describing the performance characteristics of the cobas®6800 system for SARS-CoV-2 detection in deep respiratory specimens and freeze-thaw stability are limited. The current study compares the clinical performance of the automated SARS-CoV-2 assay on the cobas®6800 system to a lab-developed assay (LDA) and the cobas impact of freeze-thawing combined with lysis buffer. Both retrospective and prospectively selected deep respiratory samples and oro- and nasopharyngeal samples in either E-swab® or GLY- were tested using the SARS-CoV-2 assay on the cobas®6800 System and compared to a lab developed assay. Additonally, SARS-CoV-2 RNA stability was assessed after one freeze-thaw cycle with or without lysis buffer. In total, 221 (58.3 %) oro- and nasopharyngeal swabs, 131 (34.6 %) deep respiratory specimens, and n = 25 (6.6 %) swabs of unknown origin were included to study clinical performance. Only 4 samples gave discrepant results, all being positive in the LDA and not the cobas®6800 system. For stability testing, 66 samples without and 110 with lysis buffer were included. No clinically significant difference was found in test results after one freeze-thaw cycle and addition of lysis buffer. Based on our findings, the cobas®68...Continue Reading

Citations

Dec 17, 2020·Infection Control and Hospital Epidemiology : the Official Journal of the Society of Hospital Epidemiologists of America·Carla BeneaBenjamin M Smith
Aug 7, 2021·Journal of Medical Microbiology·Farah M ShurrabGheyath K Nasrallah

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Methods Mentioned

BETA
PCR
nucleic acid amplification
bronchoalveolar
lavage
nucleic acid extraction
RNA
RNA assay

Software Mentioned

Researchpy
Pandas
Matplotlib
NumPy
SciPy

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