What question did this study set out to answer?

To evaluate the diagnostic concordance between the automated Roche cobas 6800 SARS-CoV-2 assay and a laboratory-developed real-time RT-PCR test for detecting viral infection in clinical specimens.

May 8, 2020Journal of Medical VirologyOpen Access

Comparison of SARS‐CoV‐2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS‐CoV‐2 test and a laboratory‐developed real‐time RT‐PCR test

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Authors

EPElisabet PujadasIcahn School of Medicine at Mount Sinai NINnaemeka IbehMount Sinai Health System MHMatthew M. HernandezIcahn School of Medicine at Mount Sinai

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Implication

Diagnostic comparative study demonstrates high concordance between automated and laboratory-developed RT-PCR tests in patient swab samples, highlighting reliable diagnostic platform alternatives.

Key Points

To evaluate the diagnostic concordance between the automated Roche cobas 6800 SARS-CoV-2 assay and a laboratory-developed real-time RT-PCR test for detecting viral infection in clinical specimens.
Evaluated 1006 nasopharyngeal swab samples in universal transport medium collected from persons under investigation at Mount Sinai Health System.
Tested samples using the automated cobas SARS-CoV-2 platform followed by a laboratory-developed real-time RT-PCR test based on a modified CDC protocol.
Analyzed cycle threshold values and classified outcomes as positive, negative, inconclusive, or invalid, assessing agreement via Cohen's κ coefficient.
The cobas test identified 706 positive and 300 negative samples, while the laboratory test identified 640 positive, 323 negative, 34 inconclusive, and 9 invalid samples.
Excluding inconclusive and invalid results, the overall percent agreement was 95.8% with an overall discordance rate of 4.2%.
Inter-assay agreement was near perfect, yielding a Cohen's κ coefficient of 0.904 (95% CI, 0.875–0.933).

Cite This Study

Pujadas et al. (2020) studied this question.

synapsesocial.com/papers/6a71f43675498292b70b3f2c https://doi.org/10.1002/jmv.25988

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Implication

Diagnostic comparative study demonstrates high concordance between automated and laboratory-developed RT-PCR tests in patient swab samples, highlighting reliable diagnostic platform alternatives.

Comparison of SARS‐CoV‐2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS‐CoV‐2 test and a laboratory‐developed real‐time RT‐PCR test

Discussion

Member takes

Implication

Key Points

Cite This Study

Comparison of SARS‐CoV‐2 detection from nasopharyngeal swab samples by the Roche cobas 6800 SARS‐CoV‐2 test and a laboratory‐developed real‐time RT‐PCR test

Discussion

Member takes

Implication

Key Points

Cite This Study

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