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A Comparison of Five SARS-CoV-2 Molecular Assays With Clinical Correlations.
- Source :
-
American Journal of Clinical Pathology . Jan2021, Vol. 155 Issue 1, p69-78. 10p. - Publication Year :
- 2021
-
Abstract
- <bold>Objectives: </bold>Comparative assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular assays that have been operationalized through the US Food and Drug Administration's Emergency Use Authorization process are warranted to assess real-world performance. Characteristics such as sensitivity, specificity, and false-negative rate are important to inform clinical use.<bold>Methods: </bold>We compared five SARS-CoV-2 assays using nasopharyngeal and nasal swab specimens submitted in transport media; we enriched this cohort for positive specimens, since we were particularly interested in the sensitivity and false-negative rate. Performance of each test was compared with a composite standard.<bold>Results: </bold>The sensitivities and false-negative rates of the 239 specimens that met inclusion criteria were, respectively, as follows: Centers for Disease Control and Prevention 2019 nCoV Real-Time RT-PCR Diagnostic Panel, 100% and 0%; TIB MOLBIOL/Roche z 480 Assay, 96.5% and 3.5%; Xpert Xpress SARS-CoV-2 (Cepheid), 97.6% and 2.4%; Simplexa COVID-19 Direct Kit (DiaSorin), 88.1% and 11.9%; and ID Now COVID-19 (Abbott), 83.3% and 16.7%.<bold>Conclusions: </bold>The assays that included a nucleic acid extraction followed by reverse transcription polymerase chain reaction were more sensitive than assays that lacked a full extraction. Most false negatives were seen in patients with low viral loads, as extrapolated from crossing threshold values. [ABSTRACT FROM AUTHOR]
- Subjects :
- *SARS-CoV-2
*COVID-19
*NUCLEIC acid amplification techniques
Subjects
Details
- Language :
- English
- ISSN :
- 00029173
- Volume :
- 155
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- American Journal of Clinical Pathology
- Publication Type :
- Academic Journal
- Accession number :
- 147931302
- Full Text :
- https://doi.org/10.1093/ajcp/aqaa181