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Arch Pathol Lab Med ; 144(11): 1303-1310, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-937676

ABSTRACT

CONTEXT.­: We implemented multiple nucleic acid amplification test platforms because of the limited availability of test kits for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the early stages of the pandemic. Interpretation of results generated by different platforms and prioritization for testing algorithms required cross-comparison. OBJECTIVE.­: To compare the analytical sensitivity of 3 commercial SARS-CoV-2 molecular assays, selected samples were studied in parallel with Cobas SARS-CoV-2 test, NxTAG CoV Extended Panel, and ID NOW COVID-19 assays. DESIGN.­: A total of 8043 SARS-CoV-2 tests performed from March 22 to April 19, 2020, were included in this study. For all 1794 positive specimens detected by the cobas SARS-CoV-2 assay, the cycle threshold (Ct) values were manually tracked and plotted to demonstrate the distribution of sample viral levels. Additionally, 50 and 63 low-positive specimens (Ct values >32) as well as 50 and 61 consecutive positive specimens by the cobas assay were tested with NxTAG and ID NOW, respectively, to estimate their relative sensitivities. RESULTS.­: The Ct values of cobas SARS-CoV-2-positive samples were evenly distributed throughout ranges of 13.32 to 39.50 (mean, 25.06) and 13.60 to 42.49 (mean, 26.45) for ORF1 and E gene targets, respectively. NxTAG reliably detected only specimens with E gene Ct values lower than 33, and is estimated to detect 89.4% of positive specimens detected by cobas assay. ID NOW had performance variation independent of Ct value and is estimated to detect 83.5% of cobas positives. CONCLUSIONS.­: Clinical specimens exhibit a wide range of viral burden, with a significant portion at low levels. Analytical sensitivity of testing platforms is critical for reliable detection of SARS-CoV-2 and uniform care to patients.


Subject(s)
Betacoronavirus/genetics , Coronavirus Infections/diagnosis , Molecular Diagnostic Techniques/methods , Nucleic Acid Amplification Techniques/methods , Pneumonia, Viral/diagnosis , SARS Virus/genetics , Severe Acute Respiratory Syndrome/diagnosis , Adult , Betacoronavirus/isolation & purification , Betacoronavirus/physiology , COVID-19 , Clinical Laboratory Techniques/methods , Coronavirus Infections/virology , Diagnosis, Differential , Early Diagnosis , Female , Humans , Male , Middle Aged , Nasopharynx/pathology , Nasopharynx/virology , Pandemics , Pneumonia, Viral/virology , SARS Virus/isolation & purification , SARS Virus/physiology , SARS-CoV-2 , Sensitivity and Specificity , Severe Acute Respiratory Syndrome/virology , Specimen Handling/instrumentation , Specimen Handling/methods
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