Comparison of Four Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 in Nasopharyngeal Specimens | Journal of Clinical Microbiology

DOI: 10.1128/JCM.00743-20

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TABLE 1
Overview of four molecular in vitro diagnostic EUA assays used in this study^a
↵a BAL, bronchoalveolar lavage; NPS, nasopharyngeal swabs; NS, nasal swabs; OPS, oropharyngeal swabs; TCID₅₀, 50% tissue culture infective dose.
TABLE 2
Summary of limit of detection results
↵a The limit of detection by positive rate for each assay is highlighted in bold.
↵b 95% CI, upper/lower (±) 95% confidence interval.
↵c The final LoD data were determined on the basis of each manufacturer’s results interpretation algorithm.
↵d NA, not applicable.
TABLE 3
Clinical performance comparison of four EUA molecular assays for the detection of SARS-CoV-2 in nasopharyngeal swab specimens (n = 104)
↵a The reference standard was defined as the result obtained from at least 3 of the 4 molecular assays.
↵b Kappa values representing levels of agreement are categorized as follows: >0.90, almost perfect; 0.80 to 0.90, strong; 0.60 to 0.79, moderate; 0.40 to 0.59, weak; 0.21 to 0.39, minimal; (0 to 0.20), none.
↵c ± 95% CI, upper/lower 95% confidence interval.
↵d This one sample had cycle threshold (C_T) values of 38.9 and 39.6 for N1 and N2, respectively, by the CDC assay.
↵e Cycle threshold (C_T) value undetermined.
↵f These two samples had cycle threshold (C_T) values of 36.2 and 38.5 by the Hologic assay.
TABLE 4
Details of discordant sample analysis
↵a Discordant sample results are highlighted in bold. CT, cycle threshold; ID, identifier; NEG, negative; POS, positive.
TABLE 5
Throughput and workflow evaluation for four EUA molecular SARS-CoV-2 assays
↵a NA, not applicable.

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KEYWORDS

molecular diagnostics

real-time RT-PCR

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