Analytical Performance of Rapid Nucleic Acid Detection Assays and Routine RT-qPCR Assays for Detection of SARS-CoV-2 in Shanghai, China in 2022

Elsevier

Available online 12 November 2022, 115860

Diagnostic Microbiology and Infectious DiseaseABSTRACT

Diagnostic accuracy of COVID-19 varies among different assays. In this study, the analytical performance of one rapid nucleic acid detection assay (Coyote assay) and two routine RT-qPCR assays (BioGerm assay and DaAn assay) was evaluated, using 1196 clinical samples. Disagreement in the results of two paired targets occurred in all three assays. The Coyote assay failed to detect 15 samples, and the DaAn assay failed to detect 5 samples. The Cohen's kappa coefficient was 0.970 between the BioGerm and DaAn assays, 0.907 between the Coyote and BioGerm assays, and 0.936 between the Coyote and DaAn assays. The positive percent agreement (PPA), and negative percent agreement (NPA) of the Coyote assay were 84.04%, and 100%, respectively. Our study revealed that the results of the Coyote, BioGerm, and DaAn assays were highly consistent, which provided reference for the application of these assays for diagnosis of COVID-19.

Keywords

COVID-19

SARS-CoV-2

RT-qPCR

rapid nucleic acid detection

analytical performance

AbbreviationsNAD

nucleic acid detection

NPA

negative percent agreement

NPV

negative predictive value

PPA

positive percent agreement

PPV

positive predictive value

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