Serological chemiluminescence immunoassay for the diagnosis of SARS-CoV-2 infection

Journal of Clinical Laboratory Analysis
Shao LijiaWu Junqi

Abstract

Dynamic monitoring of the concentration variation of IgM and IgG in patients with SARS-CoV-2 infections and exploring their diagnostic value for coronavirus disease-19 (COVID-19). A total of 15 patients with SARS-CoV-2 infection were enrolled as the COVID-19 group, and 50 patients were enrolled as the control group. The concentrations of SARS-CoV-2-specific antibodies (IgM and IgG) were detected by a chemiluminescence immunoassay (CLIA). According to the cutoff value recommended by the manufacturer (cutoff = 10 AU/mL), the sensitivity, specificity, Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV) of IgM were 60%, 100%, 60%, 100%, and 89.29%, respectively; and 86.67%, 100%, 86.67%, 100%, and 96.15%, respectively, for IgG. We reassessed the cutoff value of IgM. When the cutoff value for SARS-CoV-2 IgM was 1.83 AU/mL, the sensitivity, specificity, YI, PPV, and NPV were 93.33%, 98%, 91.33%, 93.33%, and 98%, respectively. During dynamic monitoring of the concentrations of IgM and IgG in COVID-19 patients, we found the shortest times before a patient became IgM and IgG seropositive after symptom onset were 1.5 and 2 days, respectively. The longest times were 7 and 8 days, respectively. The posit...Continue Reading

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Methods Mentioned

BETA
reverse transcription PCR
nucleic acid extraction

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