Evaluation of the diagnostic performance of Coronavirus (SARS-CoV-2) IgM/IgG rapid Test Kit in subjects with Sars-COV-2 PCR test results, and disease-free subjects with clear free-ofexposure evidence to the Sars-COV-2 virus, or showing no symptoms of COVID19 in 3 weeks or more after sample collection.
Coronavirus (SARS-CoV-2) IgM/IgG rapid Test Kit
Blinded and/or controlled diagnostic test study with parallel reference test.
The reference standard was established as fulfillment of one of three criteria as following:
There are two secondary endpoints in this study.
The sensitivity of IgM and IgG tests combined against reference standard in overall study population is 90.44% (123/136, 95%CI: 84.21-94.81%).
The specificity of IgM and IgG tests combined against reference standard in overall study population is 98.31% (1044/1062, 95%CI: 97.33-98.99%).
The accuracy of IgM and IgG tests combined against reference standard in overall study population is 97.41% (1167/1198, 95%CI: 96.35-98.24%), with Kappa value of 0.8735.
The sensitivity of IgM against reference standard in overall study population is 61.03% ( 83/136, 95%CI: 52.3-69.27%).
The specificity of IgM against reference standard in overall study population is 98.42% (1058/1075, 95%CI: 97.48-99.08%).
The accuracy of IgM against reference standard in overall study population is 94.22% (1141/1211, 95%CI: 92.75-95.47%), with Kappa value of 0.6722.
The sensitivity of IgG against reference standard in overall study population is 63.24% ( 86/136, 95%CI: 54.55-71.33%).
The specificity of IgG against reference standard in overall study population is 99.91% (1061/1062, 95%CI: 99.48-100%).
The accuracy of IgG against reference standard in overall study population is 95.74% (1147/1198, 95%CI: 94.44-96.81%), with Kappa value of 0.7491.
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