The BioMedomics COVID-19 IgM-IgG Rapid Test was tested using clinical samples at Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu CDC), Nanjing, China. The COVID-19 IgM-IgG Rapid Test is intended to test IgM and IgG separately. The test was validated against a panel of previously frozen samples consisting of twenty six (26) SARS-CoV-2 antibodies (both IgM and IgG) positive and eighty (80) antibody-negative plasma samples. The antibody-positive samples were collected from clinically-confirmed COVID-19 infected patients and the presence of anti-SARS-Cov-2 antibodies were confirmed with a chemiluminescent IgM and IgG assay (magnetic particles). Within the 26 positive samples, 22 samples tested positive for both IgM and IgG antibodies by BioMedomics COVID-19 IgM-IgG Rapid Test, 4 samples tested positive for only IgG. All 80 negative specimens were collected from healthy donors and confirmed SARS-CoV-2 antibody negative with both the COVID-19 IgM-IgG Rapid Test and the chemiluminescent IgM and IgG assay. Testing was performed using one lot of the COVID-19 IgM-IgG Rapid Test. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008). The results and data analysis are shown in the tables below.

The BioMedomics COVID-19 IgM-IgG Rapid Test displayed a combined sensitivity of 100% (95% CI:86.77%-100%) and a combined specificity of 98.75% (95% CI:93.23%-99.97%).