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Testing was performed by one operator using one lot of the BioMedomics 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 BioMedomics COVID-19 IgM-IgG Rapid Test displayed a combined sensitivity of 96.7% and a combined specificity of 97.1%.COVID-19 testing kits by CTK Biotech!OnSite COVID-19 IgG/IgM Rapid Test. Cat # R0180C. The OnSite COVID-19 IgG/IgM Rapid Test is designed for initial screening by detecting anti-SARS-CoV-2 IgG and IgM antibodies in either human serum, plasma or whole blood within 15 minutes.; This test is easy-to-use, requires only minimally skilled personnel with basic equipment needs. The OnSite COVID-19 IgG/IgM Rapid Test has 97.1% Cellex, INC. qSARS-CoV-2 IgG/IgM Rapid TestThe Cellex, Inc. qSARS-CoV-2 IgG/IgM Rapid Test, which has received an Emergency Use Authorization (EUA) from the U.S Food and Drug Administration (FDA), is indicated for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole blood from individuals suspected of COVID-19 by a healthcare provider.

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