The FDA is allowing the Anytime Covid Test Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. As required, the completed template and associated documentation were submitted on May 5, 2020 and are waiting feedback from FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. FDA Clinical Trials Number NCT04402814. Clungene’s establishment registration & device number on the FDA’s website is 3009414546
NO TEST IS 100% ACCURATE
Accuracy: Sensitivity & Specificity
Sensitivity = 97.40%
Positive Agreement with PCR Testing
Testing of Coronavirus Disease (COVID-19) in healthcare workers using SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test.
Sensitivity = 87.01%
Positive agreement with PCR testing
Specificity = 98.89% Ability to correctly identify negative cases
Accuracy = 93.41% Ability to detect IgM or IgG
Evaluation of SARS-Cov2 Virus IgG/IgM rapid test cassette Clungene® test with RT-PCR testing in inpatients with COVID-19 for the detection of antibodies (IgG and IgM).