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

​Accuracy: Sensitivity & Specificity

IgG test

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.


IgM 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).