Salivary-based COVID-19 Antibody Test Gets FDA Approval

The FDA has granted emergency use authorization (EUA) for its first antibody test that doesn’t use blood samples but rather uses mouth swabs. This saliva-based COVID-19 antibody test, called CovAb, has been developed by Diabetomics. This rapid diagnostic test can be used for both adults and children and delivers the result within 15 minutes. The test detects IgA, IgG, and IgM antibodies. According to the studies, when tested 15 days after the onset of COVID-19 symptoms, the test showed a false-negative rate of less than 3% and a false-positive rate of less than 1%.

Diabetomics Inc. is a global medical diagnostics company that develops innovative, non-invasive point-of-care tests. It has pioneered a finger stick blood test for detecting preeclampsia during the first trimester of pregnancy. They are also in the process of developing a saliva-based test for estimating weekly glucose levels in Type 2 diabetics, and a blood-based test for early detection of Type 1 diabetes. Most recently they switched their efforts to develop the CovAb with the onset of the COVID-19 pandemic.