FDA approves its first saliva-based COVID-19 antibody test

The FDA approved its first antibody test, which does not use blood samples to check for evidence of COVID-19 infection, but instead relies on simple, painless oral swabs.
The rapid lateral flow diagnosis developed by Diabetomics has received emergency authorization from the agency, allowing it to be used in points of care for adults and children. The CovAb test is designed to provide results within 15 minutes and does not require any additional hardware or instruments.
According to the company, when the body’s antibody response reaches a higher level after at least 15 days after the onset of symptoms, the false-negative rate of the test is less than 3%, and the false-positive rate is close to 1%.
This diagnostic reagent can detect IgA, IgG and IgM antibodies, and has previously obtained the CE mark in Europe. In the United States, the test is sold by the company’s COVYDx subsidiary.
After working to develop a saliva-based test to estimate the weekly blood sugar levels of type 2 diabetes patients, Diabetomics turned its efforts towards the COVID-19 pandemic. It is also working on a blood-based test for the early detection of type 1 diabetes in children and adults; neither has yet been approved by the FDA.
The company previously launched a point-of-care test to detect pre-eclampsia in the first trimester of pregnancy. This potentially dangerous complication is related to high blood pressure and organ damage, but there may be no other symptoms.
Recently, antibody tests have begun to more clearly delineate the first few months of the COVID-19 pandemic, providing evidence that the coronavirus has reached the coast of the United States long before it is considered a national emergency, and it has millions to tens of millions. Of potentially asymptomatic cases have not been detected.
The research conducted by the National Institutes of Health relies on archived and dried blood spot samples collected from tens of thousands of participants.
A study using samples originally collected for the NIH’s “All of Us” population research program in the first few months of 2020 found that COVID antibodies were pointing to active infections across the United States as early as December 2019 (if not earlier) . These findings are based on the American Red Cross report, which found antibodies in blood donations during that period.
Another study that recruited more than 240,000 participants found that the number of official cases as of last summer may have dropped by nearly 20 million. Researchers estimate that based on the number of people who tested positive for antibodies, for every confirmed COVID infection, nearly 5 people are undiagnosed.