Beware Fake Covid Tests: How to tell the good from the ugly…
As the world struggles to find the best way to deal with Covid-19, experts agree on one thing: the importance of good testing. Knowing if you have the virus or have had it, recovered and are carrying valuable antibodies to help protect you in the future, can ultimately help everyone move on with their lives in a responsible way. The trick is making sure the test you take, has a high probability of accuracy and is coming from a reputable company authorized to sell it.
A good place to start is checking out those tests that have been authorized by the U.S. Food and Drug Administration’s EUA (Emergency Use Authorization) for use in laboratories certified by CLIA (Clinical Laboratory Improvement Amendments of 1988). Such a test is Biohit’s Sars-CoV-2 IgM/IgG Antibody Test Kit, a rapid laminar flow immuno-assay (LFA) test performed at the point of care facility, giving results within minutes.
In an independent study by a FDA-designated agency using frozen positive and negative antibody serum samples, the SARS-CoV-2 IgM/IgG Antibody Test Kit from Biohit Healthcare was estimated to show a very high IgM and IgG sensitivity (respectively 96.7% each) and as well as a very high specificity (IgM and IgG, each 95%). That is important.
EUA authorization is given only to products that have met FDA’s rigid criteria showing they may be effective in detecting recent or prior infection by identifying individuals with an adaptive immune response to the virus that causes COVID-19 disease.
Unfortunately in this competitive industry some companies claim they have a EUA authorization, when in reality they do not. Companies may also lose their EUA authorizations when tests first submitted have not maintained EUA’s rigorous standards. It is obvious that understanding just which companies have attained EUA authorization for their products is significant when deciding which test to use.
Only four companies, aside from Biohit, have acquired EUA authorization for LFA COVID-19 antibody test kits while more than 16 companies known to have produced serology tests, have not been authorized by the EUA and carry disclaimers such as “Should not be distributed” and “Removed from notifications list.”
Recently FDA Commissioner Dr. Stephen Hahn and Associate Commissioner for Regulatory Affairs Judith McMeekin noted, “The FDA will take appropriate action to protect consumers from bad actors who take advantage of a crisis to deceive the public by marketing tests that pose risks to patient health.”
Dr. James Strader, CEO Bio Testing Supplies adds, “In my discussions with numerous Medical Executives, Government watchdogs and CEO’s of Fortune 500 companies, it is clear that many of them have been burned by fake or faulty tests. It is concerning but it shows the importance of using testing with EUA authorization as well as third party validations like Yale.
“Authorized EUA tests like Biohit can provide invaluable information about active Covid-19 cases and identify those that have acquired antibodies giving them potential immunity and a greater comfort level in resuming more normal lives.”