The Antibody Tests are Coming | Citizens Against Government Waste

The Antibody Tests are Coming

The WasteWatcher

There has been a lot of talk about all the COVID-19 tests that are being developed.  One type of test is diagnostic and tells the physician if a patient has the coronavirus, or SARS-CoV-2.  Those tests are being used now and continue to be developed.  The other test will determine if you have been exposed to the virus but are no longer sick or were asymptomatic and your blood has developed antibodies to fight the virus.  These tests will also help in the development of vaccines.

White House Coronavirus Task Force Coordinator Deborah Birx, MD answered a reporter’s question about antibodies at an April 1 press conference with a challenge to our nation’s researchers.  She asked them to develop a test that could tell healthcare workers and others that they had already been infected, that they have the antibody to fight the coronavirus, and they are safe from re-infection at least 99.9 percent of the time.  She said that kind of test could be developed by the end of the week.

That challenge had already been underway.  That very day, the Food and Drug Administration (FDA) gave Cellex, Inc. the first emergency use authorization (EUA) for a serological test.  It is a qualitative test for the detection of IgM and IgG antibodies against the SARS-CoV-2 in serum and plasma.  The body creating antibodies is a normal human response to fighting an antigen, like a virus.  IgM antibodies are created at the start of the infection and IgG antibodies are detected following the infection and protects the body from being re-infected.  If both antibodies are detected at the same time, it suggests an acute or recent infection.

Two weeks earlier, on March 16, the FDA updated their policy to encourage the rapid development of serological tests.  If the test has been validated, the manufacturer has notified the agency, and that their kits include warning statements the product has not been reviewed by the FDA, they can distribute the tests to labs while seeking a EUA.

BD and BioMedomics also had a new test that can detect present or past exposure to the coronavirus within minutes.  Because the test is being dispersed per the March 16 FDA policy, it is labeled as not yet approved by the agency and cannot be used as the only assessment to determine a diagnosis.

These tests demonstrate the ability of our nation’s biomedical industry and the government cutting red tape to get results.  The importance of these serology tests cannot be understated.  These kits will be needed to understand more clearly how far the virus has spread, who had no symptoms even though they were infected by the virus, and to get an accurate picture of its lethality.  And there is no doubt these test kits and the ones that will rapidly follow are part of the discussion on how and when America gets back to work. 

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