F.D.A. Approves First Coronavirus Antibody Test in the U.S.
In a first for the United States, the FDA is giving emergency use authorization for an antibody test for the coronavirus. So, if you’ve had symptoms of COVID-19, but were unable to get tested, a new product could help you determine if you’ve had the virus. I’m really excited about this new test because it should really help with our fight against coronavirus.
New Test by Cellex
The company producing this new test is a biotech company called Cellex. Now, ‘emergency use authorization’ means the test has yet to gain full approval, but they’re allowing it to be used anyway. Here’s why:
- The FDA believes the test will be effective
- No approved alternatives exist
- The potential benefits outweigh the risks
The test works by looking for two types of antibodies in a blood sample. Samples are taken to authorized labs for testing that takes about 15 – 20 minutes to complete. There, the blood is analyzed for immunoglobulin M – an antibody our bodies make when responding to a foreign substance, and immunoglobulin G – an antibody our bodies make if we’re infected with the coronavirus. If you test positive, it indicates you currently have the infection or that you were recently infected.
Other Testing Methods
The current test being used is called a PCR test. This test works by looking for small pieces of the virus itself and is administered with a nose or throat swab. This test is more likely to detect a new infection. For the test made by Cellex, it’s possible to test negative if you’re tested too early. This is because antibodies take some time to develop. So there is a downside to this new test.
While this new test would show if someone has antibodies, it wouldn’t show how well they are working. So, while it’s likely that you would have some immunity, there is no guarantee of full immunity. And, even if you have some immunity, there’s no telling how long that will last.
What this would be helpful for, however, is determining how many people have been infected and therefore how deadly the virus actually is. It would also be extremely useful for frontline healthcare workers and my colleagues. If they’ve already been infected, they could be assigned to work with coronavirus patients with presumably less risk than someone who hadn’t. Now, they’ll still need proper protection and equipment to do their jobs because we don’t yet know if someone can be re-infected with coronavirus. But it may provide some peace of mind to know you have antibodies while working on the front lines.