In major breakthrough, FDA approves Covid-19 antibody test

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If you are getting depressed and fatigued from all the bad news out there, this new item should cheer you up. The FDA has approved an “antibody” blood test for the coronavirus.

The purpose of the antibody test is to determine if a person has been exposed to coronavirus in the past. It is not designed to test if a person has coronavirus, but a test to determine if a person had coronavirus. This provides scientists with more data and more options to develop treatments for patients battling coronavirus.

What are antibodies?

According to The Conversation: Antibodies recognize and bind proteins on the surface of virus particles. For each infection, the immune system designs antibodies that are highly specific for the particular invading pathogen.

Why is that important?

  •  Testing people to determine how many have had the virus, will provide more accurate numbers of the people that have had the virus and recover. Those numbers will impact the rate of death to the rate of infection numbers. This information will help the government and the medical community to scale their response to the virus.
  •  Antibody testing will provide more data for scientists to study whether a person that has had the virus is immune to or is still a carrier of the virus. It is not yet known how long after a person recovers the virus might still be present, but those studies are being done both here and in other countries.
  • By identifying people that have had the virus and recovered, scientists can develop blood plasma treatments using blood donated by individuals with the coronavirus antibodies present to fight the virus. Those treatments can then be used to help infected people battle the coronavirus.

Blood plasma treatments

Blood plasma can be an important tool in fighting the coronavirus. It can be used to treat those who are already sick and it can be used to prevent the virus in those who are repeatedly exposed to the virus e.g. healthcare workers, doctors, nurses, and first-responders. And this

Blood plasma or “convalescent plasma” treatments have been used for over a hundred years in this country. According to Wayne A. Marasco of the Dana-Farber Cancer Institute in Boston:

Convalescent plasma has a real role — this has been going on for over 100 years. We know this stuff works. If you do this right and harvest plasma from someone who has undergone infection, you can get protective antibodies that can be infused in other people.”

FDA emergency use authorization

The FDA has approved the Cellex Inc. antibody test under the emergency use authorization.

From FDA.gov on April 2:

To date, 25 emergency use authorizations have been issued for diagnostic tests. Notably, the FDA issued an emergency use authorization, on April 1, 2020, to Cellex Inc.’s qSARS-CoV-2 IgG/IgM Rapid Test which is the first serology test to date to receive authorization to test for the presence of coronavirus antibodies. Cellex’s labeling notes that test results from this serology test should not be used as the sole basis for diagnosis and can only aid in the diagnosis of patients in conjunction with a medical review of symptoms and results of other laboratory tests. Cellex’s test is also limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests.

FDA chief Dr. Stephen Hahn explains the new test:

Dr. Deborah Birx  of the White House Coronavirus Task Force, explains the use of the antibody test as part of the plan to get ahead of the coronavirus:

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