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FDA Gives Emergency Approval To COVID-19 Antibody Test That Boasts Near-Perfect Accuracy

The FDA (Food and Drug Administration) has given an emergency approval to a coronavirus antibody test that boasts near-perfect accuracy.

The announcement was made on May 3, 2020.

Roche, a Swiss Drugmaker, said that the new test, which determines whether someone had a past infection, has proven 100 percent accuracy at detecting antibodies in the blood.

Not only that, but the tests also have 99.8 percent accuracy at ruling out the presence of them.

The company said that the test requires intravenous blood draws, with higher accuracy than the finger prick test.

Thomas Schinecker, the company’s head of diagnostics, released a statement about the test.

Thomas said:

If you take blood from a finger prick, you will never be able to achieve the same level of specificity that you will achieve … when you take blood from the vein. You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.

Schinecker said that the tests are an important step in determining if someone has immunity to the deadly virus.

Thomas added:

Since this virus is not well known, one can hypothesize, but the proof will take longer. Testing these people … is key to seeing whether or not people really have developed immunity.

One step at a time.