FDA gives emergency approval to coronavirus antibody test with 100% accuracy claim

Tribune Content Agency

The Food and Drug Administration gave emergency approval to a coronavirus antibody test that has 100% accuracy, according to its Swiss manufacturer.

According to drugmaker Roche, their antibody test has an incredible success rate when determining whether or not someone has been infected with coronavirus. The test was 100% accurate in finding antibodies (evidence of a past infection) and 99.8% accurate in determining the lack of such antibodies.

The company said the test draws blood intravenously, which is more accurate than other methods of drawing blood.

“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,” Thomas Schinecker, the company’s head of diagnostics, said.

“You have to have very, very high specificity. Even 0.1% or 0.2% makes a difference.”

Schinecker said, however, that the presence of antibodies does not necessarily mean that someone is immune from being reinfected and that more research on the topic was desperately needed.

The company said it would be manufacturing tests in the “high double-digit millions per month.”

Several other companies, including Abbott Laboratories, Becton Dickinson and Co, and Italy’s DiaSorin, have also received emergency approval from the FDA.

Meanwhile, the House Oversight Committee has asked the FDA to clear faulty antibody tests out of the market since a false positive or negative could increase the risk of infection.


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