Wednesday, April 29, 2020

Coronavirus antibody tests have "really terrible" accuracy, researcher says

Of the 12 antibody tests that were studied by the COVID-19 Testing Project, one of the tests gave false positives more than 15% of the time, or in about one out of seven samples. Three other tests gave false positives more than 10% of the time.
She said while it's unrealistic to think all tests will be 100% accurate all the time, their false positive rates should be 5% or lower, or ideally 2% or lower. 
Bern said one of the reasons for the high false-positive rates is relaxed requirements from the US Food and Drug Administration.
In mid-March, when it became clear that Covid-19 was starting to whirl out of control, the FDA loosened its approval standards in order to get more antibody tests out on the market quickly.
The agency started to allow companies to sell tests without first providing evidence that they worked. Some 175 test developers have taken advantage of these new rules and can legally market their antibody tests without first having their validation data evaluated by the FDA.

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