COVID-19 Tests. We Must Proceed With Caution

COVID-19 Testing. It’s a featured topic on 60 Minutes in late June, 2020 and their investigative journalism has some surprising discoveries about how the FDA allowed antibody tests of varied accuracy onto the market.

“The wonderful, beautiful immunity.”  That’s how the President described antibody protection in folks who have recovered from COVID-19.  We know that the virus causes illness with varied symptoms and severity, and many infected people have recovered.  Tragically, many have not.  As of July 1, 2020 according to Johns Hopkins surveillance figures , there have been 10 million confirmed infections in the world, and half a million people have died.  But who are the 9.5 million who have recovered?

For those who had fever and upper respiratory symptoms this spring, it’s possible (but not likely) that your viral infection was actually COVID-19.  In an effort to figure out who has recovered from COVID-19 and already has that “beautiful immunity” that might mean you might be protected from another infection this winter, the FDA allowed many companies to develop and sell antibody tests as quickly as possible.  Our practice worked with one such distributor of antibody tests.  While we researched the value of screening our patients for COVID-19 immunity early in the pandemic, the company we were working with changed course and chose not to sell their kits without FDA approval. And 60 Minutes arrived on the scene.

We concur with the concerns of the investigative journalists at 60 Minutes who discovered widely variable accuracy for the different brands of antibody tests.  The FDA allowed countless antibody test kits to flood the market after asking only that the companies self-validate their product.  This is a little like asking the Fox in the henhouse to do quality control, and the unprecedented decision created “an Anything Goes Wild West approach” to COVID-19 testing according to 60 Minutes.   Without reliable accuracy, the chance of false positive or false negative results might give misleading information to patients.  So we put our early testing on hold.  Learn more about why by watching the 60 Minutes full expose HERE or watch the abbreviated version below.

The deeper dive to understand COVID-19 testing can be found in these reliable resources:

Check back for future updates on Coronavirus testing as the weeks go by.  We want our readers to feel like they understand and have a handle on the complexity of the disease and what doctors and scientists are doing to help fight the pandemic.

Gayle Schrier Smith, MD

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