Hospitals do make mistakes, and you still can’t trust your COVID antibody test!

Two brief follow-ups before the weekend starts.

Danielle Ofri, MD.

First, an interesting op ed was published today in the New York Times (you might remember them from yesterday when I found fault with their declaration of “ 36,000 lost souls” based on an unreviewed computer projection). Today they did publish a very nice opinion piece by Dr. Danielle Ofri from Bellevue Hospital in New York

In this piece, Dr. Ofri points out some of the tactics that went wrong in hospitals during the epidemic. They include putting physicians who had little expertise in charge of ventilators, constructing large tent hospitals that were essentially never used, and forgetting to maintain non-COVID healthcare leading to increases in deaths outside the hospital. She also bemoans the loss of the filter provided by peer reviews of science (hopefully the Times reads it own opinion pieces).

All of these are things that could be improved. It is very important that we look carefully at what happened during this first wave of the pandemic so that these mistakes are not repeated, either if coronavirus deaths increase again or when a new pandemic occurs.

COVID antibody test

Another important update involves news around COVID-19 antibody testing. You may remember that antibody tests were being dumped on the US without any validation. The FDA intervened on May 4th and put up new criteria requiring performance data before the tests could be sold. In fact, companies selling these kits under part D of emergency use (without documentation) were required to submit a full application for approval within 10 days or withdraw their product. 

Today, the FDA published a list of the tests that were withdrawn and the ones that remain for sale. Remarkably, 28 antibody tests were withdrawn but 190 other tests are still being sold! The vast majority of these remaining antibody tests do not have full emergency use act (EUA) approval by the FDA and therefore are not validated. This means that the consumer is still at risk for having a test that has not been verified as accurate in the United States.

Published by jbakerjrblog

Immunologist, former Army MD, former head of allergy and clinical immunology at University of Michigan, vaccine developer and opinionated guy.

4 thoughts on “Hospitals do make mistakes, and you still can’t trust your COVID antibody test!

    1. Unfortunately the question is not easy to answer. They blood draw tests are very accurate as long as you are 3-4 weeks out from your infection. Sooner than that they may miss it. Finger sticks are OK from about 8 days out, but vary in quality.

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  1. Teen son, and most of his friends/classmates, were ill in the middle of February. My son had a viral-like illness where his fever spiked over 104 which is very unusual. Lots of fatigue and sore throat. Most of this friend group including my son, saw urgent care doctors where they were tested for Flu A/B & strep. All negative.The doctor thought maybe an adenovirus. We recently followed up with a PCP and he agreed it warranted an antibody test for COVID. It was a blood draw through Quest Lab. The Dr appt and test were fully covered through BCBS. Came back negative. Do you think this test is reliable?

    Liked by 1 person

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