A coronavirus test used across the county may have an accuracy problem. The FDA has issued a warning that the test made by Abbott Laboratories can produce false-negative results.  So just how inaccurate is this test?

False-negative results are very concerning, because it means that a patient is told that they are not infected with the coronavirus when in fact they actually are.  So how inaccurate is this test?  Well, a recent study by researchers at NYU Langone Health in New York found that this test could be missing up to 48% of infections.  So it’s no surprise that these researchers are calling the Abbott test “unacceptable”.

The Cause of the Problem

The Abbott test is fast, it can give results within 13 minutes.  Which is one of the reasons why it’s used at over 1,000 locations across the US.  But speed was not mentioned as one of the potential reasons for it’s high inaccuracy.  Instead, the FDA has said that the inaccurate results could be because of the types of swabs that are used, or it might be the material that’s used to transport samples from patients.   Now, Abbott Laboratories, the company that makes the test is disputing the findings.  They’ve said that some researchers are storing samples for too long.  And if the sample becomes too diluted, it can then affect testing performance.

What’s Next?

According to the FDA, the Abbott test can still be used.  Because it’s fast and identifies positive cases in a short period of time. But the FDA is suggesting that negative results be confirmed with another test, possibly by a “high-sensitivity authorized molecular test”.  Especially if a patient has clinical signs and symptoms of COVID-19 but tested negative.  In the meantime, the FDA will continue to investigate and review data on the Abbott test.  And they are working with the company who has agreed to partake in future studies to show just how accurate their ID NOW test is.  And these studies will take place in different clincial settings and at least 150 patients who are COVID-19 positive will take part.