• It has been almost 7 months since coronavirus hit Earth.
• Various tests to screen and diagnose the infection are ongoing worldwide and in the USA to pick up patients/carriers and isolate them.
• USA FDA rapidly approved several such lab tests for coronavirus.

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But how reliable are the tests? Doctors and scientists feel that it is high time that we have a re-look at these tests and know how effective they have been in picking up cases reliably.

Lab tests for coronavirus infection

As soon as coronavirus struck the world, scientists started developing tests to screen and diagnose the infected cases. Many labs around the world conducted tests on a small number of patients and concluded that they have a reliable test to pick up patients or carriers of coronavirus infection.

Considering the urgency of the situation and the dire need for a test, the US FDA too gave approvals to these tests based on their small sample studies.

Normally, large population studies with the claimed test are a prerequisite to approving them for marketing purposes.

But now, in retrospect, doctors from top medical centers feel that many of the tests may not be all that reliable. They feel that the FDA needs to review the various tests it approved earlier and grade their accuracy.

Problems with the lab tests for COVID-19

In recent weeks, doctors have raised doubts about the reliability of the results that they are getting on their patients.

They feel that some of the approved tests are not as accurate as they claim to be. The test used in the White House daily to check the suspected cases and contacts is also not reliable!

The tests have several false-positive and false-negative reporting. Their specificity and sensitivity are low. This would imply that with false-positive results, many people who are not carrying the infection may be unnecessarily isolated and quarantined.

This could add to their misery and economic loss. On the other hand, when the results are false-negative, active cases of coronavirus would be out in contact with unexposed people and spreading the virus to them.

This is a very precarious situation. As communities open and lockdown is lifted, these people with false-negative results would be leading to flare-ups.

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What do experts state?

Dr. Steven Woloshin of Dartmouth College wrote recently in the New England Journal of Medicine:

“In the beginning, the FDA was under a lot of pressure to get these tests onto the marketplace,”

Steven added:

“But now that there are plenty of tests out there, it’s time for them to raise the bar.”

FDA has stated that it has asked test developers to do follow-up accuracy tests. There are already 110 approved screening tests currently on the market.

FDA has assured that from its side, it is tracking those problematic reports. This would help in cutting down on unneeded misery and also prevent the spread of infection.

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