Various lab tests for coronavirus screening! How accurate are these? Doctors demand an answer!
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 a number of such lab tests for coronavirus. 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 USA 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 approve 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 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 on the reliability of the results that they are getting on their patients. They feel that some of the approved tests are not that accurate as they claim to be. The test used in the White House daily to check the suspected cases and contacts are also not reliable!
The tests have a number of false-positive and false-negative reporting. Their specificity and sensitivity is low. This would imply that with false-positive results, many people who are actually not carrying the infection may unnecessarily may isolated and quarantined.
This could add to their misery and economic loss. And 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. Because as communities opened and lockdown is lifted, these people with false-negative results would actually be leading to flare-ups.
What 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,”
“But now that there are plenty of tests out there, it’s time for them to raise the bar.”
FDA has issued a statement that it has asked test developers to do follow-up accuracy tests. There are already 110 approved screening tests currently in 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 spread of infection.