When the COVID-19 pandemic hit and spread across the nation, the U.S. Food and Drug Administration granted emergency approval to a plethora of quickly devised tests based on a small number of lab studies. However, top medical experts believe it is time to determine just how accurate they are.
The mass approval was made after FDA was criticized for delaying new tests amid the crisis. Criticism mounted following the Center for Disease Control and Prevention's failure to produce and distribute test kits to multiple states.
In recent weeks, preliminary studies found potential problems with some of the tests, including one used by the White House, the Associated Press News reported. Faulty test results could contribute to flare-ups of the disease as states slowly reopen, leading scientists to demand better evidence of the test's accuracy.
False Positives
The World Link reported a case of a false positive involving a patient at the Bay Area Hospital. The unnamed patient tested positive despite not having a history of exposure or many symptoms associated with COVID-19.
The result surprised healthcare officials, prompting them to order another test using a rapid test kit that detects the virus within 13 minutes or less. The second test, which came out within an hour of the first test, came back negative.
The doctors at the Bay Area Hospital ordered a third test to confirm the negative result. The third test was sent to the Oregon State Public Health Laboratory where the testing equipment had a higher sensitivity rate than the Abbott rapid testing machine used by the hospital.
While the test took longer to process, the hospital announced in a press release that the patient was negative for the coronavirus.
Stricter Regulations
In May, the U.S. FDA imposed stricter regulations on antibody tests to reduce unreliable test offerings in the market. The federal agency now required antibody test makers to seek an emergency use authorization to market their tests, the Wall Street Journal reported.
To get the necessary authorization, the test would have to be 90 percent sensitive to be able to detect antibodies, and 95 percent specific to identify the absence.
However, even with tests that hit those criteria, the chance for false positives can still outmatch true positives if the community infection rate is too low.
For example, a test that is 90 percent sensitive would still pick up 10 false negatives when used to test 100 people.
Health experts fear false positives would cause a person to become less cautious because they believe they have immunity to the virus.
Antibody tests work by gauging the presence of disease-fighting bodies that stay after a patient has been exposed to the virus. Many of the antibody tests came from China and other countries in Asia.
