People without symptoms of COVID-19 who haven’t been exposed to the virus shouldn’t get rapid tests to see if they are infected, according to guidance Friday from the Food and Drug Administration.
The guidance, added to the agency’s website, says that instead, highly sensitive tests, known as PCR tests, should be used for such individuals — if turnaround times are fast enough. These lab-based tests are known to be more accurate, but take hours to complete. Recent backlogs across the country have left some people waiting upward of 10 days for results.
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“This is a sound strategy and is generally how these tests have been promoted by the FDA,” said Dr. Joseph Petrosino, director of molecular virology and microbiology at Baylor College of Medicine. “It is not, however, how I’ve seen them used in some settings.”
Rapid or point-of-care tests, which take just minutes to run and are done in a doctor’s office, have come under fire in recent weeks because they are typically not as sensitive and may give false negatives.
According to the new guidance, if rapid tests are being used and patients test negative, then doctors should consider adding a different test or collecting new samples on a different day to confirm the results.
“The general concern here is that the cost of rapid tests are generally no lower than PCR, so it gets expensive to repeat test people,” Petrosino said. “I think we will see some new tests soon that are more cost effective on the rapid test front that can help change the game here.”
The guidance comes at the same time that the Trump administration is pushing for more rapid testing. In an interview last week with NBC News medical correspondent Dr. John Torres, the administration’s testing czar, Dr. Brett Giroir, said that there would be 23 million rapid tests on the market by September.
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August 15, 2020 at 02:32AM
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