Posts mislead on recalled COVID-19 test
CLAIM: A COVID-19 PCR test recently recalled for having too many false positive results was the only COVID-19 test available last spring, so its false results exaggerated the scope of the pandemic and fooled Americans into losing their businesses and their livelihoods because of social distancing restrictions.
AP’S ASSESSMENT: False. The Innova Medical Group COVID-19 test featured in recent false posts is an antigen test, not a PCR test, and it was not “the only test available” last spring. In fact, it was never authorized by the Food and Drug Administration for commercial distribution. PCR tests are considered the gold standard for COVID-19 diagnosis and they were used early in the pandemic. By May 2020, the FDA had authorized multiple COVID-19 tests for emergency use, including a different antigen test that has not been recalled.
THE FACTS: A video shared widely on Instagram and TikTok this week falsely suggests that a company’s recall of its COVID-19 test means the coronavirus pandemic is exaggerated.
The video shows a narrator in front of a screenshot of the FDA website. The screenshot shows a notice about the June recall of a rapid antigen test by Innova Medical Group. The company recalled the test after the FDA found it risked giving false results. It also was not approved, authorized or cleared by the FDA for commercial distribution.
“America should be pissed off right now,” the narrator says. “The FDA announced that the PCR COVID-19 test has failed its full review. Its emergency use authorization has been revoked. It is a Class I recall, which is the most serious of recalls, because of too many false positives. This is the test that started the pandemic. This was the test used in all the nursing homes in Washington and New York. This was the only test in use in May of 2020. And no one can be sued because it wasn’t FDA approved. Congratulations, you didn’t listen to us, and you’ve all been fooled into losing your businesses and your livelihoods, because of a lie.”
The narrator’s words don’t match the text in the screenshot describing the recalled test, which is an antigen test and not a PCR test. PCR tests detect the genetic material of the virus and are considered the most sensitive type of test. Antigen tests are rapid tests that are less sensitive and look for proteins called antigens on the surface of the virus.
Innova Medical Group’s recalled antigen test also was never authorized by the FDA, while many other antigen tests and PCR tests have been. FDA spokesperson Jim McKinney told The Associated Press that a different test, the Quidel Sofia 2 SARS Antigen FIA, was the first antigen test it authorized for COVID-19, on May 9, 2020.
The AP recently debunked another claim related to COVID-19 tests, which sprung up after the Centers for Disease Control and Prevention withdrew its request to the FDA for Emergency Use Authorization for one early PCR test. The CDC withdrew its request voluntarily not because it was inaccurate, but because it could only detect COVID-19. Newer tests can test for COVID-19 and influenza at the same time.
The COVID-19 pandemic has claimed more than 600,000 lives in the United States and more than 4 million globally, according to Johns Hopkins University.
This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.