No, CDC has not issued an ’emergency recall’ of COVID testing

False allegations circulated on Twitter, Facebook and Instagram this week that the CDC and the FDA had “admitted” that PCR tests – which examine the genome of a virus to determine which strain it is – to COVID do not work. This is completely wrong.

CLAIM: Centers for Disease Control and Prevention revoked emergency use authorization for coronavirus PCR tests because they were inaccurate, led to false positives, and confused positive influenza cases with COVID- 19.

THE FACTS: The claim is wrong. The CDC is taking action to phase out a coronavirus test that was developed at the start of the pandemic, not because of inaccurate results, but because new tests can simultaneously test patients for the flu.

The FDA has approved approximately 280 polymerase chain reaction or PCR tests, which determine whether sequences of the virus’s genome are present in a patient’s nasal swab. At the start of the pandemic, in February 2020, the CDC introduced a PCR test for coronavirus, known as the “CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel”.

July 21, the CDC announced that after this year, it would no longer seek emergency use clearance from the FDA for this test, which means labs will stop using it.

Kristen Nordlund, health communications specialist at the CDC, told The Associated Press the agency made the move because new PCR testing options now exist.

“The CDC 2019 novel coronavirus real-time RT-PCR diagnostic panel (2019 nCoV) has addressed a significant unmet need during its development and deployment and has not demonstrated any performance issues,” said Nordlund . She said the agency was encouraging labs to switch to tests capable of detecting influenza at the same time, as that “would save time and resources.”

But social media users misinterpreted and distorted the ad. False claims have circulated that the CDC’s ruling meant the agency and the FDA had admitted that PCR tests were not working.

Some articles online have falsely stated that the test was unable to differentiate the coronavirus from the flu, leading to an increase in the number of COVID-19 and a drop in the number of influenza.

In fact, PCR tests are designed to detect very specific areas of the viral genome, so as not to confuse the tests between which virus is present, said Matthew Binnicker, director of the clinical virology laboratory at the Mayo Clinic in Rochester, Minnesota. .

“PCR tests, including the one developed by the CDC, are very accurate and are able to tell the difference between SARS-CoV-2 and influenza,” Binnicker said. “In other words, a COVID-19 test won’t be positive if a person really has the flu, and vice versa.”

Binnicker said there are benefits to having a single test that can detect both viruses, as the symptoms of the two diseases are often similar at first. Additionally, neither the CDC nor the FDA have questioned the effectiveness of PCR technology.

“PCR tests are generally considered the ‘gold standard’ for diagnosing COVID-19,” said James McKinney, FDA press secretary.

– Associated Press editors Terrence Fraser in New York and Jude Joffe-Block in Phoenix contributed to this report.