The head of Johnson County's health department this week publicly dispelled a frequently-repeated rumor that all COVID-19 polymerase chain reaction tests — the type of test used to most accurately confirm infection — had been recalled.
It's not true, said Sanmi Areola, director of the Johnson County Department of Health and Environment.
His comments come after several community members and a county commissioner repeatedly and incorrectly asserted that all PCR tests had been recalled because of false positives. They made those claims during Johnson County Commission meetings over the last few weeks.
Areola said the misconception likely emerged because people didn’t read the whole report before making assumptions.
“It's like cutting out the sentence and making deductions at the first phrase without reading the full sentence,” he said.
WHAT’S HAPPENING WITH THE FDA AND COVID-19 TESTING?
In June, the Food and Drug Administration in the U.S. released a medical device recall for the Innova SARS-CoV-2 Antigen Rapid Qualitative Test. The results from this test were returned more rapidly than the standard PCR test but with less accurate results. It only affects devices distributed between Nov. 2, 2020 and March 22, 2021.
Antigen tests are not the same as PCR tests. A PCR test detects genetic material of a known virus. Such tests have been used for years to confirm infection for several illnesses, including the flu. An antigen test just detects proteins associated with the virus.
The recall can be viewed here.
“The test used a nasal swab sample and test strip to detect specific proteins, called antigens, from the SARS-CoV-2 virus,” the recall reads.
The Innova antigen test isn’t the only to be recalled. In May, the Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test and Leccurate SARS-CoV-2 Antibody Rapid Test kits were also recalled because they could produce false results. Neither of these tests ever received authorization or approval from the FDA.
Another test — this one a PCR test — was also recalled in July because of a “significant risk” or returning false negatives, according to another FDA recall statement. This test, Lyra SARS-CoV-2 Assay test, was distributed between March 17, 2020 and May 27, 2021.
The risk with this test, Areola said, was that it could “undercount” infections, not “overcount.”
“There's a component of it that could potentially cause the positive results to be negative,” he said.
HOW DOES THE PCR TEST RELATE TO THE FLU?
Something else that might be confusing people is that the FDA replaced the original emergency use authorization for the COVID-19 PCR test with one that simultaneously tests for SARS-COV-2 as well as Influenza A and B. This does not mean that the common test couldn’t distinguish between the different viruses, but that it was only testing for COVID-19.
“The current PCR test that we've used thus far is optimized for identifying the virus that causes COVID-19,” Areola said. “If it's not the virus, it doesn't identify that. … The impression that it's been withdrawn because it's picking up things that are not COVID-19 — that’s inaccurate, that’s wrong.”
OTHER MISCONCEPTIONS AND MYTHS
Areola also tried to knock down other myths and misinformation during the Johnson County Commission meeting this past week.
He addressed the assertion that the drug Ivermectin, which is an antiparasitic, is an effective treatment of COVID-19. He said that is false.
In the U.S., it has not been approved as a treatment for viral infections like COVID-19, according to the National Institutes of Health. Ivermectin is approved by the FDA for the treatment of diseases, such as scabies and river blindness, caused by parasites.
“Ivermectin is often used in the U.S. to treat or prevent parasites in animals,” the FDA reported. “The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with Ivermectin intended for horses.”
Other drugs, like Remdesivir, do have FDA approval for treatment of COVID-19 in hospitalized patients over age 12. Unlike Ivermectin, Remdesivir is an antiviral medicine.
Additionally, Areola said the belief that the SARS-COV-2 virus has not been isolated in a laboratory is false.
“It has been isolated in many laboratories across the world,” he said. “We even have pictures of it taken from electron microscopes.”
The genome has also been parsed out. In fact, that happened very early in the pandemic. The viral genome can be downloaded from the NIH’s National Library of Medicine. If the virus hadn’t been isolated, it would be impossible to accurately test for it.