Alarm bells ring over controversial COVID testing
Lawmakers and public health experts are raising alarms about the widespread embrace of blood tests to gauge whether somebody was previously exposed to the coronavirus.
The blood tests have been heralded by state and federal leaders who hope these so-called antibody tests can help guide decisions about when and how to reopen the country by identifying who has been exposed to the virus and may now have immunity even if they have never been diagnosed.
But in the rush to get tests to the public quickly, there are worries that the Food and Drug Administration (FDA) has allowed companies to market tests with little to no oversight, raising the potential for a surge in inaccurate results.
False positives could mislead people into thinking they have already been infected when they have not.
A debate is also being waged about whether these tests currently provide enough useful information in the fight against the pandemic.
A recent report from the House Oversight and Reform Committee found that the FDA allowed a flood of antibody tests on the market without review, resulting in hundreds of flawed tests that are still available for purchase.
The agency has verified and allowed just 10 tests under a formal emergency-use authorization (EUA), while close to 150 are being marketed directly to customers without any review.
Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Oversight and Reform Subcommittee on Economic and Consumer Policy, told The Hill he thinks FDA was under enormous pressure from the White House to get as many tests on the market as possible.
Krishnamoorthi said he wants the agency to clear the market of all the unauthorized tests, but he said they have yet to do so.
“FDA is doubling down on their policies. It’s dangerous … and we’re going to regret that,” Krishnamoorthi said in a recent interview. “If you have a test kit that gives you a false positive, that person might view it as a green light to engage with other people and relax social distancing, and a consequence is they’ll get sick and get others sick.”
Kelly Wroblewski, director of infectious diseases for the Association of Public Health Laboratories, said she thinks FDA officials overcorrected after being criticized for acting too slowly with diagnostic tests, which measure whether somebody is currently infected.
Wroblewski said the FDA has largely been responsive when outside groups have pointed to fraudulent tests, but she hasn't heard from the agency about whether its review process is changing.
On April 17, the FDA told providers about concerns surrounding the antibody tests on the market, saying in a notice that it “does not review the validation, or accuracy, data for these tests unless an EUA is submitted.”
The agency also clarified that antibody tests are not meant to diagnose the disease.
The FDA said it is working with the Centers for Disease Control and Prevention, the National Cancer Institute and the National Institutes of Health to allow test manufacturers to have their products independently assessed for accuracy.
"Performance assessments for serological tests will begin soon, and we expect to start seeing results shortly thereafter," the FDA said.
Leaders are also leaning heavily on the tests to make policy decisions when the science around coronavirus immunity is still unclear.
https://thehill.com/policy/healthcare/495772-alarm-bells-ring-over-controversial-covid-testing