Home News Hype and science collide as FDA tries to rein in ‘wild West’ of COVID-19 blood…

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Hype and science collide as FDA tries to rein in ‘wild West’ of COVID-19 blood…

by Ace Damon
Hype and science collide as FDA tries to rein in 'wild West' of COVID-19 blood...

"Save your business and save lives," says the website Why Health, a Seattle tech startup that sells two types of tests to employers willing to pay $ 350 per pop to find out if their employees have been infected with COVID-19.

The company's "Workplace Health" plan includes not only nasal swab tests to detect infection, but also blood tests to determine whether workers have developed antibodies to the virus – and possibly future protection.

"There is a huge consumer demand," said Lars Boman, medical director of the Boston-based company. “Can they get back to work? Can they come back to life?

What the website does not make clear, however, is that public health officials have explicitly warned that antibody tests should not be used to make decisions about personnel in the workplace.

"This is a personal choice for the business, for the consumer," said Boman.

Across the country, countless numbers of employers, employees and others are turning to a series of new, sometimes expensive blood tests from COVID-19. Knowing who has already been infected can have important implications for understanding the spread of the disease, say the scientists. But serious questions about the accuracy of some of the serological tests (ie, blood) – and the usefulness of the results they provide – have prompted the Federal Food and Drug Administration to try to control what several infectious disease experts have described as “nature wild". , wild west ”of antibody testing.

"It appears that companies have emerged overnight importing and distributing these tests," said Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. "It is outrageous that people are trying to make money from this fear."

More than 200 different tests flooded the market in a matter of weeks, promising to detect antibodies, which are proteins that develop in the blood as part of the body's immune response to an invading virus. They are different from molecular tests, usually done with nasal swabs, used to diagnose infections.

On June 1st, only 15 antibody tests received "emergency use permits" from the FDA, which allow tests that have not yet been fully controlled to be used in a crisis. This pattern has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, who emphasize that they rely on tests that have received FDA approval.

In late May, the FDA removed more than 30 serological tests a list of commercially available kits, saying that they "should not be distributed" for sale. The removal may result from a manufacturer failing to submit an emergency use authorization request within a "reasonable period of time" or if the test shows "significant problems" that cannot or have not been dealt with in a timely manner, the agency said. The mode of execution remains uncertain.

Last month, the CDC issued new guidelines warning that, given the low prevalence of the virus in the general population, even the most accurate tests can be wrong in half the time.

"The results of serological tests should not be used to make decisions about the group of people who reside or are admitted to congregations, such as schools, dormitories or prisons," say the guidelines. "The results of serological tests should not be used to make decisions about the return of people to the workplace."

These tests are more useful for understanding the epidemiology of the virus, not for making individual decisions, said Mary Hayden, director of the clinical microbiology division at Rush Medical Laboratories in Chicago. Even the best tests still do not answer the crucial question of whether antibodies confer immunity to future COVID infections, said Hayden.

"The best possible scenario is for people to be infected and have protective immunity for a long time," she said. “That would be incredible. But we don't (evidence of that) now. "

However, a multitude of tests sent to consumers explicitly promises results that aim to allow them to return to work, school and other social areas.

The tests offered by Why Health are among the hundreds produced since March from a variety of commercial laboratories, academic research centers and small developers looking to participate in the lucrative market spurred by the global pandemic. Because Health is using two antibody tests together, one of which received emergency use authorization on May 29; that authorization for the other is still pending.

Anders Boman, son of medical director and co-founder of Why Health, said that until the COVID-19 crisis, the company launched in Seattle last year was focused on "an integrative care and sexual health niche", including hormonal treatments for men and women.

"Consumers are not concerned with sexual health at the moment," said Boman, explaining the shift in focus. "Are they concerned with how to get back to work, how to get back to normal and are they safe?"

The FDA typically follows a rigorous process of approving tests to detect disease, often an expensive effort that can take months or years. This usually requires validation regardless of the accuracy of the tests. But after being criticized for the clumsy launch of diagnostic tests during the beginning of the current pandemic, the FDA has shifted a lot in the other direction, renouncing its usual requirements and allowing companies to rush self-validated tests on the market.

"They kind of relaxed all regulatory oversight," said Hayden.

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.

"It was really a unique pressure – and that was the fact that the original inability to get a test (diagnosis) on the market in the U.S., as the outbreak increased, means that they were trying to do basically everything they could to achieve that." said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

The relaxed rules attracted concern from Congress, where a subcommittee of the House Oversight and Reform Committee detailed failure of the FDA to "police the testing market". Groups like Assn. Public Health Laboratories also raised questions. Scott Becker, chief executive of APHL, said he spoke to US Department of Health and Human Services officials in early April.

"We just broke free and said, 'This is a very bad policy'," said Becker. "We will be flooded and we will lose control of quality. We will not know what to do with the results."

That's exactly what happened, said Osterholm. "The FDA needs to bring a lot more discipline to this area and needs to articulate it clearly," he said.

An important issue is the accuracy of the tests, which depend on measures known as sensitivity and specificity. A highly sensitive test will capture all true positive results. A highly specific test would identify all true negative results.

In April, researchers at UC San Francisco, led by immunologist Alexander Marson, analyzed 14 serological COVID-19 tests on the market and found that all but one showed false-positive results, indicating that someone had antibodies to the coronavirus when they didn't actually . False positive rates reached 16% in the study, which has not yet been peer-reviewed.

The unreliable results are of concern to Dr. Jeff Duchin, public health officer in Seattle and King County, where the first outbreak of COVID-19 cases in the United States emerged. A person who tests positive for antibodies that do not exist may mistakenly believe that they are free to ignore infection prevention guidelines, potentially spreading the disease. "Regardless of whether you test positive or negative, the workplace still needs to take action," he said. "They shouldn't think that a test program in any way frees them from that responsibility."

FDA officials said they are now working with the National Cancer Institute independently validate serological tests on the market. Until this list is public, users must trust the relatively few who have received emergency use authorizations to date. More than 190 others have applied for this authorization, pending FDA review.

But consumers may have little control, because they are probably receiving tests from their employers or doctors, with little understanding of why these products were chosen.

"There is no national standard, there is no one stop shop or Consumer Reports for antibody testing," said Becker. "I don't expect an audience to be able to find that out."

Even experienced doctors can have problems. US Acute Care Solutions (USACS), a medical owned medical services group, was testing a test made in China, provided by Premier Biotech, based in Minneapolis, with plans to test its team of more than 3,500 doctors and staff, said the head of the group. doctor, Dr. Amer Aldeen. This test has been widely used, including in recent controversial serology research conducted by Stanford University and USC.

When the USACS used it, the Premier test failed to detect antibodies in several employees who were ill and tested positive for coronavirus in diagnostic tests, said Aldeen. The false-negative results could have been caused by failing instructions, rather than failing the test itself, he said. Still, the Premier test was not authorized by the FDA and the results paused.

"It is not good to select a test that is not approved by the FDA," he said.

In a statement, Premier Biotech officials said they anticipated exceeding FDA standards, which require testing with at least 90% accuracy in identifying positive antibodies in a sample and 95% accuracy in identifying samples that do not contain antibodies.

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