Hype clashes with science as FDA tries to curb the “wild west” of COVID-19 blood tests | Coronavirus

“Save lives and save businesses,” says Seattle Health’s website, Cause Health’s website, says employment wants $1350 to find out if workers are infected with COVID-19 Mainly sold.

The Workplace Health plan includes a nasal swab test to detect infections, as well as a blood test to show if the worker has developed antibodies to the virus.

“There is a great demand for consumers,” said Dr. Lars Bowman, medical director of the Boston-based company. “Can they get back to work? Can they come back?”

However, the lack of clarity on the website is that public health officials have clearly warned that antibody testing should not be used to make decisions about workforce staffing.

“This is a business, consumer personal choice,” said Bowman.

In the United States, countless employers, employees, and the general public are turning to many new and sometimes expensive COVID-19 blood tests. Knowing who is already infected can be important in understanding the spread of the disease, scientists say. However, with serious questions about the accuracy of some serological tests, and the usefulness of the results they provide, the Federal Food and Drug Administration has identified some infectious disease specialists as “wild, wild west,” I tried to suppress what I explained. Antibody test.

Dr. Michael Bush, director of the San Francisco Non-Profit Vitalant Laboratory, said: “It’s ridiculous that people were trying to make money from this fear.”

Over 200 tests flooded the market within a few weeks, promising the detection of antibodies, proteins that occur in the blood as part of the body’s immune response to invading viruses. These are different from the molecular tests used to diagnose infections, which are usually done with nasal swabs.

As of 1 June, only 15 antibody tests received the FDA’s “Urgent Use Permit”. This allows under-tested tests to be used in crisis. Even that standard has become a selling point for some large companies such as LabCorp and Quest Diagnostics, emphasizing their reliance on FDA-approved testing.

In late May, the FDA removed more than 30 serotests from its list of commercial kits and sold it as “don’t distribute.” Deletion caused by manufacturer’s failure to submit an emergency license request within a’reasonable period’, or if testing indicates a’serious problem’ that could not be addressed or could not be addressed in a timely manner It is considered. The method of enforcement remains unclear.

Last month, the CDC announced a new guideline warning. Given the low prevalence of the virus in the general population, even the most accurate tests can be wrong in half the time.

“You should not make a decision about using serology results to group people who live or reside in schools, dormitories, correctional facilities, etc.,” the guidelines say. “Serologic test results should not be used to make decisions about returning a person to work.”

Dr. Mary Hayden, head of clinical microbiology at Rush Medical Laboratories in Chicago, doesn’t say such tests are most helpful in understanding the epidemiology of the virus and help make individual decisions. Hmm. Even the best tests still can’t answer the key question of whether antibodies confer immunity to future COVID-19 infections, Hayden said.

“The best scenario is that people get infected and they have protective immunity for a long time,” she said. “It’s great. But for now it’s not.”

However, numerous tests being marketed to consumers clearly promise results aimed at enabling return to work, school and other social spheres.

Why Health offers tests ranging from those provided by commercial laboratories and academic research centers to small developers seeking a foothold in a profitable market that has spurred a global pandemic, starting in March and ending in the hundreds. It extends. Health has two antibody tests in parallel, so one of them received an emergency license on May 29. The other is still pending.

Anders Boman, son of medical director and co-founder of Cause Health, said the company launched last year in Seattle until the COVID-19 crisis, “integrated care and sexual health niche, with men. Includes hormone treatments for women.

“Consumers aren’t currently worried about their sexual health,” Bowman said, explaining the shift in focus. “They are worried about how to get back to work, how to get back to work, are they safe?”

The FDA usually follows a strict approval process for tests to detect disease. This is often an expensive task that can take months or years. To do this, it is usually necessary to individually verify the accuracy of the test. However, after being accused of flashy development of diagnostic tests during the beginning of the global pandemic, the FDA abandoned the usual requirements and sent companies self-validation tests to the market.

“They eased a kind of regulatory oversight,” Hayden said.

Some of the experts interviewed by Kaiser Health News said the FDA is facing significant political pressure to make antibody testing available.

“It was really a single pressure. And that it couldn’t get a (diagnostic) test in the US market when the outbreak escalated could basically help them solve these. It was the fact that he was trying to do everything,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.

The relaxed rules have raised concerns from Congress. In parliament, a subcommittee of the Commission on Oversight and Reform elaborated on the FDA’s “test market crackdown” failure. Groups such as the Association of Public Health Laboratories have also raised issues. APHL CEO Scott Becker said he spoke with executives at the US Department of Health and Human Services in early April.

“We just let go and said, “This is a really bad policy,” said Becker. “We will flood and lose control of quality. We don’t know how to handle the results.”

That’s exactly what happened, Osterholm said. “The FDA needs to bring more discipline to this area, and they need to make it clear,” he said.

A key issue is test accuracy, which relies on measurements known as sensitivity and specificity. A very sensitive test captures all true positive results. A very specific test identifies all true negative results.

In April, researchers led by Dr. Alexander Marson, an immunologist at the University of California, San Francisco, analyzed 14 COVID-19 serologic tests on the market and all but one gave false-positive results. I found that. Coronavirus when they didn’t actually. In this study, the false positive rate reached 16%, which has not yet been peer reviewed.

The unreliable results worry Dr. Jeff Duchin, a public health officer in Seattle, Washington and King County, where the first surge of COVID-19 cases occurred in the United States. A person who tests positive for absent antibodies is free to he or she to ignore guidance on the prevention of infection and the potential for spread of the disease. “Whether positive or negative, the workplace still needs to take action,” he said. “They should never think that a test program is free from its responsibilities.”

FDA officials said they are now working independently with the National Cancer Institute to independently validate serologic tests in the market. Until that list is published, users have to rely on a relatively small number of users who have ever been authorized for emergency use. Pending FDA review, over 190 people are seeking approval.

However, consumers may have little control because they are likely to have been tested by their employers and doctors and have little understanding of why those products were chosen.

“There are no national standards, no one-stop-shop for antibody tests or consumer reports,” Becker said. “I don’t think the general public can understand this.”

Even experienced doctors can have problems. A physician-owned medical services group, US Acute Care Solutions is testing a Chinese-made test provided by Minneapolis-based Premier Biotech, and has staffed more than 3,500 physicians and employees. The group’s chief medical officer said it will be tested, Dr. Amel Aldeen. The test is widely used, including the recent controversial serological survey conducted by Stanford University and the University of Southern California.

When USACS used it, the Premier test was sick and failed to detect antibodies in some employees who were positive for coronavirus in the diagnostic test, Aldine said. The results may have been caused by incorrect instructions rather than flaws in the test itself, he said. Still, the Premier Test was not FDA-approved and as a result he was suspended.

“It’s bad to choose a test that hasn’t been approved by the FDA,” he said.

In a statement, Premier Biotech officials expect to exceed FDA standards and therefore require at least 90% accuracy in identifying positive antibodies in samples and 95% accuracy in identifying non-antibody samples I said.

(Editor: The story can end here)

Some people may ask why the FDA did not identify some reliable antibody tests and require their use to avoid confusion. An FDA official said that making such a choice would be outside the responsibilities of the authorities.

“The FDA lane is to review these tests and make sure they are safe and accurate for Americans,” said Emma Spaulding, a spokesperson. “It’s not in our lane to say which test should be used.”

Health officials understand the need for a test that can provide comfort in the uncertainty of COVID-19, but Ducin advised employers and consumers to wait a little longer.

“It’s costly to test with unverified tests that may outweigh the benefits of meeting your curiosity,” he said.

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(Kaiser Health News (KHN) is a national health policy news service. An editorial independent program of the Henry J. Kaiser Family Foundation.)

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©2020 Kaiser Health News

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