{"id":257030,"date":"2020-06-04T00:31:35","date_gmt":"2020-06-04T04:31:35","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=257030"},"modified":"2020-06-04T00:31:35","modified_gmt":"2020-06-04T04:31:35","slug":"hype-collides-with-science-as-fda-tries-to-rein-in-wild-west-of-covid-blood-tests","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2020\/06\/04\/hype-collides-with-science-as-fda-tries-to-rein-in-wild-west-of-covid-blood-tests\/","title":{"rendered":"Hype Collides With Science As FDA Tries To Rein In \u2018Wild West\u2019 of COVID Blood Tests"},"content":{"rendered":"
\"\"<\/a>
Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests.\u00a0 (Pexels photo)<\/figcaption><\/figure>\n

\u201cSave your business while saving lives,\u201d reads the website of Because Health<\/a>, a Seattle tech startup selling two types of tests to employers willing to pay $350 a pop to learn whether their workers have been infected with COVID-19.<\/p>\n

The \u201cWorkplace Health\u201d plan includes not only nasal swab tests to detect infection, but also blood tests aimed at indicating whether workers have developed antibodies to the virus \u2014 and, possibly, future protection.<\/p>\n

\u201cThere\u2019s a tremendous consumer demand,\u201d said Dr. Lars Boman, the Boston-based medical director for the firm. \u201cCan they return to work? Can they return to life?\u201d<\/p>\n

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 workplace staffing.<\/p>\n

\u201cThis is a personal choice of the business, of the consumer,\u201d Boman said.<\/p>\n

Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing who\u2019s already been infected could have important implications for understanding the spread of the disease, scientists say. But serious questions about the accuracy of some of the serology tests \u2014 and the usefulness of the results they provide \u2014 have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as \u201cthe wild, wild West\u201d of antibody testing.<\/p>\n

\u201cIt does look as if companies sprang up overnight both importing these tests and distributing them,\u201d said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. \u201cIt\u2019s outrageous that people were trying to make money off of this fear.\u201d<\/p>\n

More than 200 tests have 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\u2019s immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.<\/p>\n

As of June 1, only 15 antibody tests<\/a> had received FDA \u201cemergency-use authorizations,\u201d which allow tests that haven\u2019t been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp<\/a> and Quest Diagnostics<\/a>, which emphasize that they rely on tests that have received the FDA nod.<\/p>\n

In late May, the FDA removed more than 30 serology tests<\/a> from a list of commercially available kits, saying they \u201cshould not be distributed\u201d for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a \u201creasonable period of time,\u201d or if the test shows \u201csignificant problems\u201d that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.<\/p>\n

Last month, the CDC issued new guidelines<\/a> warning that, given the low prevalence of the virus in the general population, even the most accurate tests could be wrong half of the time.<\/p>\n

\u201cSerologic test results should not be used to make decisions about grouping persons residing in or being admitted to congregate settings, such as schools, dormitories, or correctional facilities,\u201d the guidelines state. \u201cSerologic test results should not be used to make decisions about returning persons to the workplace.\u201d<\/p>\n

Such tests are most useful for understanding the epidemiology of the virus, not for making individual decisions, said Dr. Mary Hayden, director of the division of clinical microbiology at Rush Medical Laboratories in Chicago. Even the best tests can\u2019t yet answer the crucial question about whether antibodies confer immunity from future COVID infections, Hayden said.<\/p>\n

\u201cThe best possible scenario is that people get infected and they have protective immunity for a long time,\u201d she said. \u201cThat would be awesome. But we just don\u2019t have that right now.\u201d<\/p>\n

But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.<\/p>\n

The tests offered by Because Health are among hundreds churned out since March, ranging from those offered by commercial labs and academic research centers to small developers seeking a toehold in the lucrative market spurred by a global pandemic. Because Health is using two antibody tests in tandem, one of which received emergency-use authorization on May 29; the other is still pending.<\/p>\n

Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID crisis occurred, the company, which launched in Seattle last year, was focused on \u201ca niche of integrative care and sexual health,\u201d including hormone treatments for men and women.<\/p>\n

\u201cConsumers are not concerned about sexual health right now,\u201d Boman said, explaining the change in focus. \u201cThey\u2019re concerned about how to get back to work, how to return to normal and are they safe?\u201d<\/p>\n

The FDA normally follows a stringent approval process for tests to detect diseases, often a costly effort that can take months or years. That typically requires independent validation of the accuracy of the tests. But after being criticized for the fumbled rollout of diagnostic tests during the start of a global pandemic, the FDA swung hard in the other direction, waiving its usual requirements and letting firms rush self-validated tests into the market.<\/p>\n

\u201cThey sort of relaxed all regulatory oversight,\u201d Hayden said.<\/p>\n

Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.<\/p>\n

\u201cIt was really a single pressure \u2014 and that was the fact that the original inability to get a [diagnostic] test on the market in the U.S. as the outbreak escalated means they were trying to do basically everything they could to get these out,\u201d said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.<\/p>\n

The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed<\/a> the FDA\u2019s failure to \u201cpolice the test market.\u201d Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHL\u2019s chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.<\/p>\n

\u201cWe just let loose and we said, \u2018This is a really bad policy,\u2019\u201d Becker said. \u201c\u2018We\u2019re going to get flooded and we\u2019re going to lose control of quality. We\u2019re not going to know what to do with the results.\u2019\u201d<\/p>\n

That\u2019s exactly what has happened, said Osterholm. \u201cThe FDA needs to bring much more discipline to this area and they need to articulate it clearly,\u201d he said.<\/p>\n

A key issue is the accuracy of the tests, which rely 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.<\/p>\n

In April, researchers at the University of California-San Francisco, led by immunologist Dr. Alexander Marson, analyzed 14 COVID-19 serology tests on the market and found that all but one turned up false-positive results, indicating that someone had antibodies to the coronavirus when they actually did not. False-positive rates reached as high as 16% in the study, which has not yet been peer-reviewed.<\/p>\n

Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID cases emerged in the U.S. A person who tests positive for antibodies that don\u2019t exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. \u201cRegardless of whether you test positive or negative, the workplace still needs to take steps,\u201d he said. \u201cThey shouldn\u2019t think a testing program in any way relieves them of that responsibility.\u201d<\/p>\n

FDA officials said they\u2019re working now with the National Cancer Institute<\/a> to independently validate serology tests on the market. Until that list is public, users must rely on the relatively few that have received the emergency-use authorizations to date. More than 190 others have asked for that authorization, pending FDA review.<\/p>\n

But consumers may have little control, because they are most likely getting tests from their employers or doctors, with little understanding of why those products were chosen.<\/p>\n

\u201cThere isn\u2019t a national standard, there isn\u2019t a one-stop shop or a Consumer Reports for antibody tests,\u201d Becker said. \u201cI don\u2019t expect a member of the public is going to be able to figure this out.\u201d<\/p>\n

Even savvy physicians can have trouble. US Acute Care Solutions, a physician-owned medical services group, was trying out a Chinese-made test supplied by Minneapolis-based Premier Biotech, with plans to test its staff of more than 3,500 doctors and employees, said the group\u2019s chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University<\/a> and the University of Southern California<\/a>.<\/p>\n

When USACS used it, the Premier test failed to detect antibodies in several employees who had been ill and tested positive for the coronavirus on diagnostic tests, Aldeen said. The results could have been caused by faulty instructions rather than flaws in the test itself, he said. Still, the Premier test has not received FDA authorization and the results gave him pause.<\/p>\n

\u201cIt does no good to select a test that isn\u2019t FDA-approved,\u201d he said.<\/p>\n

In a statement, Premier Biotech officials said they anticipate exceeding FDA standards, which call for tests that are at least 90% accurate in identifying positive antibodies in a sample and 95% accurate in identifying samples that contain no antibody.<\/p>\n

Some might ask why the FDA didn\u2019t just identify several reliable antibody tests and require their use to avoid the chaos. An FDA official said making that type of choice would be outside the scope of the agency\u2019s responsibilities.<\/p>\n

\u201cFDA\u2019s lane is to review these tests and make sure that they are safe and accurate for the American people,\u201d said spokesperson Emma Spaulding. \u201cIt wouldn\u2019t be within our lane to say which test must be used.\u201d<\/p>\n

Although health officials understand the desire for a test that could provide comfort amid the uncertainty of COVID-19, Duchin advised employers and consumers to wait a little longer.<\/p>\n

\u201cThere are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity,\u201d he said.<\/p>\n

Kaiser Health News<\/a>\u00a0is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.<\/i><\/p>\n","protected":false},"excerpt":{"rendered":"

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