Hype collides with science as FDA tries to rein in ‘wild west’ of COVID-19 blood tests – Lebanon Democrat
Posted: June 7, 2020 at 8:45 pm
Save your business while saving lives, reads the website of Because Health, 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.
The Workplace Health 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 and, possibly, future protection.
Theres a tremendous consumer demand, said Dr. Lars Boman, the Boston-based medical director for the firm. Can they return to work? Can they return 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 workplace staffing.
This is a personal choice of the business, of the consumer, Boman said.
Across America, untold numbers of employers, employees and ordinary citizens are turning to a slew of sometimes pricey new COVID-19 blood tests. Knowing whos 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 and the usefulness of the results they provide have prompted the federal Food and Drug Administration to try to rein in what several infectious disease experts described as the wild, wild West of antibody testing.
It does look as if companies sprang up overnight both importing these tests and distributing them, said Dr. Michael Busch, director of the nonprofit Vitalant Research Institute in San Francisco. Its outrageous that people were trying to make money off of this fear.
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 bodys immune response to an invading virus. These are different from the molecular tests, typically done with nasal swabs, used to diagnose infection.
As of June 1, only 15 antibody tests had received FDA emergency-use authorizations, which allow tests that havent been fully vetted to be used in a crisis. Even that standard has become a selling point for some large companies, such as LabCorp and Quest Diagnostics, which emphasize that they rely on tests that have received the FDA nod.
In late May, the FDA removed more than 30 serology tests from a list of commercially available kits, saying they should not be distributed for sale. Removal could result from a manufacturer not submitting an emergency-use authorization request within a reasonable period of time, or if the test shows significant problems that cannot be or have not been addressed in a timely manner, the agency said. The manner of enforcement remains unclear.
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 could be wrong half of the time.
Serologic 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, the guidelines state. Serologic test results should not be used to make decisions about returning persons to the workplace.
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 cant yet answer the crucial question about whether antibodies confer immunity from future COVID-19 infections, Hayden said.
The best possible scenario is that people get infected and they have protective immunity for a long time, she said. That would be awesome. But we just dont have that right now.
But a plethora of tests being pitched to consumers explicitly promise results aimed at allowing a return to work, school and other social arenas.
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.
Anders Boman, the son of the medical director and co-founder of Because Health, said that until the COVID-19 crisis occurred, the company, which launched in Seattle last year, was focused on a niche of integrative care and sexual health, including hormone treatments for men and women.
Consumers are not concerned about sexual health right now, Boman said, explaining the change in focus. Theyre concerned about how to get back to work, how to return to normal and are they safe?
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.
They sort of relaxed all regulatory oversight, Hayden said.
Several experts interviewed by Kaiser Health News said the FDA faced tremendous political pressure to make antibody tests available.
It was really a single pressure 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, said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
The relaxed rules drew concern from Congress, where a subcommittee of the Committee on Oversight and Reform detailed the FDAs failure to police the test market. Groups such as the Association of Public Health Laboratories also raised questions. Scott Becker, the APHLs chief executive, said he spoke to top officials at the U.S. Department of Health and Human Services in early April.
We just let loose and we said, This is a really bad policy, Becker said. Were going to get flooded and were going to lose control of quality. Were not going to know what to do with the results.
Thats exactly what has happened, said Osterholm. The FDA needs to bring much more discipline to this area and they need to articulate it clearly, he said.
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.
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.
Unreliable results worry Dr. Jeff Duchin, the public health officer for Seattle and King County, Washington, where the first surge of COVID-19 cases emerged in the U.S. A person who tests positive for antibodies that dont exist may mistakenly believe he or she is free to ignore guidance about preventing infection, potentially spreading the disease. Regardless of whether you test positive or negative, the workplace still needs to take steps, he said. They shouldnt think a testing program in any way relieves them of that responsibility.
FDA officials said theyre working now with the National Cancer Institute 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.
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.
There isnt a national standard, there isnt a one-stop shop or a Consumer Reports for antibody tests, Becker said. I dont expect a member of the public is going to be able to figure this out.
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 groups chief medical officer, Dr. Amer Aldeen. That test has been widely used, including in recent controversial serology surveys conducted by Stanford University and the University of Southern California.
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.
It does no good to select a test that isnt FDA-approved, he said.
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.
Some might ask why the FDA didnt 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 agencys responsibilities.
FDAs lane is to review these tests and make sure that they are safe and accurate for the American people, said spokesperson Emma Spaulding. It wouldnt be within our lane to say which test must be used.
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.
There are costs to testing with unvalidated tests that might outweigh the benefits of satisfying your curiosity, he said.
Read the original:
Hype collides with science as FDA tries to rein in 'wild west' of COVID-19 blood tests - Lebanon Democrat
- What Is a Hormone Doctor? | eHow [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Learn About Hormone Replacement Therapy [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Bioidentical Hormone Doctors, Thyroid Disorders, Lyme ... [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- Natural Bioidentical Hormone Replacement Therapy (HRT ... [Last Updated On: May 4th, 2015] [Originally Added On: May 4th, 2015]
- What Is a Hormone Doctor? | eHow StemCell Doctors [Last Updated On: June 4th, 2015] [Originally Added On: June 4th, 2015]
- Hormone Replacement Therapy in NYC | NYC Hormone ... [Last Updated On: June 24th, 2015] [Originally Added On: June 24th, 2015]
- Endocrinology - Wikipedia, the free encyclopedia [Last Updated On: September 21st, 2015] [Originally Added On: September 21st, 2015]
- AAG Health - Hormone Replacement Therapy | HGH & Testosterone [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Denver Bioidentical Hormone Therapy Clinic - Biovive Medicine [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Naturopathic Doctor Phoenix | Weight Loss Clinic ... [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- What is an Endocrinologist? What does an Endocrinologist ... [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- HRT | Hormone Replacement Therapy | Testosterone [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Endocrine disease - Wikipedia, the free encyclopedia [Last Updated On: September 29th, 2015] [Originally Added On: September 29th, 2015]
- Hormone Replacement Therapy - Ideal Physician Weight Loss [Last Updated On: October 21st, 2015] [Originally Added On: October 21st, 2015]
- Hormone Replacement | Fred Bloem, MD Holistic Physician ... [Last Updated On: October 24th, 2015] [Originally Added On: October 24th, 2015]
- How to Find a Bioidentical Hormone Doctor [Last Updated On: November 1st, 2015] [Originally Added On: November 1st, 2015]
- Neal Rouzier, MD The Hormone Doctor [Last Updated On: January 27th, 2016] [Originally Added On: January 27th, 2016]
- Hypothyroidism Diagnosis, Symptoms, and Treatment [Last Updated On: February 2nd, 2016] [Originally Added On: February 2nd, 2016]
- A Natural Progesterone Cream by Resonance Direct [Last Updated On: March 1st, 2016] [Originally Added On: March 1st, 2016]
- Network Of Doctors - Renew Man [Last Updated On: March 21st, 2016] [Originally Added On: March 21st, 2016]
- Dr. Komer, MD - Your Temporary Index [Last Updated On: March 25th, 2016] [Originally Added On: March 25th, 2016]
- Dr. Komer The Komer Clinics - Treatment, Education ... [Last Updated On: March 28th, 2016] [Originally Added On: March 28th, 2016]
- Atlantic Age Management - New Jersey Hormone Doctor ... [Last Updated On: April 3rd, 2016] [Originally Added On: April 3rd, 2016]
- Growth Hormone Treatment [Last Updated On: April 8th, 2016] [Originally Added On: April 8th, 2016]
- Information on Thyroid Disorders | Hormone Health Network [Last Updated On: May 11th, 2016] [Originally Added On: May 11th, 2016]
- Transgender hormone therapy Clinic [Last Updated On: June 8th, 2016] [Originally Added On: June 8th, 2016]
- DIM for Hormone Balance - Healthy by Nature [Last Updated On: June 30th, 2016] [Originally Added On: June 30th, 2016]
- MedHelp - Health community, health information, medical ... [Last Updated On: July 2nd, 2016] [Originally Added On: July 2nd, 2016]
- Hormone Replacement Therapy - WebMD [Last Updated On: July 23rd, 2016] [Originally Added On: July 23rd, 2016]
- Hormone Replacement Therapy Boca Raton - Hormone Doctor ... [Last Updated On: July 23rd, 2016] [Originally Added On: July 23rd, 2016]
- How to Balance Hormones Naturally | Wellness Mama [Last Updated On: July 24th, 2016] [Originally Added On: July 24th, 2016]
- Integrative Medicine Denver | Hormone Replacement Therapy [Last Updated On: August 28th, 2016] [Originally Added On: August 28th, 2016]
- HGH.com - Natural Human Growth Hormone Supplements [Last Updated On: September 5th, 2016] [Originally Added On: September 5th, 2016]
- The Physician Assistant Life - Essay [Last Updated On: September 24th, 2016] [Originally Added On: September 24th, 2016]
- Man vs. Estrogen: It's Not Just A Woman Thing! | Seasons ... [Last Updated On: September 28th, 2016] [Originally Added On: September 28th, 2016]
- Bioidentical Hormones: Dr. John R. Lee's Three Rules for BHRT [Last Updated On: October 5th, 2016] [Originally Added On: October 5th, 2016]
- Endocrinology - Wikipedia [Last Updated On: October 25th, 2016] [Originally Added On: October 25th, 2016]
- TODAY Video - Latest TODAY show clips, news & video ... [Last Updated On: November 11th, 2016] [Originally Added On: November 11th, 2016]
- Hormonal Imbalance Anxiety a Precursor to Other Health ... [Last Updated On: December 7th, 2016] [Originally Added On: December 7th, 2016]
- DIM for Hormone Balance - blog.healthybynaturehwc.com [Last Updated On: December 7th, 2016] [Originally Added On: December 7th, 2016]
- Medicine - Wikipedia [Last Updated On: January 8th, 2017] [Originally Added On: January 8th, 2017]
- Steroid - Wikipedia [Last Updated On: January 8th, 2017] [Originally Added On: January 8th, 2017]
- Thyroid Disease Manager : Diagnosis and Treatment of Graves [Last Updated On: January 13th, 2017] [Originally Added On: January 13th, 2017]
- Dr. Brian Irwin: BPH is a common but uncomfortable disorder - Conway Daily Sun [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- Hospital adds doctors at Dove's Landing - Oroville Mercury Register [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- Veracyte (VCYT) Enters Agreement with Quest Diagnostics (DGX) to Expand Patient Access to GEC - StreetInsider.com [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- Dear Dr. Roach: Elevated calcium level may signal excess hormone - Herald & Review [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- Endocrine disease - Wikipedia [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- What causes infertility and how can it be treated? - WRDW-TV [Last Updated On: February 8th, 2017] [Originally Added On: February 8th, 2017]
- Doctor's Tip: What is the safest cookware? - Glenwood Springs Post Independent [Last Updated On: February 10th, 2017] [Originally Added On: February 10th, 2017]
- Nonbinary students confront surgery challenges - Yale Daily News (blog) [Last Updated On: February 10th, 2017] [Originally Added On: February 10th, 2017]
- Human Growth Hormone - Rejuvalife Vitality Institute [Last Updated On: February 10th, 2017] [Originally Added On: February 10th, 2017]
- Shed pounds to lower the risk - Times of India [Last Updated On: February 11th, 2017] [Originally Added On: February 11th, 2017]
- Colorado House panel rejects three GOP abortion bills - The Denver Post [Last Updated On: February 11th, 2017] [Originally Added On: February 11th, 2017]
- Dems defeat anti-choice bills - Pueblo Chieftain [Last Updated On: February 11th, 2017] [Originally Added On: February 11th, 2017]
- People get test results, have more tests done at Live Healthy 2017 Health Fair - Grand Island Independent [Last Updated On: February 12th, 2017] [Originally Added On: February 12th, 2017]
- Physicians' Education Resource Plans Most Impactful Miami ... - PR Web (press release) [Last Updated On: February 13th, 2017] [Originally Added On: February 13th, 2017]
- Windsor doctor penalized for 'reckless' narcotics prescribing - Windsor Star [Last Updated On: February 13th, 2017] [Originally Added On: February 13th, 2017]
- 'Bathroom Bill' is discrimination - Emporia Gazette [Last Updated On: February 13th, 2017] [Originally Added On: February 13th, 2017]
- What's in store: Chronos - bestofneworleans.com [Last Updated On: February 13th, 2017] [Originally Added On: February 13th, 2017]
- A lot of blood, for no reason? Common, costly clot test has few benefits - Knowridge Science Report [Last Updated On: February 15th, 2017] [Originally Added On: February 15th, 2017]
- Ask the Doctor: Dizziness, Graves' disease, herbal remedies - WNDU-TV [Last Updated On: February 15th, 2017] [Originally Added On: February 15th, 2017]
- The Thyroid Problem: How you can identify thyroid issues and free your health - Black Hills Pioneer [Last Updated On: February 15th, 2017] [Originally Added On: February 15th, 2017]
- 5 Reasons Real Women Chart Their Menstrual Cycle - Verily [Last Updated On: February 15th, 2017] [Originally Added On: February 15th, 2017]
- Holistic Medicine Doctor in Dever, Colorado | BioViveMD [Last Updated On: February 15th, 2017] [Originally Added On: February 15th, 2017]
- With health care repeal looming, women turn to IUDs and other long-term birth control - Kansas City Star [Last Updated On: February 17th, 2017] [Originally Added On: February 17th, 2017]
- Older women reduce their endometrial cancer risk with weight loss - Fox News [Last Updated On: February 17th, 2017] [Originally Added On: February 17th, 2017]
- Chief justice cheers turnout at Longview off-site session - Longview News-Journal [Last Updated On: February 18th, 2017] [Originally Added On: February 18th, 2017]
- What's It Like Getting Health Care As A Black Transgender Person? - BuzzFeed News [Last Updated On: February 19th, 2017] [Originally Added On: February 19th, 2017]
- The Secret Behind Trump's Flowing Locks - eParisExtra.com (blog) [Last Updated On: February 20th, 2017] [Originally Added On: February 20th, 2017]
- Family pushes bill expanding medical training in schools - WBIR.com [Last Updated On: February 20th, 2017] [Originally Added On: February 20th, 2017]
- Quick fix: Zeman turns last-place Pescara around in 3 days - The Republic [Last Updated On: February 20th, 2017] [Originally Added On: February 20th, 2017]
- Major study finds testosterone therapy is no fountain of youth - Philly.com [Last Updated On: February 21st, 2017] [Originally Added On: February 21st, 2017]
- Perth doctor Amish Dwarka Singh guilty over weight loss, bodybuilding prescriptions - ABC Online [Last Updated On: February 23rd, 2017] [Originally Added On: February 23rd, 2017]
- Introducing Bio-Identical Hormone Replacement Therapy at Young Medical Spa in Center Valley and Lansdale ... - PR Web (press release) [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]
- Is testosterone-replacement therapy good or bad? One man suffering from low levels searches for answers. - Men's Fitness [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]
- Area doctor to launch book on women's health during menopause - Southgate News Herald [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]
- Obesity May Raise Girls' Risk of Asthma, Allergies - WebMD [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]
- Doc: Pill's hormone regulation benefits women with PCOS - The Detroit News [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]
- USMLE Step 1: Postpartum amenorrhea and hormone levels - American Medical Association (blog) [Last Updated On: March 6th, 2017] [Originally Added On: March 6th, 2017]