Here are answers to many questions related to the “safer-at-home” phase of Colorado and Larimer County’s coronavirus response. Wochit
The Colorado Attorney General’s Office issued a cease and desist letter to Functional Medicine Center of Fort Collins for false or misleading marketing of coronavirus antibody tests, reflecting elevated scrutiny of a testing approach currently under review by the U.S. Food and Drug Administration.
Antibody tests, also known as serology tests, analyze a person’s blood for the presence of antibodies that indicate they were previously infected with a disease. For some infections, the presence of antibodies indicates you have some level of immunity to the disease. But it’s still unclear whether that’s the case for coronavirus.
That uncertainty, paired with limited regulatory oversight of the tests, has cast doubt on the idea that they could be used to determine who can safely return to work. Even high-quality tests are likely to yield some inaccurate results, experts say, although some remain hopeful about using the tests as a surveillance tool to track the spread of coronavirus within communities.
Tracking Coronavirus in Colorado: The latest case information, updates
Functional Medicine Center was one of three businesses that received cease and desist letters from Attorney General Phil Weiser between April 21 and 23, all related to false or misleading marketing of coronavirus antibody tests. The other businesses issued letters were Zvia Weight Loss and MedSpa in Lakewood and Red Tail Wellness Centers in Boulder. The letters were made public Friday. The cease and desist orders instruct the business to stop making misleading claims about the tests, not to stop using the tests.
Other entities administering antibody tests in the Fort Collins-Denver area, including Quest Diagnostics and National Jewish Health, were not issued cease and desist letters.
Weiser said Functional Medicine Center “overstated the reliability of the antibody test they sold” and “failed to adequately disclose that the antibody test, which has not been approved by the FDA, may not be reliable.” The center, an alternative medicine facility run by chiropractor and acupuncturist Ben Galyardt, has been administering antibody tests from the lab Vibrant America. Although Vibrant America reports its tests have a high rate of accuracy, the FDA hasn’t authorized the test, and the agency requires marketing of all antibody tests to make a number of disclosures about possible reliability issues.
In a written statement emailed to the Coloradoan, Galyardt called the test he’s been administering “one of the most accurate in the country.”
“The cease and desist was specifically for some of the language used in our advertising and had nothing to do with the validity or the efficacy of the test,” he wrote. “Our social media team misspoke and we have corrected the verbiage required to be used when discussing the test.”
On the heels of the state attorney general’s announcement, the FDA announced on Monday a plan to confirm the validity of over 175 antibody tests already on the market. The FDA had previously allowed commercial manufacturers to sell antibody tests as long as they notified the agency they’d validated their own tests and the test were properly labeled. They were encouraged but not required to apply for an emergency use authorization, which would mean submitting their validation data to the FDA for approval.
But reports circulated that some companies were selling faulty tests likely to give false positives or false negatives to those being tested for coronavirus antibodies. A team of over 50 scientists studied 14 tests and found that only three of them delivered consistently reliable results.
The FDA is now giving commercial manufacturers 10 business days to apply for an EUA and submit validation data to the agency. The deadline is either 10 business days from the date the company notified the FDA they were doing validation testing or from Monday, whichever is later. Federally certified high-complexity labs, including Vibrant America, can continue to sell tests without applying for an EUA, although they’re encouraged to do so.
Weiser’s investigation of the Functional Medicine Center found the center and Galyardt engaged in illegal marketing by:
- Falsely or misleadingly claiming that the antibody tests have been approved by the FDA
- Falsely or misleadingly stating that the results of the antibody tests are conclusive
- Falsely or misleadingly stating that a positive antibody test indicates immunity to coronavirus
- Making false statements concerning the cost to Functional Medical Center of the antibody tests and/or the profit or loss realized by Functional Medical Center of providing such tests
- Failing to make disclosures regarding the limitations of coronavirus antibody tests that are required by the FDA, including that the test has not been reviewed by the FDA, that negative results do not rule out infection, that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection or to inform infection status, and that positive results may be due to past or present infection with other strains of coronavirus, and/or opining without a sufficient basis that consumers should ignore the FDA’s required disclosures.
Galyardt has been posting regular updates to Facebook Live and YouTube in which he speaks about antibody testing. He said in one video that he wasn’t inclined to trust the World Health Organization’s warnings about the significance of coronavirus antibody tests. He said WHO had overstated the danger of the virus and that “it’s really not as scary as the media wants it to play out.”
Colorado Department of Regulatory Agencies records show Galyardt, who calls himself “Doctor Ben” in his videos, was previously disciplined by the state chiropractic board of examiners for referring to himself as a “chiropractic physician” on his website. State law forbids chiropractors from using the title of “Doctor” or the prefix “Dr.” unless it’s accompanied by the word “chiropractor” or the letters “D.C.” The distinction is required because licensed chiropractors can’t practice surgery or obstetrics or prescribe or administer drugs or anesthetics.
How antibody tests work
Antibody tests can measure for a range of antibodies, but the two most common ones are IgG and IgM.
IgM antibodies indicate a new, possibly contagious infection. IgG antibodies are produced later and stick around in the immune system for a longer period of time. Each person’s immune system produces different amounts of antibodies in response to an infection, and some people — such as the severely immunocompromised — don’t produce them at all.
The science community judges the quality of an antibody test largely on its sensitivity and specificity, with the “gold standard” typically sitting at about 95%, said Dr. Bruce Smith, staff physician and Specialty Services Medical Director for the Colorado State University Health Network. He cautioned that the target could be different for coronavirus tests.
For a coronavirus antibody test, sensitivity is the number of people who get a positive test result divided by the number of people who actually have coronavirus antibodies. Low sensitivity means that many people are getting a false negative, which might lead them to mistakenly believe they haven’t been infected. A coronavirus antibody test with 95% sensitivity would give false negatives to 5% of people who actually do have antibodies.
A test’s specificity is the number of people who get a negative test result divided by the number of people who actually don’t have antibodies. Low specificity means that many people are getting a false positive, which might lead them to mistakenly believe they’ve had coronavirus. A coronavirus antibody test with 95% specificity would give false positives to 5% of people who actually don’t have antibodies.
How often a test result is correct also depends on how prevalent antibodies are in a community. Lower prevalence of coronavirus antibodies in a population means positive test results are less likely to be correct. Higher prevalence of coronavirus antibodies means negative test results are less likely to be correct. That means positive antibody tests results are less likely to be correct now than they will be in the future, assuming more people are exposed to the virus over time.
Jacy Marmaduke covers government accountability for the Coloradoan. Follow her on Twitter @jacymarmaduke. Support stories like this one by purchasing a digital subscription to the Coloradoan.
Read or Share this story: https://www.coloradoan.com/story/news/2020/05/05/coronavirus-covid-19-antibody-tests-colorado-businesses-made-false-claims-ag-says/3085520001/