STATEN ISLAND, N.Y. -- The Food and Drug Administration (FDA) revoked Chembio’s emergency use authorization for its coronavirus (COVID-19) antibody test — nearly two months after Borough Hall forged a partnership with the lab manufacturer to test Staten Island’s nursing home staff and residents, along with medical workers at Richmond University Medical Center (RUMC).
Chembio had one of the first antibody tests authorized by the FDA during the coronavirus outbreak, and was targeted by Borough President James Oddo and Dr. Ginny Mantello, the borough’s health and wellness director, to create a fuller picture of the virus’ spread in Staten Island’s nursing home facilities.
Announced in late April, baseline testing of all residents and staff has occurred within one borough nursing home, according to Mantello, with approximately 700 tests conducted in total across three nursing home facilities on Staten Island. Additionally, the Advance/SILive.com reported that hundreds of tests were performed on RUMC staffers by early May as part of the partnership.
Chembio’s emergency use authorization was rescinded after independent testing by the FDA showed “poor device performance observed in multiple evaluations since authorization,” read a letter from Denise Hinton, chief scientist of the FDA, to Chembio.
“FDA has concluded it is not reasonable to believe the product may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of your device outweigh its known and potential risks,” the letter read.
Oddo said he was “frustrated” to hear the news that Chembio lost its ability to conduct the tests, but said, “there’s an inherent risk anytime you go into a collaboration with someone that’s been given an emergency use authorization.”
“We have to own the fact that the FDA has rescinded the emergency use,” Oddo said.
While testing was well underway in multiple nursing homes and within RUMC, Oddo said, “there weren’t really many clinical decisions at all that were made based on the results,” saying that the testing was used to cohort and isolate patients when possible — a practice that was already being conducted following baseline diagnostic testing at Staten Island’s nursing homes.
Ultimately, the harm caused by the revocation of the emergency use authorization is minimal, Oddo said, “other than an entity like RUMC is going to have to say, in order to keep everyone satisfied, ‘we’ll throw those tests out’ and maybe we’ll retest.‘ ”
“The net-impact of it is not appreciable,” Oddo said.
Mantello, who was largely responsible for creating the partnership at a time when widely testing nursing home residents and staff was not yet a reality on Staten Island, said that Borough Hall “took all the information and the resources available to us as best we could, and we applied it as best as we could.”
Commenting on the vast changes in the frequency and availability of testing compared to April — when Chembio was sought for the partnership — Mantello said, “Today, it doesn’t matter because the state and the city have come into the nursing homes and done testing for all the staff and all the residents, so it doesn’t apply as much today, it’s not as relevant to have the antibody (test) as it was a month or two ago.”
Following an executive order by Gov. Andrew Cuomo requiring nursing homes to test staff twice a week — an obligation that Borough President James Oddo said was “nearly impossible” given the financial and staffing burden it placed on the establishments — the New York City Department of Health and Mental Hygiene (DOHMH) stepped in to cover some of the testing costs and said it would deliver staff to borough nursing homes in an effort to meet the requirements, the Advance/SILive.com previously reported.
The controversial order has also been modified for regions in Phase 2 of New York’s reopening plan, only requiring testing of nursing home staff once a week — a request previously made by Oddo in a letter to Cuomo.
Nearly 30% of the borough’s virus deaths came at nursing home facilities, state Health Department data shows.
According to the independent FDA testing, Chembio’s initial submitted data — which met the agency’s “may be effective” standard for emergency use authorization — fell far short of the test results in practice.
Chembio did not immediately respond for a request to comment.
Independent evaluation conducted by the Department of Health and Human Services and the National Institutes of Health showed a “high false positive rate,” according to data provided by the FDA.
According to the letter, Chembio said an investigation into the test’s poor performance was conducted; however, its results were still short of the FDA’s threshold for an emergency use authorization.
Testing for IgM antibodies, which is usually the first antibody produced by the immune system in response to a virus, the FDA says Chembio’s new test showed a 57.1% estimate of sensitivity — the measure used to assess the ability of a test to correctly identify those with the disease.
The test also had a 78.6% sensitivity rate for IgG antibodies, which develop in most patients a week after infection and could indicate some form of resistance to future infection.
The combined IgM and IgG testing showed 82.1% sensitivity — short of the FDA’s threshold for emergency use authorization.
Those results stood in stark contrast to Chembio’s initial data, which showed a 77.4% sensitivity for IgM antibodies, an 87.1% sensitivity for IgG antibodies and a 93.5% sensitivity for combined IgM and IgG antibodies.
“In short, the information you have provided does not address our concerns about the performance issues observed with you device, and we are unaware of any other currently available information that resolves these concerns,” the FDA’s revocation letter read.
As a result of Chembio’s antibody test being revoked, the FDA said it may not be distributed moving forward.
“Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health in a media release last week.
“By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate – including taking action when a test’s benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public,” Shuren said.