& Co. is investigating reports from nursing homes that federally provided rapid coronavirus testing equipment from the company is producing false-positive results in some cases.
So far, the number of reports is small, nursing-home industry officials said. The American Health Care Association, a trade group representing nursing homes, said it has heard from roughly a dozen facilities that had seen a significant number of false positives and a similar number with just one or two.
False-positive test results are a particularly significant risk in nursing homes, because a resident wrongly believed to have Covid-19 could be placed in an area dedicated to infected patients, potentially exposing an uninfected person to the coronavirus.
“It’s enough to warrant taking it seriously,” said David Gifford, chief medical officer of AHCA. It’s not clear if the false positives are more frequent than expected, he said. The group alerted its members about the concern with Becton Dickinson machines on Monday.
Katie Smith Sloan, chief executive of LeadingAge, which represents nonprofit providers of aging services, said, “Reports of false positives are troubling and add to the many challenges nursing homes have to navigate.”
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The Department of Health and Human Services announced in July that it would ship
and Becton Dickinson rapid-testing machines and a limited supply of test kits to approximately 14,000 nursing homes nationwide. Quidel machines have gone to fewer facilities, and the company said it had not received any reports of false-positive results from nursing homes that got its testing equipment from HHS.
The concern about false positives is the latest challenge surrounding the federal effort to broaden testing in nursing homes, as they and other long-term care centers are tied to more than 70,000 Covid-19-related deaths nationwide, according to a Wall Street Journal survey of state and federal data. The push relates to a new regulatory mandate from the Centers for Medicare and Medicaid Services requiring regular testing of nursing-home staffers.
Nursing homes have said they are struggling to get refill tests for the federally supplied rapid-testing machines that they received, and they are also worried about costs and, in some places, conflicting guidance from state regulators.
A spokesman for Becton Dickinson said in a statement that “a small number of nursing homes in the U.S. are reporting multiple false positive results” from its Veritor testing equipment. The company said it immediately contacted the sites and is investigating the situation to obtain additional details. The reports don’t reflect findings in the company’s studies, the spokesman said. The company has filled its initial federal order, and now can restock distributors with test kits.
HHS was recently made aware of the issue with false positives and is closely monitoring the situation, an agency spokeswoman said in a statement. The Food and Drug Administration is also looking into the issue, she said. HHS is working to ensure nursing homes have priority for test kits, and has taken several actions to provide “extreme clarity and no room for misunderstanding or misinterpretation” on the role of the tests, she said.
At Presbyterian Village North, in Dallas, eight asymptomatic nursing-home residents and three workers, also without symptoms, tested positive for Covid-19 on a Becton Dickinson machine in the first week of September, said Tim Mallad, chief executive of Forefront Living, the nonprofit that owns Presbyterian Village. The residents were moved into a unit for Covid-positive people.
But the results seemed odd, partly because the residents were from different locations within the facility, and the nursing home retested using a more precise lab-based molecular assay, Mr. Mallad said. All 11 results were then negative, and the residents were moved out of the Covid unit with no signs that they had become infected. For now, Mr. Mallad said, the nursing home will stop using the Becton Dickinson machine for required screening tests, and rely on more-expensive lab-based tests.
“We need more assurances on these before we use them again,” he said.
The Evangelical Lutheran Good Samaritan Society said it has gotten reports of false-positive results from Becton Dickinson equipment in three of its nursing homes, including one that had nine—six staff and three residents. None had symptoms, said officials from the nonprofit, which is part of Sanford Health. “We’re very concerned,” said Nathan Schema, vice president of operations. “We’re struggling with the accuracy of these machines.”
CMS said in a statement that it would use its “enforcement discretion to ensure nursing homes are not penalized for making reasonable efforts to comply with the testing requirements.”
“Any project of this magnitude is bound to encounter challenges,” the agency said.
The Becton Dickinson equipment is used to perform point-of-care antigen tests that don’t have to be sent to labs for processing. Antigen tests focus on virus proteins, while molecular tests look for the virus’s genetic material.
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Appeared in the September 15, 2020, print edition as ‘Testing Maker Probes False-Positive Results.’