Citing

Some states raising doubts about federal tests sent to nursing homes, citing shaky reliability

Several states have curtailed using coronavirus testing equipment in nursing homes that was provided by the Trump Administration after concerns were raised about the results, including false positives that risk mistakenly sending vulnerable seniors into special COVID isolation wings that could ultimately expose them to the virus.

Since July, the administration had been rushing out the machines from manufacturers Becton, Dickinson and Company and Quidel to more than 14,000 facilities around the country in an attempt to identify outbreaks faster and stem the tide of the virus, which has taken a particular toll on the elderly, especially those in nursing homes and other assisted living facilities.

“We have a real crisis around testing,” said Dr. Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “We don’t have the capacity to supply every facility with … the more reliable and accurate tests and the tests we do have are not accurate and unreliable.”

The machines process cheaper-to-produce kits known as antigen tests — which can yield results in 15 minutes. While other diagnostic tests for COVID-19 like PCR tests look for genetic material from the virus, antigen tests look for molecules on the surface of the virus, diagnosing an active coronavirus infection faster than molecular tests.

Although they are not perfect, many experts view these tests as an important component in the effort to fight COVID-19. The rapid turnaround time means they can be used in bulk to screen dozens of people in quick succession, with any potentially positive cases later confirmed with a more accurate PCR test. These are the tests, for instance, that the White House requires everyone to take before they enter the complex.

MORE: Faster, cheaper COVID-19 tests in danger of creating blindspot in data collection

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Nevada halts use of rapid coronavirus tests in nursing homes, citing inaccuracies.

The coronavirus tests kits are small and fast — they produce results in as a little as 15 minutes — and when they were first distributed to nursing homes around the country in August by the federal government, they were welcomed with open arms.

At last it seemed, there was a solution to the delays and equipment shortages that had stymied efforts to use laboratory-based tests to curb outbreaks.

But now Nevada has ordered its nursing facilities to immediately suspend the use of two of the rapid virus tests after their performance was found to be lacking, according to a directive issued by the state’s department of health.

The order was prompted by a spate of false-positive results, in which the tests mistakenly found that healthy people were infected. The state directed that use of the kits be discontinued “until the accuracy of the tests can be further evaluated,” the Nevada document said.

The rapid tests are manufactured by two companies: Quidel, and Becton, Dickinson and Company, Representatives for the companies defended their products and said they were conducting investigations into the reports of false positives in Nevada.

Lisa Sanders, director of media relations at LeadingAge, an association of nonprofit providers of aging services, said that several nursing homes in other states had been experiencing issues with BD and Quidel’s tests and reporting them to her organization and the American Health Care Association in recent weeks.

In submitting their applications to the Food and Drug Administration for emergency clearance, both BD and Quidel declared that their tests had no false positives.

But shortly after the tests were rolled out across the state this summer, nursing homes began to report that people who had been evaluated by both the rapid tests and a slower but highly reliable laboratory test, called P.C.R.,

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Nevada Halts Use of Rapid Coronavirus Tests in Nursing Homes, Citing Inaccuracies

Kristen Cardillo, BD’s vice president of global communication, said the company was aware of the situation in Nevada and was “conducting thorough investigations.” She added that “based on the information in the directive and the total tests performed, we believe the rate of reported false positives is well within what we would expect for the BD Veritor System.”

Representatives for the Department of Health and Human Services did not respond to requests for comment.

Concerns have also been raised about the ability of antigen tests to accurately pinpoint infections, especially if administered during a period when a person harbors low levels of the coronavirus. BD’s test is advertised as having a false negative rate of 16 percent. Quidel’s is just above 3 percent. The directive from Nevada’s department of health did not report whether the negative antigen test results from nursing homes — there were nearly 3,700 such results — had been confirmed by P.C.R.

In a call with LeadingAge members on Monday, Adm. Brett Giroir, who has been leading the nation’s testing efforts, said antigen tests were “clearly a lifesaving option,” and for many facilities the best test available, given the delays, expenses and shortages that had plagued P.C.R. tests.

“It is perfectly acceptable for congregate care, particularly nursing homes, to use an antigen test, even if they are, quote, off-label,” Dr. Giroir said in the interview. “Just because they don’t have an authorization doesn’t mean they’re not good for it.”

In response to questions about false positives, Dr. Giroir reminded LeadingAge members that in places where the coronavirus is scarce, false positives should be expected to outnumber true positives and do not necessarily invalidate the usefulness of a test. “That’s a function of the way life is,” Dr. Giroir said.

The halt to antigen testing in Nevada’s nursing

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