Nevada

Federal Official Threatens Nevada for Halting Rapid Tests in Nursing Homes

The leader of the nation’s coronavirus testing efforts condemned Nevada’s health department on Friday for ordering nursing homes to discontinue two brands of government-issued rapid coronavirus tests that the state had found to be inaccurate.

“Bottom line, the recommendations in the Nevada letter are unjustified and not scientifically valid,” Adm. Brett Giroir, an assistant secretary of Health and Human Services, said in a call with reporters on Friday. The state’s actions, he said, were “unwise, uninformed and unlawful” and could provoke unspecified swift punitive action from the federal government if not reversed.

The rapid tests, which were distributed to nursing homes around the country in August by the federal government, were supposed to address the months of delays and equipment shortages that had stymied laboratory-based tests.

“The important issue is to keep seniors safe,” Admiral Giroir said in an interview on Friday. Antigen tests, he added, were “lifesaving instruments” that had been called “godsends” by some nursing home representatives. About 40 percent of the country’s known Covid-19 deaths came from nursing homes, according to a New York Times analysis.

But Nevada officials had discovered a rash of false positives among two types of rapid tests, manufactured by Quidel and Becton, Dickinson and Company, that had been used in the state’s nursing homes. Both tests look for antigens, or bits of coronavirus proteins, and had been advertised as producing no false positives.

Among a sample of 39 positive test results collected from nursing homes across the state, 23 turned out to be false positives, the state reported. (The bulletin did not specify whether negative results from the antigen tests, of which there were thousands, had been confirmed, leaving the number of false negatives unknown.)

“I would consider that to be a significant number of false positives,” said Omai Garner, a clinical

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Trump health official blasts Nevada after state ends use of rapid coronavirus tests in nursing homes

A top official from the Department of Health and Human Services on Friday urged Nevada to reverse its decision to suspend the use of two rapid coronavirus tests in nursing homes, saying there is no “scientific reason” to justify its action.



Brett Giroir wearing a suit and tie: U.S. Department of Health and Human Services ADM Brett P. Giroir testifies before the House Committee on Energy and Commerce on the Trump Administration's Response to the COVID-19 Pandemic, on Capitol Hill in Washington, DC, June 23, 2020.


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U.S. Department of Health and Human Services ADM Brett P. Giroir testifies before the House Committee on Energy and Commerce on the Trump Administration’s Response to the COVID-19 Pandemic, on Capitol Hill in Washington, DC, June 23, 2020.

Nevada health officials have ordered nursing facilities in the state to immediately suspend the use of two tests, manufactured by companies Quidel and Becton, Dickinson and Co., after the officials said the tests repeatedly delivered false positives.

Nevada officials said 23 out of 39 positive antigen test results from both Quidel and BD were later found by PCR to be negative, according to a directive issued last week. That is an error rate of about 60%, according to the document.

Adm. Brett Giroir, assistant secretary at HHS, said Friday that false positives are a “reality” of the testing ecosystem and are to be expected. Calling the Nevada action “unjustified,” Giroir said the federal agency has sent a letter to the state threatening to take “swift action and appropriate steps” if the decision is not reversed.

This is an “unwise, uninformed and unlawful” decision, Giroir said on a call with reporters. “Nevada’s letter unilaterally prohibiting these tests is in violation of HHS’s PREP Act guidance. Under federal law, Nevada may not prohibit or effectively prohibit such testing.”

He said Nevada’s action “reflects a basic lack of knowledge” about testing and interpreting results.

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Why Nevada halted the use of rapid coronavirus tests in nursing homes

coronavirus

John Minchillo / AP

In this Wednesday, March 11, 2020 photo, a technician prepares COVID-19 coronavirus patient samples for testing at a laboratory in New York’s Long Island.

The state health department has ordered Nevada nursing homes to suspend the use of certain rapid COVID-19 tests because of the likelihood of false positives.

According to an Oct. 2 memo from the state Division of Public and Behavioral Health, the rapid antigen tests are showing that they have a high tendency to produce false positives despite earlier statements from the Food and Drug Administration that if they produced any inaccurate results, they would lead to false negatives.

The FDA added that follow-up testing should be done on negatives, not positives.

However, state public health officials issued guidance to the contrary, which led to data showing 60% of a sample of positives being false.

The wrinkle comes down to the typical application of antigen tests, symptomatic versus asymptomatic test subjects, and unique nursing home protocols.

In a nursing home setting, a test result erroneously showing infection with the pandemic coronavirus is more consequential than a false negative, said Nevada State Public Health Laboratory Director Mark Pandori.

Because there’s a threshold for receiving medical care, a person who received a false negative — meaning they do in fact have the coronavirus — would have to battle the bug at home anyway if symptoms are mild, Pandori said; this presumes sick patients would self-isolate to avoid spreading whatever illness they think they have.

If the symptoms progress enough, those people would still go to the hospital, whether they thought they had COVID-19 or not.

“If you started to have so many bad symptoms that were COVID-related that you needed to be hospitalized, you’d

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Nursing Homes in Nevada Told to Stop Using Rapid Coronavirus Tests

Here’s what you need to know:

Credit…Julia Rendleman for The New York Times

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

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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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