tests

Some states raising doubts about federal tests sent to nursing homes

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.



a plastic bag: A medical center worker holds an antibody tests kit in White Plains, N.Y., April 29, 2020.


© View Press/Corbis via Getty Images, FILE
A medical center worker holds an antibody tests kit in White Plains, N.Y., April 29, 2020.

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

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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 Lifts Block on Rapid Covid-19 Tests in Nursing Homes

The state of Nevada withdrew a directive that blocked nursing homes from using federally provided rapid coronavirus testing equipment late on Friday, in response to an order from the Trump administration.

Nevada told nursing homes on Oct. 2 to stop using the rapid-testing equipment, citing concerns about false-positive results. The back and forth highlights a debate over the proper use of the tests after reports of some false positives.

In a letter to state officials, Adm. Brett Giroir, the Department of Health and Human Services official who has overseen U.S. testing efforts, said the state’s action to ban use of the tests was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” The letter was dated Oct. 8 and made public Friday.

Adm. Giroir defended the performance of the federally supplied equipment on a call Friday with reporters, saying the false-positive rate was low and the issue could be managed by using proper procedures to confirm results. The state’s action wasn’t justified, he said. Adm. Giroir declined to say what enforcement action the federal government could take against Nevada, but said he expected the state to comply with the federal order.

“We are very disappointed by the letter received today from U.S. HHS Giroir, as our goal remains united in protecting those most vulnerable in our communities,” Ihsan Azzam, Nevada’s chief medical officer, said. “We too want more testing with rapid turnaround in Nevada, but the results of those tests must be accurate as they affect clinical care.”

“We are not saying the tests have no use, we are just saying pause for further review and additional training,” he added. The health department issued a new bulletin late on Friday, recommending that nursing facilities continue to perform

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HHS Testing Czar Rips Nevada for Stopping Rapid Tests in Nursing Homes

WASHINGTON — Nevada public health officials’ recent actions preventing nursing homes from using rapid screening tests for COVID-19 are “unjustified” and don’t follow the science on testing, Department of Health and Human Services (HHS) “testing czar” Adm. Brett Giroir, MD, said Friday.

The state’s actions are “not scientifically valid. They must cease their prohibition immediately,” Giroir said on a phone call with reporters. “If you need technical support,” he told the nursing homes, “we are enthusiastic to do more. Lives are at stake and our administration is not going to allow action to risk our seniors or any other vulnerable or underserved population.”

Letter Sent to Nursing Homes

On October 2, the Nevada Department of Health and Human Services sent a letter to healthcare providers and long-term care facilities, noting that the Centers for Medicare & Medicaid Services had sent point-of-care antigen tests to nursing homes across the country — specifically, the Quidel Sofia test and Becton Dickinson’s Veritor test. The letter noted that according to the FDA’s emergency use authorization data, Quidel claimed 87% sensitivity and 100% specificity for its test, while Becton Dickinson’s numbers were 97.5% and 100%, respectively.

“However, this was based on extremely limited data,” wrote Ihsan Azzam, MD, PhD, the state’s chief medical officer, and two colleagues. The state conducted its own test after it “started receiving anecdotal reports from SNFs [skilled nursing facilities] that individuals with a positive antigen test were subsequently testing negative” with polymerase chain reaction (PCR) assays, generally considered the most accurate. The state looked at data from 12 nursing homes that conducted 3,725 rapid tests, of which 60 came back positive. Of those, 39 were sent for PCR testing; 16 (40%) came back as true positives while 23 (60%) were false positives.

“Possible reasons for conflicting test results include lack

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Trump Administration Orders Nevada to Allow Rapid Covid-19 Tests in Nursing Homes

The Trump administration ordered the state of Nevada to withdraw a directive blocking nursing homes from using federally provided rapid coronavirus testing equipment, highlighting a debate over the proper use of the tests after reports of some false-positive results.

In a letter to Nevada officials, Adm. Brett Giroir, the Department of Health and Human Services official who has overseen U.S. testing efforts, said the state’s action is “inconsistent with and pre-empted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” The letter was dated Oct. 8 and made public Friday.

Adm. Giroir defended the performance of the federally supplied equipment on a call Friday with reporters, saying the false-positive rate was low and the issue could be managed by using proper procedures to confirm results. The state’s action wasn’t justified, he said. Adm. Giroir declined to say what enforcement action the federal government could take against Nevada, but said he expected the state to comply with the federal order.

Nearly 100 people died during the height of the coronavirus outbreak at the Menlo Park Veterans Memorial Home in April, more than 10 times the number in a typical month. Among those who died were 84-year-old Isabella Kovacs and 86-year-old Joan Williams. Their stories provide a window into what went wrong at the New Jersey facility. Photo: Shari Davis/Julie Diaz

The Nevada Department of Health and Human Services didn’t immediately respond to a request for comment. Nevada told nursing homes on Oct. 2 to stop using the rapid-testing equipment, citing concerns about false-positive results.

The federal government has been supplying equipment from

Quidel Corp.

and

Becton Dickinson

& Co. to about 14,000 nursing homes around the country, which can use the machines to fulfill a federal mandate to test staffers. They perform

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