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Government | Health Care

HHS demands reversal on state ban on COVID-19 antigen tests

Students from the University of Nevada, Reno School of Medicine at Washoe County Health District’s drive-thru COVID-19 test site at the Reno-Livestock Events Center on Saturday, May 16, 2020. (David Calvert/The Nevada Independent)

The federal Department of Health and Human Services (HHS) said Friday that Nevada’s recent directive to ban antigen testing for COVID-19 at nursing homes was illegal and contrary to the science on the issue.

“The Department of Health and Human Services will, as our letter clearly stipulates, take swift and appropriate steps to protect Nevada’s if the state of Nevada does not immediately reverse its unwise, uninformed and unlawful unilateral prohibition,” said HHS assistant health secretary Adm. Brett Giroir on a call with reporters Friday.

Nevada's Chief Medical Officer Dr. Ihsan Azzam stood by the state's prohibition.

“We are very disappointed by the letter received today from U.S. HHS Dr. Giroir, as our goals remain united in protecting those most vulnerable in our communities from COVID-19,” Azzam said in a release issued Friday evening.

Azzam said that state only wants to pause usage of the tests to ensure their accuracy.

"Regardless, we need to better understand the issue before encouraging mass use of such tools among our most vulnerable citizens," Azzam said. "We are not saying the tests have no use, we are just saying pause for further review and additional training.”  

Giroir said that there are steps that the federal government could take against Nevada, but did not provide any details when asked.

“We want to work with Nevada and every state,” Giroir said, adding that he is hopeful no punitive action would need to be taken.

At issue is a directive issued by the Nevada Department of Health and Human Services last Friday in which it banned the antigen tests made by Quidel Sofia and Becton Dickinson at nursing homes over getting a high number of false positives. The tests give results in 15 minutes and were distributed to nursing homes around the country in August by the federal government, according to The New York Times. But false positives raised concerns about the tests. Both companies, in submitting their tests to the Food and Drug Administration for emergency clearance, stated in their applications that their tests had no false positives, the paper reported.

He disputed that the false positives that prompted Nevada’s action were cause for concern. 

“It's just a matter of understanding that some false positives are inevitable and you need to deal with them the right, correct way,” Giroir said, adding that the Centers for Disease Control have issued guidance on the matter.  

“A false positive should not be a concern,” he continued. “It’s the reality of the test. We need to be careful to track them to make sure that it’s not out of what we would expect for the test and we’ve made sure that all nursing homes now and have been informed of the appropriate way to report them to the [Food and Drug Administration (FDA)] and we are in close contact with the FDA if we see anything out of the ordinary.”

Giroir said that directive has caused “a lot of discussion and confusion” about the tests, which could hold back their use, which constitutes and significant plank in the nation’s testing protocols established by HHS.

The directive risked “lives acutely” Giroir said and it put Nevada nursing homes “in a terrible position” and “we needed to get out in front of this.”

He said the role of these tests are important because they allow for nursing home workers and the occasional patient to get quick results. That allows staff to begin to quarantine while a more accurate test is given and thereby keeping the virus from spreading.

“Screening tests should be ubiquitous, cheap, available for multiple times per week with a turnaround time of 15 minutes,” Giroir said.

This story was updated on October 9, 2020, at 8:36 p.m. to include comments from Nevada's Chief Medical Officer Dr. Ihsan Azzam

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