Giroir: With PCR Tests Out of Reach For Most Nursing Homes, Antigen Testing ‘Is Clearly a Life-Saving Option’

The nation’s top COVID-19 testing official gave more insight into the Department of Health and Human Services’ (HHS) efforts to expedite and expand the use of rapid point-of-care antigen testing in skilled nursing facilities across the U.S. during a media briefing held Tuesday.

HHS announced on Monday that it was expanding coverage for licensed health care professionals to prescribe or administer point-of-care COVID-19 tests under the Public Readiness and Emergency Preparedness Act (PREP Act). In doing so, it overrode any rules imposed by states forbidding the use of antigen tests in the SNF setting.

The guidance from HHS also included information from several regulatory agencies — the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) — addressing the question of whether the rapid point-of-care tests that form the backbone of HHS’ nursing home testing initiative can be used to screen asymptomatic individuals.

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HHS assistant secretary for health Admiral Brett Giroir emphasized in the announcement of the guidance, and in his prepared remarks on Tuesday, that the priority was to expand the use of the antigen tests for screening in congregate settings such as SNFs.

“We’re not going to risk seniors because of paperwork issues, or misunderstanding, so we wanted to take care of that,” he said Tuesday.

Questions about how accurate antigen tests are when screening asymptomatic people have begun to surface as HHS continues to ship testing devices, sourced from the medical device manufacturers Becton Dickinson (BD) and Quidel, out to SNFs across the U.S., with the geographic focus widening from individual counties to entire states.

A Kaiser Health News report noted that the devices did not appear to be intended for such testing.

But long turnaround times have plagued the results for testing initiatives that rely on the polymerase chain reaction (PCR) tests, which identifies the genetic material in the virus itself. Antigen tests, by contrast, detect fragments of proteins on or within the virus by testing samples collected from the nasal cavity.

Giroir asserted that these tests are commonly used for diagnostics across the health care system in his prepared remarks on Tuesday, but he acknowledged that they are not as sensitive for diagnosing infection as the molecular PCR tests, which are laboratory-based.

CMS last week implemented stricter COVID-19 testing requirements for nursing homes, with greater fines for non-compliance. The frequency of required employee testing will depend on the level of infection in a SNF’s surrounding community, the agency said.

These requirements make it all the more crucial that SNFs have access to the point-of-care antigen testing devices, Giroir said Tuesday.

“If you can meet CMS standards with highly sensitive molecular tests using PCR, testing residents and staff as often as twice per week, with a turnaround time of 24 hours or less, and can afford to do that — that’s about $1 billion per month in the industry — it is perfectly appropriate to use molecular PCR tests,” he said. “If you cannot, as most nursing homes cannot, point-of-care antigen testing is clearly a life-saving option and is available in quantities of 10 billion per month or more.”

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