QDEL QuidelOrtho Corporation

By Christopher Weaver, Anna Wilde Mathews and Tom McGinty 

Thousands of Covid-19 rapid-testing devices are sitting idle in nursing homes around the country, even as some of the facilities face delays in getting results from outside labs, according to federal data.

The federal government spent more than $100 million to send rapid-testing equipment to the vast majority of the nation's nursing homes, but some industry executives say they are concerned about the accuracy of the point-of-care tests, the staff time involved in using them, and guidelines in some states that discourage use of the tests.

Nearly 30% of 13,150 facilities that had rapid-testing equipment for at least two weeks hadn't used it to test a single resident or staff member, according to a federal survey of nursing homes. During weeks when regulations from the Centers for Medicare and Medicaid Services required them to do testing due to local outbreaks, hundreds of facilities didn't use the rapid-testing equipment at all, the survey shows.

The equipment, which allows nursing homes to perform tests on the premises and get fast results, is supposed to help ensure that facilities can catch coronavirus infections early, before they spread. Long-term care facilities have been tied to more than 88,000 Covid-19 deaths in the U.S. since the start of the pandemic, according to a Journal tally of recent state, local and federal data.

"They need accurate testing with rapid turnaround that isn't adding an additional burden on nursing-home staff," said Michael L. Barnett, an assistant professor at the Harvard T.H. Chan School of Public Health. The federally-supplied machines "are not providing what they need, and they're voting with their feet."

As Covid-19 cases surge around the country, more people are seeking tests. "There's absolutely waste" in providing nursing homes with testing machines that aren't being used, Dr. Barnett said.

"It's not what we need," said Barbara Klick, chief executive of Sholom Community Alliance, a nonprofit that uses a lab to test around 500 staffers a week at its two nursing homes in St. Paul and St. Louis Park, Minn. Using the rapid-testing equipment sent by the federal government requires too much staff time, largely for documentation and filing results with the government, she said.

Ms. Klick also worries about the risk of false negative and false positive results from the rapid tests: "It's too unreliable."

In addition to the nursing homes that haven't yet used the devices, another 16% reported using them on fewer than 20 residents and workers, according to the survey data, which is released weekly by CMS and currently updated through the week ending Oct. 25.

Almost half, or 48%, of the nursing homes reported they hadn't used their rapid testing equipment in the most recent week included in the data. Among nursing homes that were required under federal rules to test staff at least once a week due to local outbreaks, 41% said they hadn't used it in the most recent week.

Around 4,900 nursing homes that hadn't used the rapid-testing devices in the most recent week said in the survey that instead they were waiting a day or more for test results from labs.

The rapid tests the federal government provided to nursing homes, known as antigen tests, focus on virus proteins, while molecular tests, the type generally done by labs, look for the virus's genetic material. Lab-based molecular assays tend to be more precise than the fast antigen tests.

Because of concerns about possible false negative and false positive results with antigen tests, particularly when used to screen people without symptoms, public-health officials recommend follow-up confirmatory testing under some circumstances.

The Department of Health and Human Services in July announced plans to ship rapid antigen testing machines made by Becton Dickinson & Co. and Quidel Corp. to about 14,000 nursing homes around the country. An HHS spokeswoman said the cost of the effort has been around $116 million.

"This new testing initiative is critical for keeping vulnerable older adults safe," CMS administrator Seema Verma said in a statement at the time. The department later announced it also would send nursing homes a rapid antigen test made by Abbott Laboratories, known as the BinaxNOW COVID-19 Ag Card, a device roughly the size of a credit card.

Brett Giroir, the assistant secretary at the Department of Health and Human Services who oversaw the program, said 99.3% of nursing homes had recently reported being able to test their entire staffs, a key to keeping the virus out of their facilities. He said it was "fine" for facilities to use the point-of-care devices from the government or other methods.

"We are providing options to meet CMS requirements," Dr. Giroir said, referring to the rules from the Medicare agency that require testing.

An HHS spokeswoman said nursing homes had ordered an additional 4.2 million tests from Becton Dickinson, showing they are using the equipment.

Dr. Giroir has previously defended the performance of the rapid antigen tests. The Food and Drug Administration this week warned about the potential for false positive results, noting that they sometimes occur when users don't follow the manufacturers' instructions.

Quidel, Becton Dickinson and Abbott all said their devices perform very well when used correctly. A spokeswoman for Quidel said it offers customers "a multifaceted approach to training," including a lot of support.

Becton Dickinson said in a statement that testing, including rapid antigen tests, plays "an essential role in detecting Covid-19 and helping to disrupt community spread." Most nursing homes that have its machines are getting regular reorders of tests, the company said.

Abbott said it has worked with nursing homes "proactively to ensure they have the resources needed to best deploy BinaxNOW, including conducting webinars and reaching out to facilities individually."

The HHS spokeswoman said it wasn't clear whether nursing homes were including the Abbott tests in their answers to the federal survey, and that some facilities may be using rapid tests to check visitors.

Some states have discouraged use of the rapid antigen tests. Massachusetts, for instance, has said they can't be used to satisfy state testing mandates for nursing homes.

In North Dakota, where Covid-19 cases are rising, an October state guidance urged cautious procedures in using the antigen tests, suggesting that negative results don't rule out Covid-19 and some positives need to be re-tested.

"The state's not accepting them yet as valid tests," said Sandy Gerving, the administrator of Marian Manor Healthcare Center, an independent nonprofit nursing home in Glen Ullin, N.D. Using the device HHS distributed "seemed like a waste of effort," she said.

Marian Manor had an outbreak in September, Ms. Gerving said, as the virus spread widely in the surrounding community. Thirteen patients died of the virus, federal survey data show. Ms. Gerving said the outbreak at the facility was over. She said the facility had had to test the entire staff 23 times as of Tuesday under state and federal guidelines, sending samples to an outside lab.

Meantime, Marian Manor's point-of-care testing device and its supplies are still in their boxes, Ms. Gerving said. "We're waiting to see, do we send it back or whatever," she said.

Officials at North Dakota's health department didn't immediately respond to requests for comment.

--Brianna Abbott contributed to this article.

Write to Christopher Weaver at christopher.weaver@wsj.com, Anna Wilde Mathews at anna.mathews@wsj.com and Tom McGinty at tom.mcginty@wsj.com

(END) Dow Jones Newswires

November 07, 2020 12:31 ET (17:31 GMT)

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