Nursing homes have new COVID-19 tests that are fast and cheap. So why won’t N.J. allow them to be used? – NJ.com

The test kits sit in nursing homes across the state, untouched.

Unlike the standard molecular analysis tests used to detect COVID-19, these offer rapid results within minutes rather than days or sometimes weeks when there are significant lab backups — as there frequently are in New Jersey.

Nursing home operators said the quick-read tests could be a game-changer in the state’s hard-hit long-term care facilities, which were devastated by the coronavirus, with nearly 7,000 residents now dead.

But administrators say they are unable to use the new tests in their ongoing battle to protect residents because the state — concerned with their accuracy — won’t allow it.

“Nursing homes want to test everyone who enters their buildings. It keeps COVID out of the buildings,” said Andrew Aronson of the newly formed Nursing Home Advocates of New Jersey, a coalition of some of the state’s largest nursing home operators.

While acknowledging the tests are not as reliable those mandated by the state, he argued that the lack of accuracy is offset by the ability to test more frequently and the tests would provide another layer of protection. They would allow real-time screening of visitors and workers, he said, providing another layer of defense to protect a vulnerable population that now accounts for nearly half of all COVID-19 deaths in the state.

“There is a lot of frustration,” remarked Aronson, a healthcare attorney who represents nursing facilities and a former director of Long-Term Care Licensing and Certification in the state Department of Health. “They are not giving nursing homes the discretion to test.”

What makes the situation even more alarming, he said, is that nursing homes are not permitted to test state inspectors entering their facilities, who he said interact directly with residents.

And while every nursing home is now permitting visitation of family members designated as “essential caregivers,” in accordance with a Health Department executive directive, he said they are not permitted to require testing of those individuals either.

Thousands of nursing home residents have died in N.J. nursing homes, many were infected with the virus by people who came in from the outside. The testing issue is the latest misstep by the state that has struggled to protect nursing home residents.

While nursing homes across the country were devastated by the pandemic, with at least 50,000 deaths nationwide, New Jersey has had the highest rate of death per capita, according to federal data.

The state has already come under fire over the toll COVID-19 has taken on nursing homes, especially over the lack of adequate protective gear made available to curb the spread of the outbreak. Last week, veterans groups along with dozens of healthcare workers and relatives of residents who died gathered outside the state’s own Veterans Memorial Home at Menlo Park, demanding an investigation why least 65 residents and one staff member died there.

An investigation into the state’s nursing home crisis by NJ Advance Media for NJ.com earlier this year, based on internal department records as well as interviews with families, advocates and players behind the scenes, found that New Jersey failed to react fast enough or take forceful, aggressive actions to slow the deadly rampage early in the pandemic.

Antigen tests in storage at a N.J. nursing home.Photo courtesy of Andrew Aronson

The Department of Health said it is currently re-evaluating the use of the disputed so-called “point-of-care” tests for residents and staff in long-term care facilities and will release new guidance “as deemed appropriate.”

A spokeswoman added that inspectors are offered weekly testing, but are not required to be tested because they wear the required level of personal protective equipment such as masks and gloves. “Their presence in a facility is limited, as is their interaction with residents,” said Donna Leusner.

More money is being earmarked for New Jersey nursing homes and their workers, under a package of legislative reforms signed into law by Gov. Phil Murphy last Wednesday.

In the meantime, the Health Department is not backing down on its testing protocols.

At issue are the approaches the two major tests used to fight the pandemic take in detecting a virus that hides itself well in the early stages of infection, before symptoms appear.

The most reliable test for COVID-19 utilizes what is known as polymerase chain reaction, or PCR, to detect the nucleic acid of the virus. What makes the molecular test so accurate is that PCR acts as a sort of copy machine, amplifying tiny bits of genetic material to spot even traces of the virus. It is currently the basis for most coronavirus testing.

“It is extremely sensitive because it can see much fewer copies of the nucleic acid of the virus,” explained Maria Gennaro, a professor of medicine at the Rutgers New Jersey Medical School.

But although highly accurate, the turnaround time for the testing is slow. The delay makes it especially difficult to isolate staff who are likely the major carriers of coronavirus into nursing homes. Asymptomatic workers who stay on the job while waiting for test results can infect others until the lab results come back, experts note.

The tests the nursing homes want to use have a different way of looking for the virus. Known as antigen tests, they seek to identify proteins created by the virus.

Gennaro said the tests do not require a lab and can be done anywhere. But the proteins targeted by antigen tests may not be present in sufficient amounts to detect in individuals without symptoms. And she said it is unknown how many viral particles it takes to make someone infectious.

And there’s the rub.

Antigen tests are cheap and very quick. But they give a lot of “false-negatives,” she said. That means people who may have the virus present in low levels may test negative for COVID-19, giving them an unwarranted sense of security as they spread the virus to others around them.

Or they could give false-positive results, as when Ohio Gov. Mike DeWine, who had no symptoms, tested positive for COVID-19 with an antigen test earlier this year. Hours later, the Republican governor got a PCR test and was found to be free of the coronavirus.

Still, the Trump administration has pushed the antigen tests, especially in nursing homes where the virus proved to be especially deadly. The federal government distributed the tests to 14,000 long-term care facilities nationwide with the aim of increasing routine screening of residents and staff.

Infectious disease experts, though, question the efficacy of antigen tests in a nursing home setting.

Rangarajan Sampath, chief scientific officer of the Foundation for Innovative New Diagnostics, a Geneva-based non-profit group, said antigen testing can be critical in places where there is no access to a lab, and among individuals with symptoms.

“It makes a lot of sense when the prevalence of COVID-19 is high, because it will give you enough accuracy that allows you to isolate those who are infectious,” he said.

But in places like New Jersey, where the number of cases of the coronavirus are now relatively low, antigen testing may be no better than a coin toss, he suggested.

“Molecular is clearly a better performing test. There’s no question. But cost is not the same. And the time is not the same,” he said. “Antigen tests give you an answer in 20 minutes. But what it comes to is whether can you rely on the result in an antigen test, when you are taking the chance of not isolating those who should be isolated.”

Aronson said federal health officials in late August allowed nationwide testing requirements to be met through rapid point-of-care antigen tests, noting further guidance from the government that also suggested for congregate care settings, like nursing homes, “repeated use of rapid point-of-care testing may be superior for overall infection control compared to less frequent, highly sensitive tests with prolonged turnaround times.”

Meanwhile, nursing home officials are asking what happened to promises by the state that it would make a new saliva-based PCR test developed at Rutgers University more widely available to them.

Earlier this year, RUCDR Infinite Biologics at Rutgers University received approval for a PCR-based test that uses saliva rather than swabs for specimen collection. The system is less intrusive, allows those being screened for the coronavirus to simply spit in a tube, which is then analyzed at a lab.

Earlier this summer, the state announced it would provide $25 million in funding to support the weekly testing of nursing home staff and said long-term care facilities would have priority access to the new saliva test.

However, Jonathan Dolan, CEO of the Health Care Association of New Jersey, an industry lobby group, complained the nursing homes are not getting the assistance they need.

“They haven’t done anything,” he said of the state. “We have no guidance.”

According to Leusner, nursing homes are receiving the Rutgers saliva tests.

“Some long-term care facilities contract on their own with Rutgers University,” she said. “The state invested $6 million in Rutgers University, allowing it to increase capacity which, in turn, gives Rutgers the opportunity to offer its saliva testing more broadly.”

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Ted Sherman may be reached at tsherman@njadvancemedia.com. Follow him on Twitter @TedShermanSL.

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Nursing homes have new COVID-19 tests that are fast and cheap. So why won’t N.J. allow them to be used? – NJ.com

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