Nursing homes have new COVID-19 tests that are quick and cheap. So why does NJ not allow their use?

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The test kits can be found in nursing homes across the state, intact.

Unlike standard molecular analysis tests used to detect COVID-19, these offer rapid results in minutes rather than days or sometimes weeks when there are important laboratory backups – like this is often the case in New Jersey.

Nursing home operators have said rapid reading tests could be a game-changer in long-term care facilities hit hard 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 about their accuracy – will not allow it.

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

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

“There’s a lot of frustration,” remarked Aronson, a health attorney who represents nursing facilities and a former director of long-term care licensing and certification at the state Department of Health. . “They don’t give nursing homes the discretion to do testing.”

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

And while every nursing home now allows visitation of family members designated as “essential caregivers,” under an executive directive from the Department of Health, he said they are also not allowed to require tests on these people.

Thousands of nursing home residents have died in nursing homes across NJ, many have been infected with the virus from people from outside. The testing issue is the state’s latest faux pas that has struggled to protect nursing home residents.

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

The state has previously been criticized for the toll COVID-19 has inflicted on nursing homes, particularly due to the lack of adequate protective equipment made available to curb the spread of the epidemic. Last week, veterans groups as well as dozens of healthcare workers and relatives of deceased residents gathered outside the state’s Veterans Memorial Home in Menlo Park, demanding an investigation into the reasons for the at 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 files as well as interviews with families, advocates and behind-the-scenes players , revealed that New Jersey had not reacted quickly enough or taken strong and aggressive actions to slow the deadly outburst at the start of the pandemic.

Antigen tests stored in an NJ nursing home.Photo courtesy of Andrew Aronson

The health ministry said it is currently re-evaluating the use of so-called “point-of-care” testing for residents and staff of long-term care facilities and will issue new guidelines where appropriate.

“While we recognize some of the benefits of point-of-care antigen testing, such as speed of execution and ease of access, we have some concerns about their performance,” explained Thomas Kirn, Medical Director. of the Ministry of Public Health and the Environment. Laboratories.

He said the ministry is looking into the issue of increasing false positives and false negatives, and will come up with recommendations to mitigate that.

“Since false positive results could lead to unnecessary isolation of unaffected individuals, which could strain the workforce, and false negative results could lead to exposure of susceptible individuals to those that are infectious, we need to make sure we first approach safety with sound advice, ”he said.

A spokeswoman added that inspectors are offered weekly tests, but are not required to undergo testing 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 allocated to New Jersey nursing homes and their workers, as part of a legislative reform package enacted by Governor Phil Murphy last Wednesday.

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

These are the approaches that the two main tests used to fight the pandemic take to detect a virus that hides well in the early stages of infection, before symptoms appear.

The most reliable test for COVID-19 uses what’s known as the polymerase chain reaction, or PCR, to detect the virus’s nucleic acid. What makes the molecular test so precise is that the PCR acts like a kind of copier, amplifying tiny pieces of genetic material to spot even traces of the virus. It is currently the basis for most coronavirus tests.

“He’s extremely sensitive because he can see far fewer copies of the virus’s nucleic acid,” said Maria Gennaro, professor of medicine at Rutgers New Jersey Medical School.

But although very accurate, the test turnaround time is slow. The delay makes it particularly difficult to isolate staff who are probably the main carriers of the coronavirus in retirement homes. Asymptomatic workers who stay at work waiting for test results can infect others until lab results come back, experts note.

The tests that 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 the antigen tests may not be present in sufficient amounts to be detected in individuals without symptoms. And she said you don’t know how many virus particles it takes to make someone infectious.

And there is the catch.

Antigenic tests are cheap and very quick. But they give a lot of “false negatives,” she says. This means that people who may have the virus present at low levels can be tested negatively 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, like when Ohio Governor Mike DeWine, who had no symptoms, tested positive for COVID-19 with an antigen test earlier this year. Hours later, the Republican governor underwent a PCR test and was found to be free from the coronavirus.

Still, the Trump administration has pushed antigen testing, especially in nursing homes where the virus has proven particularly deadly. The federal government distributed the tests to 14,000 long-term care facilities across the country in an effort to increase routine screening of residents and staff.

Infectious disease experts, however, question the effectiveness of antigen testing in a nursing setting.

Rangarajan Sampath, scientific director 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 laboratory and in people with symptoms.

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

But in places like New Jersey, where the number of coronavirus cases is now relatively low, antigen testing may not be better than a raffle, he suggested.

“Molecular is clearly a better test. There is no question. But the cost is not the same. And the time is not the same, ”he said. “The antigen tests give you an answer in 20 minutes. But the question is whether you can trust the result of an antigen test, when you run the risk of not isolating those who should be isolated.

Aronson said federal health officials at the end of August had helped meet testing requirements nationwide with rapid point-of-care antigen testing, noting other government guidelines that Also suggested for collective care settings, such as nursing homes, care tests may be superior for overall infection control compared to less frequent and very sensitive tests with extended turnaround times. “

Meanwhile, nursing home officials are asking what happened to the state’s pledges to make a new saliva-based PCR test developed at Rutgers University more widely available.

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

Earlier this summer, the state announced it would provide $ 25 million in funding to support 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 that nursing homes are not getting the help they need.

“They didn’t do anything,” he said of the state. “We have no indication.”

Leusner says nursing homes are receiving Rutgers’ saliva tests.

“Some long-term care facilities contract on their own with Rutgers University,” she says. “The state has invested $ 6 million in Rutgers University, which allows it to increase its capacity, which gives Rutgers the opportunity to offer its saliva tests more widely.

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Ted Sherman can be reached at [email protected]. Follow him on twitter @TedShermanSL.

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