On March 22, Danny came down with a high fever, chills and body aches “like I never experienced before,” and was sick for five days before finally getting better in early April. The importer of marble and stone from Nassau County was pretty sure he’d had COVID-19, even though he hadn’t been tested for the disease.
Once he recovered, he wanted to be certain he could visit his elderly father and play with his young children without fear of passing on the dreaded infection.
By mid-April, Danny became one of the first New York residents to be tested for coronavirus antibodies at Manhattan Cardiology, one of the few clinics offering the screening at the time. Unlike COVID-19 tests, which require the placing of a swab deep inside a person’s nostrils, his serology test simply drew a vial of blood that was sent to a lab for testing.
“I wanted to see if I had built antibodies to the virus,” said Danny, who lives in Sands Point and did not want to be identified by his last name. “I wanted to make sure I wasn’t contagious.”
While antibody tests are being hailed by some as an “immunity passport” — the first step out of the coronavirus pandemic — public-health officials warn that a positive test does not necessarily mean total immunity to the virus.
“There’s an assumption — a reasonable assumption — that when you have an antibody that you are protected against reinfection,” said Dr. Anthony Fauci, an immunologist and member of the White House coronavirus task force, on an April 20 “Good Morning America” appearance. “That has not been proven for this particular virus.”
But for elected officials eager to return to a sense of normalcy and reopen failing economies after weeks of coronavirus lockdown, antibody testing and tracing of COVID-19 on a massive scale have now become de rigueur. Despite the uncertainty and scientists’ lack of knowledge of the virus, hundreds are lining up for the antibody tests in New York, where nearly 300,000 people have tested positive for COVID-19.
“The entire operation has never been done before,” said New York Gov. Cuomo on April 25, pledging to test as many as 40,000 New Yorkers for both the coronavirus and its antibodies on a daily basis.
The military-style operation in the state, which is the epicenter of the virus in the United States, will be conducted with Johns Hopkins University and with funding from former New York City Mayor Michael Bloomberg and the federal government, which has already pledged $1.5 billion to the effort, Cuomo said.
I wanted to make sure I wasn’t contagious.
– Danny of Sands Point, LI, one of the first to get an antibody test at Dr. Robert Segal’s clinic
As of April 27, of those tested in a random sample of 7,500 people, nearly 15 percent were positive, suggesting that statewide more than two million people may have had the virus and shown no symptoms and might now have antibodies to fight against it, Cuomo said. In New York City, early results showed that nearly 25 percent of those tested may have been infected at some point but showed no symptoms.
While the CDC has confirmed that asymptomatic carriers can transmit the disease, it’s still unclear how many of them are contagious and for exactly how long. It’s also unknown whether those who test positive for COVID-19 antibodies are contagious or not.
What the antibody tests do reveal is “what we already know — that the disease is all over the place,” said Marvin Lerner, a retired Manhattan physician and expert on infectious diseases. “Right now we continue to throw money at it with widespread testing, and we think we know what we’re doing. The truth is we’re just wasting billions of dollars.”
Worldwide, there are more than 3 million confirmed cases of COVID-19 and more than 212,000 deaths, according to statistics compiled by Johns Hopkins University. And in the United States, which is now the world leader with more than 1 million confirmed cases, there is still much confusion about the antibody tests themselves, most of which have not been properly vetted by the Food and Drug Administration.
“Doctors should be aware most serology tests haven’t been reviewed by FDA,” tweeted Scott Gottlieb, a physician and former FDA commissioner, on April 21. “Quality is highly variable, with some or perhaps many giving uncertain results. False-positive rates may be inappropriately high. Patients and doctors shouldn’t rely on unproven tests for clinical decisions.”
The head of the world’s largest biotech company took it one step further when he told an April 22 news conference that most of the antibody tests currently on the market are “a disaster.”
“These tests are not worth anything, have very little use,” said Severin Schwan, the CEO for Roche Holding AG, according to Reuters. “Every kind of amateur could produce an antibody test. The two of us could do it overnight in the garage. That’s not the problem. The question is, does it really work?”
Even in the face of these warnings, the FDA is responding to an urgent demand for testing and is now allowing developers to “self-validate” their own antibody tests, clearly labeling their products to indicate they have gone through the vetting on their own and submitted their findings to the FDA.
“It’s kind of like the honor system: The FDA gives you a guideline and you say you followed the guideline and you give them your data,” said Lerner. “But not everyone in business can be trusted and a lot of guys are out there just to make a buck.”
As of April 27, the FDA said it was still reviewing nearly 150 tests and had authorized only seven.
At Northwell Health, which runs 23 hospitals in New York, including Lenox Hill Hospital, staff plan to conduct 10,000 antibody tests per day once their antibody-testing program for the general public gets underway in early May, according to Christopher Zavala, director of business development for Northwell Health Labs. Northwell Health has already started testing hospital workers, a spokesman for the health-care network told The Post.
“Northwell is putting a plan in place for all frontline workers — health-care workers and first responders,” Zavala told The Post. “But because the virus is so new we don’t have any understanding of what will trigger immunity.”
Meanwhile, an increasing number of private clinics in Manhattan are offering serology tests for those who don’t want to wait for public-sector testing.
Cardiologist Robert Segal has been conducting antibody tests at his Manhattan Cardiology clinics on the Upper East Side and Midtown since April 16 “for anyone who has felt that they had exposure to the coronavirus,” he told The Post. He said he’s already tested more than 200 people and is fielding 400 requests a day for the antibody test.
The test itself costs $95, but the price goes up to $299 with pre-screening and administration, Segal said. He is opening up another clinic in Columbus Circle to handle the overflow, he noted. The tests, which are covered by insurance, are set up through LabFinder.com, a platform he co-founded that prescreens candidates before they show up for the blood draw.
“We are not testing the acutely ill,” Segal said. “We are looking for people who feel they may have been exposed to the virus and give them back the trust and confidence that their immune system has developed some kind of level of attack against the virus.”
Segal’s tests have been self-validated and the manufacturer, Diazyme Laboratories, has been authorized by the FDA to produce and market the tests under emergency protocols in place during the coronavirus pandemic, his spokeswoman told The Post.
Unlike some serology test kits that rely on a “pin-prick” sample of blood and feature almost instant results, Segal’s clinics use a vial of blood that is analyzed by a lab. Results take up to 72 hours and are 95 percent accurate, he claimed. “There is a 5 percent false-positive rate which in my world is not dangerous,” Segal said. “Most lab tests have a 5 percent false-positive rate.”
Segal stressed that the tests are not showing full immunity to COVID-19, but the indication of antibodies in the blood that might possibly guard against re-infection and infecting others.
[Antibody protection] has not been proven for this particular virus.
– Dr. Anthony Fauci
Segal and others also hope that those with COVID-19 antibodies will be in a position to donate “convalescent plasma” to help those stricken with the coronavirus fight the disease. The United States has already treated 500 people with convalescent plasma, conducting clinical trials at 1,500 hospitals across the country. Clinical trials are also underway at hospitals around the world to determine whether plasma transfusions could improve a patient’s recovery and help them survive.
Jake Deutsch, a physician and founder of Cure Urgent Care in Manhattan, was also among the first to offer the tests. On April 24, his two clinics on the Upper East and West sides of the city conducted 250 tests and he has 600 others registered on his Web site, he said, adding that he has already started offering walk-in testing at both of his facilities.
“We’ve been very proactive about getting testing because when you are sick and vulnerable you want reassurance,” he said. “I’m a physician in the business of helping people. When the pandemic started we very quickly pivoted when we saw people who wanted to know if they were contagious.”
Less than two days after his antibody test on April 17, Danny got the results that said he had the COVID-19 antibodies in his blood. The test, he claimed, shows he has a 97 percent chance of immunity and is not contagious.
But while the results made Danny feel better, experts are continuing to ask some hard questions not just about their validity, but also about the way they’re carried out.
“Are these tests true?” asked Lerner, who has a Ph.D. in biochemistry from McGill University in Montreal. When he worked as a physician, Lerner often sent back results of even the most mundane kind of medical tests because he didn’t trust the way labs were handling his requests.
“Are the tests being carried out in the right way when you have a system that is basically in chaos and when most of the good lab technicians have been furloughed?” he wondered. “Technology is only dependent on your level of knowledge as a doctor.”
No matter what the experts say, Danny said he feels like his antibody test has given him his life back.
“I feel amazing knowing that I have almost a 100 percent chance of not catching it again,” he said. “I am still very cautious and wearing my mask when I go to the supermarket and the bank, but now I can touch things again. It sounds crazy, but it’s a great feeling.”
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