Laboratories, urgent care centers and other medical facilities around Long Island are offering more options for people who want to be tested for coronavirus antibodies even if they are not essential workers.
At the same time, the FDA announced a crackdown Monday on commercial COVID-19 antibody tests amid questions about their accuracy and marketing.
“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” according to a statement by the FDA.
The questionable tests were probably kept out of the New York market because of the state’s strict protocols, said Dr. Dwayne Breining, executive director of Northwell Health Labs.
“New York State has a pretty rigorous and consumer-protective clinical laboratory regulatory process in place,” he said.
Officials, including Gov. Andrew M. Cuomo, have emphasized the importance of testing as a way to get the state opened up in the wake of the COVID-19 pandemic. The focus has been on front line and essential workers, ranging from police officers and nurses to grocery store clerks.
But entire families can get antibody testing at PM Pediatrics, starting this week. And Quest Diagnostics has an option for patients to get the test by using insurance or paying $119 out of pocket — with results in one or two days.
PM Pediatrics said Monday that it has started offering COVID-19 antibody testing at 36 locations nationwide, including Carle Place, Commack, Manhasset, Massapequa Park, Selden and Syosset.
The New Hyde Park-based pediatric urgent care group said an entire household that includes at least one child can get the test. It does not matter if anyone has shown symptoms of the virus.
The group said in order to schedule an appointment, a parent must download the PM Pediatrics Anywhere app and set up a screening.
The COVID-19 antibody test consists of a blood sample, drawn from a vein. An antibody is a marker in the blood that indicates the body’s immune reaction to a specific infection, in this case COVID-19.
Patients with insurance will have the copay waived, the group said. The out-of-pocket cost for those without insurance is $65.
Since starting the Quest testing program on April 27, about 325,000 COVID-19 antibody tests have been performed across the country, according to company officials.
“We are trying to make sure there is broad access to these tests,” said Kim Gorode, a Quest spokeswoman. “There is a lot of interest in it.”
Gorode said the antibody tests used by Quest meet FDA standards.
Under the revised rules for antibody tests, manufacturers will have to provide validation data within 10 business days of submitting the tests for FDA review.
The FDA has reviewed and authorized 12 antibody tests under its emergency protocols. Among those approved are tests by Hauppauge-based Chembio Diagnostics Inc. and the Wadsworth Center, a laboratory of the New York State Department of Health.
More than 250 other tests are under review, an agency spokeswoman said.
Breining said because the virus is so new, it’s still unclear if the presence of antibodies in former COVID-19 patients will provide them immunity against becoming infected again.
“There is a big fear in the health care community that some people who receive a positive antibody test will think they are immune,” Breining said. “They still need to follow precautions for social distancing. They could still pick up the virus and pass it to vulnerable people around them.”
With David Reich-Hale