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Approval process for unregulated COVID-19 blood tests causing confusion

Blood tests for the coronavirus could play a key role in deciding whether Americans can safely return to normal life, but unregulated tests are creating confusion that could lead to a slow path to recovery.

News 12 Staff

Apr 13, 2020, 9:15 PM

Updated 1,530 days ago

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Blood tests for the coronavirus could play a key role in deciding whether Americans can safely return to normal life, but unregulated tests are creating confusion that could lead to a slow path to recovery.
While finger prick tests do not require FDA approval for sale, health officials say they won't use them until they have been validated by independent laboratories. The labs are working to conduct their own control samples to make sure the tests work as promised.
Nassau County had ordered 20,000 antibody tests to be used for county police officers, but they have not been able to be used because no lab, one of which is Nassau University Medical Center, has been able to validate them. The process could take several weeks.
"We are still in the process of establishing protocols with cooperation from other hospitals, specifically Northwell's testing lab. We cannot comment any further at this time," said Anthony Boutin, President/CEO, Nassau University Medical. 
Over the weekend, U.S. regulators said there were at least 70 companies distributing these antibody tests. The Association of Public Health Laboratories said it's a "wild west show out there right now.
On NBC's "Meet The Press," the Food and Drug Administration's commissioner expressed concern over the situation.
On Monday, Suffolk Executive Steve Bellone said the county has not yet purchased any of the antibody tests.
"We've had many discussions about antibody testings since the beginning, that's something we're looking at very closely," says Bellone. "We know that there are many trials around the state right now, we are going to be waiting to see what the results of those trials are."
A spokesman for Northwell Health Labs says scientists there are working this week to validate a number of the antibody blood tests, including tests purchased from Long Island-based Henry Schein.
 


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