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FDA authorizes first check that screens for Covid-neutralizing antibodies

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Truck driver Oswaldo Monroy, 62, is examined for COVID-19 at an International Brotherhood of Teamsters testing web site, because the unfold of the coronavirus illness (COVID-19) continues, in Wilmington, close to the Port of Los Angeles, California, June 25, 2020.

Lucy Nicholson | Reuters

The Food and Drug Administration introduced on Friday that it has approved the primary serology check that screens for neutralizing antibodies brought on by a earlier coronavirus an infection.

Neutralizing antibodies stop viruses from infecting cells, although questions stay about how lengthy antibodies towards Covid-19 final and the way a lot safety they supply. The new serology check will assist researchers research the neutralizing antibodies, mentioned Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health within the FDA’s Center for Devices and Radiological Health.

“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies may mean for patients as we continue the fight against COVID-19,” he mentioned in an announcement. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorization gives us another tool to evaluate those antibodies as we continue to research and study this virus.”

Patients and well being suppliers shouldn’t interpret the optimistic outcomes of the check to imply that sufferers are protected towards Covid-19, the company mentioned. They ought to nonetheless comply with public well being precautions, the FDA mentioned.

The FDA granted the emergency use authorization to GenScript USA, which manufactures the check.

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