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FDA authorizes first test that screens for Covid neutralizing antibodies


Truck driver Oswaldo Monroy, 62, is tested for COVID-19 at an International Brotherhood of Teamsters testing site, as the spread of the coronavirus disease (COVID-19) continues, in Wilmington, near the Port of Los Angeles, California, June 25, 2020.

Lucy Nicholson | Reuters

The Food and Drug Administration announced on Friday that it has authorized the first serology test that screens for neutralizing antibodies caused by a previous coronavirus infection.

Neutralizing antibodies prevent viruses from infecting cells, though questions remain about how long antibodies against Covid-19 last for and how much protection they provide. The new serology test will help researchers study the neutralizing antibodies, said Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in 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 said in a statement. “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 health providers should not interpret the positive results of the test to mean that patients are protected against Covid-19, the agency said. They should still follow public health precautions, the FDA said.

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



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