The FDA approves the primary take a look at searching for Covid-neutralizing antibodies
Truck driver Oswaldo Monroy, 62, is being tested for COVID-19 at an International Brotherhood of Teamsters test site as the spread of coronavirus disease (COVID-19) will take place on June 25th in Wilmington near the port of Los Angeles , California, holds, 2020.
Lucy Nicholson | Reuters
The Food and Drug Administration announced on Friday that it had approved the first serology test that looks for neutralizing antibodies caused by a previous coronavirus infection.
Neutralizing antibodies prevent viruses from infecting cells. However, questions remain as to how long antibodies against Covid-19 last and how much protection they offer. The new serological test will help researchers study the neutralizing antibodies, said Dr. Tim Stenzel, director of the In Vitro Diagnostic and Radiological Health Office at the FDA’s Center for Equipment and Radiological Health.
“The ability to detect neutralizing antibodies can help us gain additional insight into what the existence of antibodies can 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 says about possible immunity, but today’s approval gives us another tool to evaluate these antibodies as we further research and study this virus.”
Patients and healthcare providers should not interpret the positive results of the test to mean that patients are protected against Covid-19, the agency said. You should continue to follow public health precautions, the FDA said.
The FDA cleared GenScript USA, which makes the test, for emergency use.