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FDA authorizes new Covid-19 antibody test that quantifies specific levels of antibodies

November 25, 2020. Summarized by summa-bot.

The US Food and Drug Administration has issued an emergency use authorization for Kantaro Bioscience's Covid-19 antibody test kit, the group announced on Wednesday. The newly authorized antibody test, called COVID-SeroKlir, identifies and measures precise levels of antibodies that are present in a person after Covid-19 recovery.

"Being able to measure a patient's relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean," Dr. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in a news release in July around the time the tests were authorized.

While the newly authorized Covid-19 antibody test is similar to others in that it detects Covid-19 antibody levels, it takes testing a step further by providing a number readout of the level detected -- and not just a simple positive or negative result, said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security, who was not involved in the Kantaro test.

Studies suggest that Covid-19 antibody levels can dwindle over time -- after a period of about five to six months -- but more research is needed, said Dr. Saju Mathew, an Atlanta-based primary care physician and public health specialist, who was not involved in the newly authorized Kantaro test.

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