FDA Approves "New Generation" of COVID-19 Antibody Test that Shows One's Immune Status

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  • The United States Food and Drug Administration (FDA) has authorized one of the first COVID-19 tests that measures the amount of neutralizing antibodies produced by the body's immune system against the SARS-CoV-2 virus that causes COVID-19
  • Unlike previously authorized antibody tests that tell if you've had the virus or not, the COVID-SeroKlir test quantifies the specific levels of COVID-19 neutralizing antibodies
  • However, the FDA has cautioned that much is still unknown about COVID-19 and its immunology, and so a high level of antibodies may not necessarily indicate immunity against the virus
  • The test, however, helps researchers understand the relationship between COVID-19 antibodies and protection against the virus
  • The test was developed by Kantaro Biosciences, a diagnostic startup created by Mount Sinai Health System and Renalytix