How are coronavirus disease 2019 (COVID-19) antibody detection tests validated?

Updated: Apr 02, 2021
  • Author: James J Dunn, PhD, D(ABMM), MT(ASCP); more...
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Answer

Answer

The FDA has issued EUAs for SARS-CoV-2 antibody tests using serum, plasma, or whole blood; [9]  it has also required commercial manufacturers who develop COVID-19 antibody tests to submit EUA requests together with an assay’s validation data. An updated list of serology tests that received EUA, along with their diagnostic specifications/test performance (including assay specificity, sensitivity, positive predictive value [PPV], and NPV), is available on the FDA website. [9] The FDA is actively involved in evaluation of the accuracy of serology tests.


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