What are the CDC and American Association for Clinical Chemistry (AACC) guidelines for the use of coronavirus disease 2019 (COVID-19) antibody detection tests?

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

Answer

The CDC has published interim guidelines for COVID-19 antibody testing, with recommendations that include preferential use of antibody assays that were granted EUA by the FDA. [59] Specific recommendations have been made with regard to maximizing the PPV of antibody detection tests; guidelines include performing serology testing on individuals with a high pretest probability of prior infection and employing antibody assays with high specificity. Moreover, the CDC recommends implementing a two-step/orthogonal testing algorithm involving two independent tests, with an initial positive result being confirmed by a different antibody assay. [59] The CDC strongly recommends interpretation of antibody test results in correlation with a patient's clinical history and that the results be interpreted and reported with caution.

Similar to the CDC, the American Association for Clinical Chemistry (AACC) recommends the use of assays that have received EUA by the FDA or laboratory-developed tests (LDTs) that have been developed and validated by high-complexity, CLIA-certified laboratories. At-home serology testing is not supported by the AACC at this time. [69]


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