ASCP Raises Issue of False Results with FDA

ASCP recently wrote the U.S. Food and Drug Administration (FDA) to voice concern about issues related to test setting and performance metrics for some COVID-19 tests, such as antigen tests. In its letter to the FDA, ASCP wrote that “test setting is of critical importance to test performance and one that we believe requires guidance from the Agency….” “Whether these tests can improve our ability to accurately detect disease depends on how they are used and whether the right tests are used in the right patient care settings, keeping in mind how test performance characteristics and the prevalence of disease affect the positive and negative predictive values,” ASCP said.

ASCP recommended that the FDA specify that “positive results obtained in a low prevalence population (e.g., asymptomatic individuals)” should be initially classified as “provisionally positive” and that these “results should be followed with confirmatory testing, preferably using a RT-PCR test, to eliminate the reporting of false positives.”

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