ASCP recently contacted the U.S. Food and Drug Administration (FDA) urging the Agency to ensure that manufacturers of COVID-19 tests approved for at-home use without a prescription provide users with appropriate guidance on test use and interpretation. In our letter to the Agency, ASCP wrote that “when such testing devices are approved for use by lay users it is imperative that manufacturers be required to provide the users of these devices with appropriate guidance on the use of these devices.”
ASCP noted that these tests “are often used by individuals who may not be familiar with the appropriate protocols for specimen collection, testing issues, and follow-up. When users of these devices use them in a manner inconsistent with available guidance, it increases the likelihood of problems associated with negative test results for symptomatic individuals, i.e., potential false negative results, and positive test results, particularly in asymptomatic individuals, since repetitive testing of asymptomatic individuals will amplify the number of false positive test results that will occur.” ASCP urged the FDA to ensure that manufacturers provide their customers with appropriate guidance, such as that provided by the Centers for Disease Control and Prevention, on the interpretation of antigen detection tests for COVID-19.
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