ASCP to Raise Concern about Over-the-Counter COVID-19 Screening Tests

As part of its goal to support test development, the Food and Drug Administration recently authorized several COVID-19 tests for over-the-counter use without a prescription. While these efforts are important as part of the U.S. pandemic response, particularly to help schools and workplaces screen for COVID-19, ASCP plans to raise concern with FDA about the apparent lack of guidance being linked with these new testing tools.   

These tests may be used in-home by individuals who may not be familiar with the protocols necessary for proper specimen collection, testing and follow-up. The lack of linked available guidance on these topics raises concern about how lay-users will deal with issues such as a negative test result for an individual with signs and symptoms of COVID-19, i.e., a potential false negative result, 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.  

The CDC has provided excellent guidance concerning the interpretation of antigen detection tests for COVID. ASCP is in the process of reaching out to FDA to urge that as these at-home testing devices are authorized that manufacturers be required to ensure that access to available guidance is made available to the purchasers/users of these devices.