COVID-19 Self-Test Data: Challenges and Opportunities — United States, October 31, 2021–June 11, 2022
Matthew D. Ritchey, Hannah G. Rosenblum, Kim Del Guercio, Matthew A. Humbard, Steven Santos, Jason P. W. Hall, Jasmine Chaitram, Reynolds M. Salerno
Abstract
Self-tests* to detect current infection with SARS-CoV-2, the virus that causes COVID-19, are valuable tools that guide individual decision-making and risk reduction (1-3). Increased self-test use (4) has likely contributed to underascertainment of COVID-19 cases (5-7), because unlike the requirements to report results of laboratory-based and health care provider-administered point-of-care COVID-19 tests, public health authorities do not require reporting of self-test results. However, self-test instructions include a recommendation that users report results to their health care provider so that they can receive additional testing and treatment if clinically indicated. In addition, multiple manufacturers of COVID-19 self-tests have developed websites or companion mobile applications for * The first self-test was authorized by the Food and Drug Administration (FDA) for emergency use in December 2020. As of May 2022, FDA had authorized 20 self-tests (https://www.fda.gov/medical-devices/coronavirus-covid-19-andmedical-devices/home-otc-covid-19-diagnostic-tests). Self-tests are also referred to as home tests, at-home tests, or over-the-counter tests. Self-test data reflect primarily antigen test results but can include nucleic acid amplification test (NAAT) results. https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html Laboratory-based and point-of-care NAAT and antigen test results were identified and classified based on Logical Observation Identifiers Names and Codes identifiers. Laboratory-based and point-of-care test data include NAAT results; setting type for NAAT administration cannot be distinguished based on available data. Point-of-care test result data also include antigen tests administered in settings operating under a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. Reporting of all NAAT results is required of facilities with CLIA certification to perform moderate-or highcomplexity tests; however, reporting of negative results for point-of-care antigen test results is no longer required, which might artificially inflate percent positivity calculations. https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/ HHS-Laboratory-Reporting-Guidance-508.pdf As part of their Emergency Use Authorization request submission to FDA, self-test manufacturers were requested to describe how all test users could report all test results to public health and other authorities to whom reporting was required, in accordance with local, state, and federal requirements. In addition, some state and local jurisdictions also established mechanisms for persons to voluntarily report self-test results. users to voluntarily report self-test result data. Federal agencies use the data reported to manufacturers, in combination with manufacturing supply chain information, to better understand self-test availability and use. This report summarizes data voluntarily reported by users of 10.7 million self-tests from four manufacturers during October 31, 2021-June 11, 2022, and compares these self-test data with data received by CDC for 361.9 million laboratory-based and point-of-care tests performed during the same period. Overall trends in reporting volume and percentage of positive results, as well as completeness of reporting demographic variables, were similar INSIDE