ABSTRACT
INTRODUCTION: HIV self-testing (HIVST), whereby an individual performs and interprets their own rapid screening test at home, is another tool to increase the proportion of at-risk individuals who know their status. Globally, HIVST has rapidly been adopted through global partnerships to ensure equitable access to tests in low- and middle-income countries (LMIC). AREA COVERED: This review discusses the regulatory burdens of HIV self-testing within the United States while examining the use of HIV self-tests on a global scale. While the United States only has one approved HIV self-test, numerous tests have been prequalified by the WHO. EXPERT OPINION: Despite the US Food and Drug Administration (FDA) clearance of the first and only self-test in 2012, there have been no other tests that have undergone FDA consideration due to regulatory barriers. This, in turn, has stifled market competition. Despite existing evidence that such programs are an innovative approach to testing hesitant or hard-to-reach populations, high individual test cost and bulky packaging make large-scale, mail-out, and HIV self-testing programs expensive. COVID-19 pandemic has accelerated the public demand for self-testing - HIV self-test programs should capitalize on this to increase the proportion of at-risk people who know their status and are linked to care to contribute to ending the HIV epidemic.