The recent approval by the United States Food and Drug Administration of a rapid HIV self-test marks a significant milestone in the evolution of HIV testing approaches. With nearly one in five people living with HIV in the United States still undiagnosed and an even higher proportion unaware of their infection globally, this decision reflects a new willingness to offer diverse options to get tested for HIV. Rapid self-testing offers several distinct opportunities to improve testing among those with undiagnosed HIV: to encourage testing among those who might not otherwise be tested, to increase the frequency of testing among persons at highest risk for new infection, and to facilitate mutual HIV testing with sex partners. To date, the path to regulatory approval has been long but instructive. The studies and clinical trials required for regulatory approval in the United States provide insight into the performance and potential implications of HIV self-tests as they become available for sale directly to consumers. Although some persistent reservations about self-testing for HIV remain, including the ‘window period’ of the current test kit, its cost, and its effectiveness for facilitating entry to medical care, others have been dispelled. Self-testing in resource-constrained settings is also promising, including self-testing of health professionals. At present, although the impact has yet to be determined, availability of this new option might offer potential opportunities to improve HIV diagnosis and facilitate both treatment and prevention.
aNew York City Department of Health and Mental Hygiene
bDivision of Infectious Diseases, Department of Medicine, Columbia University Medical Center
cICAP, Mailman School of Public Health, Columbia University, New York
dNational Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Correspondence to Julie E. Myers, MD, MPH, Bureau of HIV/AIDS Prevention and Control, New York City Department of Health and Mental Hygiene, 42-09 28th Street, 22nd floor Queens, New York, NY 11101, USA. Tel: +1 347 396 7761; fax: +1 347 396 7791; e-mail: email@example.com
Received 24 September, 2012
Revised 28 December, 2012
Accepted 5 February, 2013