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. 2023 May 3;76(9):1678-1680.
doi: 10.1093/cid/ciad025.

Accelerating Human Immunodeficiency Virus Self-Testing in the United States: A Call to Action

Stephany Ma  1 , Robin J MacGowan  2 , Jonathan H Mermin  2 , S Michele Owen  2 , Yukari C Manabe  1
Affiliations

Accelerating Human Immunodeficiency Virus Self-Testing in the United States: A Call to Action

Stephany Ma et al. Clin Infect Dis. .

Abstract

Human immunodeficiency virus (HIV) self-testing has emerged as a tool to increase the proportion of people to know their status. Since the first HIV self-test was approved in 2012 by the US Food and Drug Administration (FDA), global access to HIV self-tests has been bolstered by public-private partnerships to ensure equitable access in low- and middle-income countries. However, no company has applied for FDA clearance in a decade. We highlight the potential benefits to reclassifying HIV self-tests from class III to class II.

Keywords: HIV; HIVST; diagnostics; prevention; self-testing.

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Conflict of interest statement

Potential conflicts of interest. S. M. O. reports the following patent: Detection of HIV-1 nucleic acids by reverse-transcription loop-mediated isothermal amplification (patent no. 10697028; 30 June 2020); currently no money has been received for this patent, but it could be considered a diagnostic method. Y. C. M. reports consulting fees paid to the author from Abbott; a leadership or fiduciary role on the Infectious Diseases Institute board; and research grant support to Johns Hopkins University from Hologic, Cepheid, Roche, ChemBio, Becton Dickinson, and miDiagnostics. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Comment in

References

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