Home HIV Testing: Good News but Not a Game Changer
Authors: A. David Paltiel, Rochelle P. Walensky
Journal: Annals of Internal Medicine (2012)

Ideas and Opinions20 November 2012Home HIV Testing: Good News but Not a Game ChangerA. David Paltiel, PhD and Rochelle P. Walensky, MD, MPHA. David Paltiel, PhDFrom the Yale School of Public Health and the Yale School of Management, New Haven, Connecticut, and the Medical Practice Evaluation Center, Massachusetts General Hospital, and the Center for AIDS Research, Harvard Medical School, Boston, Massachusetts. and Rochelle P. Walensky, MD, MPHFrom the Yale School of Public Health and the Yale School of Management, New Haven, Connecticut, and the Medical Practice Evaluation Center, Massachusetts General Hospital, and the Center for AIDS Research, Harvard Medical School, Boston, Massachusetts.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-157-10-201211200-00545 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail On 3 July 2012, the U.S. Food and Drug Administration (FDA) approved the OraQuick In-Home HIV Test (OraSure Technologies, Bethlehem, Pennsylvania) to detect antibodies to HIV types 1 and 2. This test will soon be available for sale both online and at more than 30 000 retail outlets nationwide. This is the first truly over-the-counter home HIV testing kit, the same test that professionals have used in health care and community-based settings since its approval in 2004. The test provides simple, accurate, in-home detection of HIV infection in 20 minutes using an oral fluid sample (1, 2).Public response to the ...References1. U.S. Food and Drug Administration. Vaccines, Blood & Biologics. Information Regarding the OraQuick In-Home HIV Test. Accessed at www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/ucm311895.htm on 6 August 2012. Google Scholar2. Pant Pai N, Balram B, Shivkumar S, Martinez-Cajas JL, Claessens C, Lambert G, et al. Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12:373-80. [PMID: 22277215] CrossrefMedlineGoogle Scholar3. Sax PE. Journal Watch Blogs. HIV and ID Observations. Accessed at http://blogs.jwatch.org/hiv-id-observations/.index.php/home-hiv-test-big-news-but-why-and-what-impact-will-it-have/2012/07/05/ on 6 August 2012. Google Scholar4. McNeil DG. Rapid H.I.V. home test wins federal approval. New York Times. 4 July 2012:A1. Accessed at www.nytimes.com/2012/07/04/health/oraquick-at-home-hiv-test-wins-fda-approval.html?_r=2&src=me&ref=health on 6 August 2012. Google Scholar5. Walensky RP, Paltiel AD. Rapid HIV testing at home: does it solve a problem or create one? Ann Intern Med. 2006;145:459-62. [PMID: 16983134] LinkGoogle Scholar6. Paltiel AD, Pollack HA. Price, performance, and the FDA approval process: the example of home HIV testing. Med Decis Making. 2010;30:217-23. [PMID: 19429837] CrossrefMedlineGoogle Scholar7. Branson BM. Home sample collection tests for HIV infection. JAMA. 1998;280:1699-701. [PMID: 9832003] CrossrefMedlineGoogle Scholar8. Branson BM, Handsfield HH, Lampe MA, Janssen RS, Taylor AW, Lyss SB, et al; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55 RR-14 1-17. [PMID: 16988643] MedlineGoogle Scholar9. Branson BM. The future of HIV testing. J Acquir Immune Defic Syndr. 2010;55 Suppl 2 S102-5. [PMID: 21406978] CrossrefMedlineGoogle Scholar10. Centers for Disease Control and Prevention (CDC). HIV surveillance—United States, 1981-2008. MMWR Morb Mortal Wkly Rep. 2011;60:689-93. MedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: A. David Paltiel, PhD; Rochelle P. Walensky, MD, MPHAffiliations: From the Yale School of Public Health and the Yale School of Management, New Haven, Connecticut, and the Medical Practice Evaluation Center, Massachusetts General Hospital, and the Center for AIDS Research, Harvard Medical School, Boston, Massachusetts.Acknowledgment: The authors thank Paul E. Sax, MD, for helpful comments on an earlier draft of the manuscript.Grant Support: The authors are funded by the National Institute of Allergy and Infectious Diseases (R37 AI42006, P30 AI060354), the National Institute of Mental Health (R01 MH65869), and the National Institute on Drug Abuse (R01 DA015612).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1975.Corresponding Author: A. David Paltiel, PhD, Yale School of Public Health, 60 College Street, Room 305, New Haven, CT 06520-8034; e-mail, [email protected].Current Author Addresses: A. David Paltiel, PhD, Yale School of Public Health, 60 College Street, PO Box 208034, New Haven, CT 06520-8034.Rochelle P. Walensky, MD, MPH, Massachusetts General Hospital, 50 Staniford Street, 9th Floor, Boston, MA 02114.Author Contributions: Conception and design: A.D. Paltiel, R.P. Walensky.Drafting of the article: A.D. Paltiel, R.P. Walensky.Critical revision of the article for important intellectual content: A.D. Paltiel, R.P. Walensky.Final approval of the article: A.D. Paltiel, R.P. Walensky.Provision of study materials or patients: R.P. Walensky.Obtaining of funding: A.D. Paltiel.Administrative, technical, or logistic support: A.D. Paltiel, R.P. Walensky.Collection and assembly of data: R.P. Walensky.This article was published at www.annals.org on 9 October 2012. 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