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A rapid review of rapid HIV antibody tests

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Abstract

Rapid HIV antibody tests recently approved by the Food and Drug Administration can help reduce unrecognized infections by improving access to testing in both clinical and nonclinical settings and increase the proportion of those tested who learn their results. Four rapid HIV antibody tests are now available in the United States; two are approved for use at point-of-care sites outside a traditional laboratory. All four tests are interpreted visually. Sites offering rapid HIV testing must periodically run external controls (known HIV-positive and HIV-negative specimens) and provide persons who undergo rapid testing a subject information sheet. This paper reviews the operating and performance characteristics, quality assurance and laboratory requirements, and HIV counseling implications of the currently available rapid HIV tests.

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References and Recommended Reading

  1. Glynn M, Rhodes P: Estimated HIV Prevalence in the United States at the end of 2003 [abstract T1-B1101]. Paper presented at the 2005 National HIV Prevention Conference. Atlanta, GA; June 12–15, 2005.

  2. Samet JH, Freedberg KA, Savetsky JB, et al.: Understanding delay to medical care for HIV infection: the long-term non-presenter. AIDS 2001, 15:77–85.

    Article  PubMed  CAS  Google Scholar 

  3. Valleroy LA, MacKellar DA, Karon JM, et al.: HIV prevalence and associated risks in young men who have sex with men. Young Men’s Survey Study Group. JAMA 2000, 284:198–204.

    Article  PubMed  CAS  Google Scholar 

  4. Centers for Disease Control and Prevention: HIV/AIDS Surveillance Report 2002; 14:Table 1. http://www.cdc. gov/hiv/stats/hasrlink.htm. Accessed November 2, 2004.

  5. Klein D, Hurley LB, Merrill D, Quesenberry CP Jr: Review of medical encounters in the 5 years before a diagnosis of HIV-1 infection: Implications for early detection. J Acquir Immune Defic Syndr 2003, 32:143–152.

    PubMed  Google Scholar 

  6. Centers for Disease Control and Prevention: Late versus early testing of HIV-6 Sites, United States, 2000–2003. MMWR 2003, 52:581–586.

    Google Scholar 

  7. Tao G, Branson BM, Kassler WJ, Cohen RA: Rates of receiving HIV test results: data from the U.S. National Health Interview Survey for 1994 and 1995. J Acquir Immune Defic Syndr 1999, 22:395–400.

    PubMed  CAS  Google Scholar 

  8. Centers for Disease Control and Prevention: Advancing HIV Prevention: new strategies for a changing epidemic —United States, 2003. MMWR 2003, 52:329–332.

    Google Scholar 

  9. Centers for Disease Control and Prevention: Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993, 42:RR-02.

    Google Scholar 

  10. OraQuick Advance Rapid HIV-1/2 Antibody Test [package insert]. Bethlehem, PA: OraSure Technologies, Inc.; 2004. Available at http//:www.orasure.com.

  11. Bulterys M, Jamieson DJ, O’Sullivan MJ, et al.: Rapid HIV-1 testing during labor: a multicenter study. JAMA 2004, 292:219–223. The authors demonstrate that rapid HIV testing is feasible and delivers accurate and timely test results for women in hospitalbased labor and delivery wards.

    Article  PubMed  CAS  Google Scholar 

  12. Greenwald JL, Pincus J: Rapid HIV testing in the era of OraQuick®. Today’s Therapeutic Trends 2003, 21:307–344.

    Google Scholar 

  13. Kroc KA, GR Papiez GR, Parks DI, et al.: Routine screening of emergency department (ED) patients using OraQuick Rapid HIV-1 Antibody Test [abstract #M3-L103]. Paper presented at the 2003 National HIV Prevention Conference. Atlanta, GA; July 22–30, 2003.

  14. Kelen GD, Shahan JB, Quinn TC: Emergency departmentbased HIV screening and counseling: experience with rapid and standard serologic testing. Ann Emerg Med 1999, 33:147–155.

    Article  PubMed  CAS  Google Scholar 

  15. Walensky RP, Losina E, Steger-Craven KA, Freedberg KA: Identifying undiagnosed human immunoDeficiency virus: The yield of routine, voluntary inpatient testing. Arch Intern Med 2002, 162:887–892.

    Article  PubMed  Google Scholar 

  16. MacGowan R, McKeever J, Stodola J, et al.: Multi-site demonstration project implementing rapid HIV testing jails [abstract #WO-C1401]. Paper presented at the 2005 National HIV Prevention Conference. Atlanta, GA: June 12–15, 2005.

  17. Salgado CD, Flanagan HL, Haverstick DM, Farr BM: Low rate of false-positive results with use of a rapid HIV test. Infect Control Hosp Epidemiol 2002, 23:335–337.

    Article  PubMed  Google Scholar 

  18. Kallenborn JC, Price TG, Carrico R, Davidson AB: Emergency department management of occupational exposures: cost analysis of rapid HIV test. Infect Control Hosp Epidemiol 2001, 22:289–293.

    Article  PubMed  CAS  Google Scholar 

  19. King AM, Osterwalder JJ, Vernazza PL: A randomised prospective study to evaluate a rapid HIV-antibody assay in the management of cases of percutaneous exposure amongst health care workers. Swiss Medical Weekly 2001, 131:10–13.

    PubMed  CAS  Google Scholar 

  20. Military sealift command anthrax/smallpox meeting with industry. Monday, February 24, 2003. Washington Navy Yard, Bldg 220. http://www.msc.navy.mil/n10/ 022403meeting.htm. Accessed September 3, 2004.

  21. United States Food and Drug Administration: Premarket approval information-devices. http://www.fda.gov/cber/ pmaltr/P00002315L.htm. Accessed June 2, 2005.

  22. Reveal Rapid HIV-1 Antibody Test [package insert]. Halifax, Nova Scotia, Canada: MedMira Laboratories, Inc.; 2004. Available at http//:www.reveal-hiv.com.

  23. Trinity Biotech: Trinity Biotech receives CLIA waiver for Uni-Gold Recombigen® HIV test [press release]. June 30, 2004. http//:www.trinitybiotech.com/data/press/30-06-04.pdf. Accessed September 3, 2004.

  24. Trinity Biotech: Uni-Gold Recombigen® HIV. Summary of safety and effectiveness. http://www.fda.gov/cber/pmasumm/ P0300250S.pdf. Accessed September 3, 2004.

  25. Multispot HIV-1/HIV-2 Rapid Test [package insert]. Redmond, WA: Bio-Rad Laboratories; 2004. Available at http//:www.bio-rad.com.

  26. Genetic Systems TM HIV-1/HIV-2 Peptide EIA [package insert]. Redmond, WA: Bio-Rad Laboratories Blood Virus Division; 2000.

  27. Genetic Systems TM rLAV EIA [package insert]. Redmond, WA: Bio-Rad Laboratories Blood Virus Division; 2000.

  28. Vironostica HIV-1 Microelisa System [package insert]. Durham, NC: Organon Teknika Corporation; 1994.

  29. Health Research and Education Trust (HRET): Charts for comparing rapid HIV antibody screening tests. http://www.hret.org/hret/programs/hivtransmrpd.html. Accessed June 28, 2005.

  30. Centers for Disease Control and Prevention: Revised guidelines for HIV counseling, testing, and referral. MMWR 2001, 50(RR-19):1–57.

    Google Scholar 

  31. O’Connell RJ, Merritt TM, Malia JA, et al.: Performance of the OraQuick rapid antibody test for diagnosis of human immunoDeficiency virus type 1 infection in patients with various levels of exposure to highly active antiretroviral therapy. J Clin Microbiol 2003, 41:2153–2155.

    Article  PubMed  CAS  Google Scholar 

  32. Centers for Disease Control and Prevention: Quality assurance guidelines for testing using the OraQuick® Rapid HIV-1 antibody test. http://www.cdc.gov/hiv/rapid_testing/materials/ QA-Guide.htm. Accessed October 6, 2004. This document provides guidance on quality assurance practices for sites using or planning to use the OraQuick® Rapid HIV-1 Antibody test to detect antibodies to HIV.

  33. Centers for Disease Control and Prevention: Notice to readers: protocols for con.rmation of reactive rapid HIV tests. MMWR 2004, 53:221–222.

    Google Scholar 

  34. Centers for Disease Control and Prevention: HIV counseling with rapid tests. http://www.cdc.gov/hiv/pubs/rt-counseling.htm. Accessed August 23, 2004.

  35. New York State Department of Health: Counseling protocol for rapid HIV testing sessions. http://www. health.state.ny.us/diseases/aids/testing/rapid/protocol.htm. Accessed July 7, 2005.

  36. Padilla SM, Dillon B, Iatesta M, et al.: Counselor perceptions and impressions of HIV counseling using a rapid HIV test: RESPECT-2. Paper presented at the 2001 National HIV Prevention Conference. Atlanta, GA; August 12–15, 2001.

  37. Elliott R, Jürgens R: Rapid HIV screening at the point of care: Legal and ethical questions. Montréal: Canadian HIV/AIDS Legal Network; 2000. http://www. aidslaw.ca/Maincontent/issues/testing/finalreports/tofc. htm. Accessed July 14, 2005.

    Google Scholar 

  38. Spieldberg F, Branson BM, Goldbaum GM, et al.: Choosing HIV counseling and testing strategies for outreach settings: a randomized trial. J Acquir Immune Defic Syndr 2005, 38:348–355.

    Google Scholar 

  39. Kassler WJ, Dillon BA, Haley C, et al.: On-site, rapid HIV testing with same-day results and counseling. AIDS 1997, 11:1045–1051.

    Article  PubMed  CAS  Google Scholar 

  40. Woodwell DA, Cherry DK: National ambulator y medical care survey: 2002 summar y. Adv Data 2004, 346:1–44.

    PubMed  Google Scholar 

  41. Ekwueme DE, Pinkerton SD, Holtgrave DR, Branson BM: Cost comparison of three HIV counseling and testing technologies. Am J Prev Med 2003, 25:112–121.

    Article  PubMed  Google Scholar 

  42. Valdiserri RO, Moore M, Gerber AR, et al.: A study of clients returning for counseling after HIV testing: implications for improving rates of return. Public Health Rep 1993, 108:12–18.

    PubMed  CAS  Google Scholar 

  43. Burstein GR, Newman DR, San Antonio-Gaddy ML, et al.: Client Preferences for Quick OraQuick Test Results in 3 U.S. States [poster]. Presented at the XV International AIDS Conference. Bangkok, Thailand; July 11–16, 2004.

  44. Birkhead GS, San Antonio-Gaddy ML, Richardson-Moore AL, et al.: Effects of training and field experience on staff confidence and skills for rapid HIV testing in New York State (NYS) [poster]. Presented at the XV International AIDS Conference. Bangkok, Thailand; July 11–16, 2004.

  45. Metcalf CA, Dillon BA, Malotte CK, et al.: Client preferences regarding HIV testing and counseling in STD clinic settings: RESPECT-2. Available at http://www.cdc. gov/hiv/projects/respect-2/slide/testprefpaper.ppt. Accessed March 18, 2005.

  46. American Medical Association: CPT code/value search. Available at https://catalog.ama-assn.org/Catalog/cpt/ cpt_home.jsp. Accessed July 6, 2005.

  47. Centers for Medicare and Medicaid Services: 2005 clinical laboratory fee schedule. http://new.cms.hhs.gov/Clinical-LabFeeSched/CFRC/list.

  48. Centers for Medicare and Medicaid Services: Tests granted waived status under CLIA. http://www.cms.hhs.gov/clia/waivetbl.pdf. Accessed July 11, 2005.

  49. Janssen RS, Holtgrave DR, Valdiserri RO, et al.: The serostatus approach to fighting the HIV epidemic: Prevention strategies for infected individuals. Am J Pub Heal 2001, 91:1019–1024.

    Article  CAS  Google Scholar 

  50. Institute of Medicine: No time to lose: getting more from HIV prevention. Washington, DC: National Academy Press; 2001.

    Google Scholar 

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Correspondence to Jeffrey L. Greenwald MD.

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Greenwald, J.L., Burstein, G.R., Pincus, J. et al. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep 8, 125–131 (2006). https://doi.org/10.1007/s11908-006-0008-6

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