Korean J Clin Microbiol.  2009 Sep;12(3):116-121. 10.5145/KJCM.2009.12.3.116.

Evaluation of OraQuick Advance Rapid HIV-1/2 Antibody Test as a Screening Test for HIV Infection

Affiliations
  • 1Department of Laboratory Medicine, Soonchunhyang University Hospital, Seoul, Korea. choity@hosp.sch.ac.kr
  • 2Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea.

Abstract

BACKGROUND
For the diagnosis of HIV infection, enzyme immunoassay (EIA) or chemiluminescence immunoassay (CLIA) is commonly used as a screening test. Although these methods have a high sensitivity and low cost, their high false positive rate can cause confusion in the patients and clinicians until a more specific test is done. OraQuick Advance Rapid HIV-1/2 Antibody Test (OraQuick) (OraSure Technologies, USA) is a rapid test that can detect HIV-1/2 antibodies in 20 minutes. It uses oral fluid, whole blood or serum sample. In this study, we evaluated the usefulness of the OraQuick as a screening and point-of-care test for HIV infection.
METHODS
From Jan 2007 to Dec 2008, 45,276 samples referred to our laboratory were tested by CLIA method using the ADVIA Centaur (Bayer Healthcare LTD., USA) for HIV-1/2 antibody detection. Among them, 74 positive and 50 negative samples were tested by the Western immunoblot assay (WIB) and OraQuick test as a case-control study. Also, oral fluids from 30 HIV patients and 48 healthy persons were tested by OraQuick test.
RESULTS
The sensitivity and specificity of OraQuick test (using serum samples) were 100% and 98.8% (95% confidence interval 96.9~100%), respectively. OraQuick tests (using oral fluid samples) were all positive for HIV patients but all negative for healthy persons.
CONCLUSIONS
This study suggests that OraQuick can be used successfully as a rapid test for the early detection of HIV-1/2 antibody in patients visiting emergency departments and for the prevention of HIV infection in the health care providers.

Keyword

HIV-1/2 antibody; OraQuick test; Rapid test; Infection control

MeSH Terms

Antibodies
Blotting, Western
Case-Control Studies
Delivery of Health Care
Emergencies
HIV
HIV Infections
Humans
Immunoassay
Immunoenzyme Techniques
Infection Control
Luminescence
Mass Screening
Sensitivity and Specificity
Antibodies

Reference

1. Korean alliance to defeat AIDS. http://www.aids.or.kr/front/library/library_infectee_info.asp[Online. (last visited on 15 January 2009).
2. Cha YJ, Kwon SY, Kim TY, Kim JR, Kim HS, Park MH, et al. Annual report on external quality assessment in immunoserology in Korea (2007). J Lab Med Qual Assur. 2008; 30:49–74.
3. Kang HJ, Yoo KH, Kim HS, Cho HC. Evaluation of Abbott fourth generation HIV antigen and antibody assays. Korean J Lab Med. 2006; 26:39–44.
Article
4. Kim JM, Song YG. Diagnosis and clinical manifestations of HIV/AIDS. J Korean Med Assoc. 2007; 50:303–15.
Article
5. Centers for Disease Control and Prevention. Approval of a new rapid test for HIV antibody. MMWR Morb Mortal Wkly Rep. 2002; 51:1051–2.
6. Delaney KP, Branson BM, Uniyal A, Kerndt PR, Keenan PA, Jafa K, et al. Performance of an oral fluid rapid HIV-1/2 test: experience from four CDC studies. AIDS. 2006; 20:1655–60.
Article
7. Wesolowski LG, MacKellar DA, Facente SN, Dowling T, Ethridge SF, Zhu JH, et al. Post-marketing surveillance of OraQuick whole blood and oral fluid rapid HIV testing. AIDS. 2006; 20:1661–6.
Article
8. van Helden J, Denoyel G, Freeman J, Preisel-Simmons B. Performance of a new HIV 1/O/2 assay on the Bayer ADVIA Centaur immunoassay system. Clin Lab. 2004; 50:83–90.
9. Schappert J, Wians FH Jr, Schiff E, Smalley D, Gambardella R, Lee WM, et al. Multicenter evaluation of the Bayer ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay. Clin Chim Acta. 2006; 372:158–66.
Article
10. Landrum ML, Wilson CH, Perri LP, Hannibal SL, O'Connell RJ. Usefulness of a rapid human immunodeficiency virus-1 antibody test for the management of occupational exposure to blood and body fluid. Infect Control Hosp Epidemiol. 2005; 26:768–74.
Article
11. Jafa K, Patel P, Mackellar DA, Sullizan PS, Delaney KP, Sides TL, et al. Investigation of false positive results with on oral fluid rapid HIV-1/2 antibody test. PLoS ONE. 2007; 2:e185.
12. Ehrenkranz PD, Ahn CJ, Metlay JP, Camargo CA Jr, Holmes WC, Rothman R. Availability of rapid human immunodeficiency virus testing in academic cmergency departments. Acad Emerg Med. 2008; 15:144–50.
13. Walensky RP, Arbelaez C, Reichmann WM, Walls RM, Katz JN, Block BL, et al. Revising expectations from rapid HIV tests in the emergency department. Ann Intern Med. 2008; 149:153–60.
Article
14. Seo DW, Lim KS, Lee JH, Youn JC, Kim W. Analysis of undiagnosed HIV-positive patients in the emergency room. J Korean Soc Emerg Med. 2003; 14:258–63.
15. Kim TY, Suh GJ, Kwak YH. Clinical features of emergency department visits by patients infected with human immunodeficiency virus and need for infection control. J Korean Soc Emerg Med. 2005; 16:458–66.
16. Walensky RP, Paltiel AD, Losina E, Mercincavage LM, Schackman BR, Sax PE, et al. The survival benefits of AIDS treatment in the United States. J Infect Dis. 2006; 194:11–9.
Article
17. Doyle NM, Levison JE, Gardner MO. Rapid HIV versus enzyme-linked immunosorbent assay screening in a low-risk Mexican American population presenting in labor: a cost-effectiveness analysis. Am J Obstet Gynecol. 2005; 193:1280–5.
Article
18. Oh HS, Choe KW. Descriptive study of reported bloodborne exposures in health care workers in a university hospital. Korean J Nosocomial Infect Control. 2002; 7:51–64.
19. Park MR, Kim JE, Park ES, Choi JS, Jung SY, Song YG, et al. A multicenter descriptive study of bloodborne exposures among health care workers in Seoul and Gyeonggi-do. Korean J Nosocomial Infect Control. 2003; 8:35–45.
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