Annals of Clinical Microbiology, The official Journal of the Korean Society of Clinical Microbiology
Original article

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

Tae Youn Choi1, Young Ik Seo1, Tae Hyong Kim2, Jeong Won Shin1, Rojin Park1

Departments of 1Laboratory Medicine and 2Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea

Corresponding to Tae Youn Choi, E-mail: choity@hosp.sch.ac.kr

Ann Clin Microbiol 2009;12(3):116-121.
Copyright © Korean Society of Clinical Microbiology.

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.

Conclusion: 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. (Korean J Clin Microbiol 2009;12:116-121)

Keywords

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