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

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.