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

Tae Youn Choi; Young Ik Seo; Tae Hyong Kim; Jeong Won Shin; Rojin Park

doi:10.5145/KJCM.2009.12.3.116

Journal List > Korean J Clin Microbiol > v.12(3) > 1038163

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Choi, Seo, Kim, Shin, and Park: Evaluation of OraQuick Advance Rapid HIV-1/2 Antibody Test as a Screening Test for HIV Infection

Original Article

Korean J Clin Microbiol 2009;12(3):116-121.

Published online: 22 September 2009

DOI: https://doi.org/10.5145/KJCM.2009.12.3.116

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

¹Department of Laboratory Medicine, Soonchunhyang University Hospital, Seoul, Korea

²Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea

Correspondence: Tae Youn Choi, Department of Laboratory Medicine, Soonchunhyang University Hospital, 657, Hannam-dong, Yong-san-gu, Seoul 140-743, Korea. (Tel) 82-2-709-9425, (Fax) 82-2-790-5820, (E-mail) choity@hosp.sch.ac.kr

Received 28 April 200918 August 2009 Accepted 25 August 2009

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

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

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Table 1.

Comparison between Western immunoblot and OraQuick test

OraQuick test	Western immunoblot
OraQuick test	Negative	Positive
Negative	85	0
Positive	1	34

Abbreviation: OraQuick test, OraQuick advance rapid HIV-1/2 antibody test.

Table 2.

Comparison of anti-HIV 1/2 results among CLIA, OraQuick and WIB tests with serum specimens

		OraQuick test			WIB
		Negative	Weakly positive	Positive	Negative	Indeterminate	Positive
	0.0∼0.9	50^∗			50
	1.0∼9.9	35	1		36
	10.0∼19.9		2	2		2	2
CLIA^† (RLU)	20.0∼29.9			1		1
CLIA^† (RLU)	30.0∼39.9			1			1
	40.0∼49.9			1			1
	≥50.0	1		30		1	30
	Total	86	3	35	86	4	34

^∗ Number of samples;

^† Cutoff index value of CLIA is 1.0 RLU. Abbreviations: CLIA, chemiluminescence immunoassay; OraQuick test, OraQuick advance rapid HIV-1/2 antibody test; WIB, Western immunoblot; RLU, relative light unit.

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