Meta-Analysis for the Pooled Sensitivity and Specificity of anti-Human Immunodeficiency Virus Ab Rapid Tests

Soo Jin Yoo; Yong-Hak Sohn; Sung-Eun Choi; Heung-Bum Oh

doi:10.3343/kjlm.2009.29.4.345

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Yoo, Sohn, Choi, and Oh: Meta-Analysis for the Pooled Sensitivity and Specificity of anti-Human Immunodeficiency Virus Ab Rapid Tests

Original Article

Korean J Leg Med 2009;29(4):345-352.

Published online: 14 January 2009

DOI: https://doi.org/10.3343/kjlm.2009.29.4.345

Meta-Analysis for the Pooled Sensitivity and Specificity of anti-Human Immunodeficiency Virus Ab Rapid Tests

Soo Jin Yoo, M.D.¹, Yong-Hak Sohn, M.D.², Sung-Eun Choi, M.D.², Heung-Bum Oh, M.D.²

¹Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea

²Department of Laboratory Medicine, Universtity of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea

Corresponding author: Heung-Bum Oh, M.D. Department of Laboratory Medicine, Asan Medical Center, 388-1 Pungnap 2-dong, Songpa-gu, Seoul 138-736, Korea Tel: +82-2-3010-4505, Fax: +82-2-478-0884 E-mail: hboh@amc.seoul.kr

Revised 4 Februay 20096 April 2009 Accepted 25 July 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:

Many immunochromatography (ICA) kits for anti-human immunodeficiency virus type (HIV) antibody (Ab) have been introduced to improve the accessibility of HIV Ab tests. However, qualified evaluation reports for HIV rapid tests are not enough to validate their performances. Meta-analysis for the performances of the HIV Ab rapid tests was performed in this study.

Methods:

PubMed database was searched with combination of search terms, ‘human immunodeficiency virus’, ‘HIV Ab’, ‘rapid test’, ‘immunochromatography’, ‘performance’, ‘sensitivity’, and ‘specificity’. Criteria of inclusion were performance studies for HIV ICA kits with serum or EDTA whole blood. Methodological qualities were evaluated with standards for reporting of diagnostic accuracy studies (STARD) checklists by two investigators. Homogeneity among selected studies was evaluated and then pooled sensitivity and specificity were calculated. Positive and negative predictive values were simulated with presumed HIV prevalence in Korea.

Results:

Twenty-three studies were selected from 12 high-qualified papers with STARD checklists. The performance of 23 studies were found to be heterogeneous (P<0.1) and random effect model was used. Pooled sensitivity was 99.71% (95% CI: 99.45-99.97%) and pooled specificity was 99.27% (95% CI: 98.83-99.70%). With HIV prevalence of 0.03%, positive and negative predictive values were presumed to be 3.936% and 99.999%, respectively.

Conclusions:

This meta-analysis for HIV ICA rapid tests showed good performance. In consideration of low positive predictive values of HIV rapid tests, confirmation by enzyme immunoassay or Western blot is still needed. This study would be helpful in evaluating and establishing proper performance guideline for those kits not fully evaluated.

Keywords: HIV, Rapid test, Meta-analysis

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Fig. 1.

Funnel plots for publication bias of sensitivities (A), and specificities (B).

Fig. 2.

Estimates of sensitivity and specificity of HIV Ab rapid tests. Points indicate estimates of sensitivities (A) and specificities (B). Vertical lines are 95% confidence intervals for estimates.

Table 1.

Literature survey on both sensitivity and specificity of HIV Ab rapid test kits using serum or whole blood

Study	Ref	Source of specimen	Reference standard	Test assay	TP	FN	FP	TN	Sn	Sp
Aidoo	[28]	125 AIDS patients, 75 blood donor or antenatal women	PA, WB	Determine HIV-1/2	125	0	0	75	100	100
Arai	[29]	152 HIV-1-infected, 100 HIV-2-infected patients, 368 blood donors	EIA, WB	Determine HIV-1/2	252	0	0	368	100	100
BurgessCassler	[30]	1,541 HIV-positive, 1,387 HIV-negative sera by EIA	EIA, WB	SeroStrip HIV 1/2	1,536	5	4	1,383	99.7	99.7
Ferreira (1)	[31]	400 samples from voluntary counseling center, 500 from antenatal clinics, 200 AIDS patients	EIA, WB	Determine HIV-1/2	221	0	1	878	100	99.9
Ferreira (2)				Hema-Strip HIV-1/2	216	5	0	879	97.7	100
Ferreira (3)				UniGold Recombigen	221	0	0	879	100	100
Foglia (1)	[6]	486 volunteers	EIA, WB,	Oraquick HIV 1	62	0	3	421	100	99.3
Foglia (2)			HIV1 RNA	Determine HIV-1/2	62	0	4	420	100	99.1
Foglia (3)			Monitor	UniGold Recombigen	62	0	0	424	100	100
Foglia (4)				Reveal Rapid HIV-1	61	0	1	423	100	99.8
Ketema	[32]	Stored sera; 988 worldwide, 975 from USA	EIA, WB	Efoora HIV-1/2/O	387	3	2	1,547	99.2	99.9
Menard	[20]	113 HIV-positive and 167 HIV-negative stored sera	EIA, WB	Determine HIV-1/2	113	0	1	166	100	99.4
Menard (1)	[19]	80 HIV-positive and 100 HIV-negative	EIA, WB	HIV 1/2 Quick test	80	0	0	110	100	100
Menard (2)		stored sera		UniGold Recombigen	50	0	1	68	100	98.6
Menard (3)				Retrocheck HIV	100	0	3	145	100	98.0
Menard (4)				SDHO HIV 1/2 test	111	0	2	173	100	98.9
Rouet	[21]	605 antenatal women	EIA, WB	Determine HIV-1/2	49	0	9	547	100	98.4
Urassa	[22]	565 blood donor, 346 antenatal women, 500 general patients	EIA, WB	Determine HIV-1/2	383	0	22	1,007	100	97.9
Van den Berk	[33]	1,160 samples requested for HIV tests	MEIA, Line immunoblot	Determine HIV-1/2	161	1	4	994	99.4	99.6
Eller (1)	[34]	940 blood donor	EIA, WB,	Determine HIV-1/2	10	0	35	895	100	96.2
Eller (2)			HIV 1 RNA	UniGold Recombigen	10	0	8	922	100	99.1
Eller (3)			Monitor	Oraquick HIV 1/2	10	0	2	928	100	99.8
Eller (4)				HIV 1/2 STAT-PAK	10	0	3	927	100	99.7

Abbreviations: TP, true positive; FN, false negative; FP, false positive; TN, true negative; Sn, sensitivity; Sp, specificity; PA, particle agglutination assay; WB, Western blot assay; EIA, enzyme immunoassay; RQ-PCR, real-time quantitative polymerase chain reaction; MEIA, microparticle enzyme immunoassay.

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