Evaluation of Abbott Fourth Generation HIV Antigen and Antibody Assays

Hee Jung Kang; Kyeong Ha Yoo; Han Sung Kim; Hyoun Chan Cho

doi:10.3343/kjlm.2006.26.1.39

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Kang, Yoo, Kim, and Cho: Evaluation of Abbott Fourth Generation HIV Antigen and Antibody Assays

Original Article

Korean J Leg Med 2006;26(1):39-44.

Published online: 10 February 2006

DOI: https://doi.org/10.3343/kjlm.2006.26.1.39

Evaluation of Abbott Fourth Generation HIV Antigen and Antibody Assays

Hee Jung Kang, M.D.^1,², Kyeong Ha Yoo, M.T.², Han Sung Kim, M.D.^1,², Hyoun Chan Cho, M.D.¹

¹Department of Laboratory Medicine, Hallym University College of Medicine, Anyang, Korea

²Department of Laboratory Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea

Received 31 May 2005 Accepted 9 February 2006

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

In order to reduce the diagnostic window period between the time of human immunodeficiency virus (HIV) infection and serological diagnosis, new fourth generation screening assays which detect HIV p24 antigen and specific antibody simultaneously have been developed. In this study, we evaluated the performance of a new fourth generation assay.

Methods

We compared a new fourth generation assay, Architect HIV Ag/Ab combo, with another fourth generation assay AxSYM HIV Ag/Ab combo and a third generation assay, AxSYM HIV 1/2 gO for their performance. The assays were evaluated using 3 HIV seroconversion panels, 305 sera of healthy subjects and 100 sera of patients with HBsAg or anti-HCV antibodies. Within-run and total coefficient variations of the three screening assays were analyzed for the evaluation of precision.

Results

Architect HIV Ag/Ab combo shortened the window period by 8.7±2.1 days relative to AxSYM HIV 1/2 gO and 2.0±2.0 days relative to AxSYM HIV Ag/Ab combo in seroconversion panels. Architect HIV Ag/Ab combo presented the best performance in precision among the three reagents; total CV for positive control was 3.6%, 9.6% and 4.6% for Architect HIV Ag/Ab combo, AxSYM HIV Ag/Ab combo and AxSYM HIV 1/2 gO, respectively. Specificities of three assays were not different in this study.

Conclusions

HIV Ag/Ab combined assays reduced the diagnostic window as compared to the third generation screening assays, enabling an earlier diagnosis of HIV infection. A new fourth generation assay, Architect HIV Ag/Ab combo presents a better performance than AxSYM HIV Ag/Ab combo, showing improved seroconversion sensitivity and precision.

Keywords: HIV, Combined antigen/antibody test, Diagnosis

References

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4. Gurtler L, Muhlbacher A, Michl U, Hofmann H, Paggi GG, Bossi V, et al. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. J Virol Methods. 1998; 75:27–38.

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Table 1.

Comparison of the performance of the AxSYM HIV 1/2 gO, AxSYM HIV Ag/Ab combo and Architect HIV Ag/Ab combo in seroconversion panels

Panels	Days since 1st bleed	AxSYM 1/2 gO (S/CO)	AxSYM HIV Ag/Ab combo (S/CO)	Architect HIV Ag/Ab combo (S/CO)
PRB951	0	0.54	0.52	0.11
	2	0.46	0.47	0.09
	8	0.44	1.49	2.88
	11	0.45	10.46	31.81
	15	0.59	38.27	227.74
	19	5.70	18.80	63.64
PRB953	0	0.46	0.42	0.12
	3	0.49	0.82	1.01
	7	0.78	4.61	11.89
	10	12.86	15.16	32.69
PRB958	0	0.37	0.37	0.10
	2	0.38	0.31	0.13
	7	0.36	0.76	2.89
	9	0.39	1.34	7.71
	15	4.51	5.83	17.18
	17	9.72	10.96	29.80

The figures in bold print represent results determined as reactive.

Abbreviation: S/CO, sample/cutoff.

Table 2.

Results of three HIV screening assays in the sera of 305 healthy subjects and 100 patients with HBsAg or anti-HCV antibodies

	Healthy (N=305)			HBsAg or anti-HCV positive (N=100)
	AxSYM 1/2 gO (S/CO)	AxSYM HIV Ag/Ab combo (S/CO)	Architect HIV Ag/Ab combo (S/CO)	AxSYM 1/2 gO (S/CO)	AxSYM HIV Ag/Ab combo (S/CO)	Architect HIV Ag/Ab combo (S/CO)
Mean	0.34	0.33	0.10	0.38	0.36	0.12
Min	0.28	0.26	0.05	0.30	0.28	0.07
Max	0.53	0.45	0.25	0.61	0.48	0.26

Abbreviation: See Table 1.

Table 3.

Comparison of the precision of three HIV screening assays

	AxSYM 1/2 gO		AxSYM HIV Ag/Ab combo		Architect HIV Ag/Ab combo
	S/CO (mean ±SD)	CV (%)	S/CO (mean ±SD)	CV (%)	S/CO (mean ±SD)	CV (%)
Within-run precision
Pooled sera	0.35±0.014	4.1	0.34±0.013	3.9	0.10±0.011	10.5
Negative control	0.42±0.020	4.8	0.42±0.018	4.3	0.08±0.011	13.3
Positive control	4.66±0.150	3.2	2.21±0.088	4.0	3.43±0.089	2.6
Total precision
Pooled sera	0.35±0.020	5.8	0.34±0.019	5.6	0.10±0.013	12.4
Negative control	0.42±0.029	6.8	0.42±0.020	4.8	0.08±0.013	15.7
Positive control	4.66±0.213	4.6	2.21±0.206	9.3	3.43±0.122	3.6

Abbreviation: See Table 1.

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