Comparison of Nine Different Qualitative HBsAg Assay Kits

Jinyoung Yang; Jong-Hyun Kim; Yeongsic Kim

doi:10.3343/kjlm.2010.30.2.178

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Yang, Kim, and Kim: Comparison of Nine Different Qualitative HBsAg Assay Kits

Original Article

Korean J Leg Med 2010;30(2):178-184.

Published online: 14 January 2010

DOI: https://doi.org/10.3343/kjlm.2010.30.2.178

Comparison of Nine Different Qualitative HBsAg Assay Kits

Jinyoung Yang, M.D.¹, Jong-Hyun Kim, M.D.², Yeongsic Kim, M.D.¹

¹Departments of Laboratory Medicine, Seoul, Korea

²Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Korea

Corresponding authors: Yeongsic Kim, M.D. Department of Laboratory Medicine, The Catholic University of Korea, St. Vincent's Hospital, 93-6 Ji-dong, Paldal-gu, Suwon 442-723, Korea Tel: +82-31-249-7665, Fax: +82-31-244-6786 E-mail: yeongsik@catholic.ac.kr

Jong-Hyun Kim, M.D. Department of Pediatrics, The Catholic University of Korea, St. Vincent's Hospital, 93-6 Ji-dong, Paldal-gu, Suwon 442-723, Korea Tel: +82-31-249-8206, Fax: +82-31-257-9111 E-mail: jh00mn@catholic.ac.kr

Revised 16 December 20092 February 2010 Accepted 2 February 2010

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:

Qualitative hepatitis B surface antigen (HBsAg) assay kits are still commonly used in Korea where hepatitis B virus (HBV) infection is endemic. The accurate determination of HBsAg plays a crucial role in the diagnosis and prevention of HBV infection, especially in endemic areas. The aim of this study was to compare the detection sensitivities of 9 qualitative HBsAg assay kits.

Methods:

Seven pooled sera with HBsAg concentration ranging from 0.14 IU/mL to 29.96 IU/mL were prepared. The HBsAg concentration of each pooled serum was determined by a quantitative HBsAg assay, Architect HBsAg (Abbott Laboratories, Ireland). The fully automated immunoassay kits included Elecsys HBsAg (Roche Diagnostics, Germany) and Immulite 2000 HBsAg (DPC, USA) and the rapid tests included 5 immunochromatographic assay (ICA) kits and 2 reverse passive hemagglutination assay (RPHA) kits.

Results:

Elecsys HBsAg (Roche Diagnostics) showed positive result in pooled serum with HBsAg concentration of 0.14 IU/mL, but Immulite 2000 HBsAg (DPC) showed negative result in the same concentration. Although ICA kits showed variable results among different assay kits, all of them showed negative results in pooled sera with HBsAg concentration of ≤1.89 IU/mL. Two RPHA kits showed negative results in pooled sera with HBsAg concentration of ≤7.98 IU/mL.

Conclusions:

Although ICAs were more sensitive than RPHAs, they had variable sensitivities for HBsAg and were less sensitive than the automated immunoassay kits. Therefore, ICAs and RPHAs should be used with caution in the screening tests for HBsAg and their sensitivities need to be improved.

Keywords: HBsAg, Immunochromatographic assay, Reverse passive hemagglutination assay

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Fig. 1.

Correlation between HBsAg results measured by Architect HBsAg (IU/mL) and by Immulite 2000 HBsAg (S/CO).

Fig. 2.

Correlation between HBsAg results measured by Architect HBsAg (IU/mL) and by Elecsys HBsAg (COI).

Table 1.

Homogeneity of two pooled sera

Pooled sera	Mean (IU/mL)	SD (IU/mL)	CV (%)
Pooled sera	Mean (IU/mL)	SD (IU/mL)	Within-run	Total
1 (N=20)∗	1.80	0.078	3.57	4.98
2 (N=20)∗	11.5	0.58	4.90	6.14

^∗ Measurements: twice a day, for 20 days.

Table 2.

Comparison of HBsAg results between different qualitative assay kits

Pooled sera	Quantitative			Qualitative
	ARCHIT (IU/mL)	ELEC (COI)	IMMUL (S/CO)	ICA					RPHA
	ARCHIT (IU/mL)	ELEC (COI)	IMMUL (S/CO)	BT	BO	HB	GN	AE	MY	AS
1	0.14	P (0.47)	N (1.55)	N	N	N	N	N	N	N
2	0.47	P (1.54)	P (4.09)	N	N	N	N	N	N	N
3	1.54	P (2.84)	P (12.07)	N	N	N	N	N	N	N
4	1.89	P (10.70)	P (14.68)	N	N	N	N	N	N	N
5	5.73	P (16.55)	P (51.19)	P	P	N	N	N	N	N
6	7.98	P (54.90)	P (73.80)	P	P	P	N	P	N	N
7	29.96	P (129.00)	P (293.60)	P	P	P	P	P	P	N

Abbreviations: ARCHIT, Architect HBsAg; ELEC, Elecsys HBsAg; IMMUL, Immulite 2000 HBsAg; ICA, immunochromatographic assay; RPHA, reverse passive hemagglutination assay; BT, Biotracer HBsAg Rapid Card; BO, Bioline HBsAg; HB, HBsAg Card; GN, Genedia HBsAg Rapid Device; AE, Asan Easy Test HBs Strip; MY, Mycell II HBsAg; AS, Asan HBs; P, positive; N, negative.

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