Evaluation of Indigenously Manufactured Immunochromatographic Assay Systems for Rapid Detection of Hepatitis B Surface Antigen and Antibody

Young Joo Cha; Joo Suk Yang; Seok Lae Chae

doi:10.3343/kjlm.2006.26.1.52

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Cha, Yang, and Chae: Evaluation of Indigenously Manufactured Immunochromatographic Assay Systems for Rapid Detection of Hepatitis B Surface Antigen and Antibody

Original Article

Korean J Leg Med 2006;26(1):52-57.

Published online: 10 February 2006

DOI: https://doi.org/10.3343/kjlm.2006.26.1.52

Evaluation of Indigenously Manufactured Immunochromatographic Assay Systems for Rapid Detection of Hepatitis B Surface Antigen and Antibody

Young Joo Cha, M.D., Joo Suk Yang, Seok Lae Chae, M.D.¹

Department of Laboratory Medicine, Chung-Ang University and Dong-Kook University, Seoul, Korea

¹Department of College of Medicine, Chung-Ang University and Dong-Kook University, Seoul, Korea

Received 25 August 2005 Revised 28 October 2005 Accepted 4 November 2005

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

We evaluated three indigenously produced immunochromatography (ICA) kits for the rapid detection of hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) by comparing them with a microparticle enzyme immunoassay (MEIA).

Methods

HBsAg and anti-HBs were tested by the ICA kits manufactured by three domestic companies, SD HBsAg and Anti-HBs (Standard Diagnostics, Inc., Yongin, Korea); Asan Easy Test^® HBsAg and Anti-HBs (Asan Pharm Co., Ltd., Whasung, Korea); and GENEDIA^® HBsAg Rapid Device and Anti-HBs Rapid Device (Green Cross MS, Inc., Yongin, Korea).

Results

Results by ICA agreed completely with those of MEIA in all the 20 HBsAg-negative sera and in all the anti-HBs-negative sera except one sample. Among the 20 HBsAg-positive sera by MEIA, 17 were positive by ICA using Green Cross MS, 16 using Asan Pharm Co., and 13 using SD and reverse passive hemagglutination. Among the 20 anti-HBs-positive sera by MEIA, 19 were positive by ICA using Green Cross MS and Asan Pharm Co., 17 using SD, and 18 by passive hemagglutination. Elapsed time for the control and test line to be visualized in ICA might be longer and the color of the lines lighter when using SD than Green Cross MS or Asan Pharm Co.

Conclusions

Three indigenously produced ICA kits are as sensitive as MEIA for the detection of anti-HBs, but are less sensitive than MEIA for HBsAg. The ICA kits for the rapid detection of HBsAg might be recommended for a limited use in the clinical laboratory.

Keywords: Immunochromatography (ICA), HBsAg, anti-HBs, MEIA, Rapid detection

References

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Table 1.

Comparison of the results of HBsAg assayed by immunochromatography (ICA) with those by microparticle enzyme immunoassay (MEIA) and reverse passive hemagglutination (RPHA)

	MEIA
	Negative (n=20) S/N<2.0	Positive (n=20) S/N≥2.0
ICA1 (SD)	20/20^* Negative	13/20^† Positive
ICA2 (Asan)	20/20 Negative	16/20 Positive
ICA3 (Green Cross)	20/20 Negative	17/20 Positive
RPHA (Asan)	20/20 Negative	13/20 Positive

^* Negative in 20 out of 20 samples,

^† Positive in 13 out of 20 samples.

Table 2.

Distribution of HBsAg results according to the S/N value measured by microparticle enzyme immunoassay (MEIA)

Sample No.	ICA1 (SD)	ICA2 (Asan)	ICA3 (Green Cross)	RPHA (Asan)	HBsAg S/N value
N1-N20	Neg	Neg	Neg	Neg	0.27–1.41
P1	Neg	Neg	Neg	Neg	6.25
P2	Neg	Neg	Neg	Neg	12.55
P3	Neg	Neg	Neg	Neg	23.66
P4	Neg	Neg	+	Neg	59.94
P5	Neg	+	+	Neg	81.25
P6	Neg	+	+	Neg	127.15
P7	Neg	+	+	Neg	129.58^*
P8	+	+	+	+	136.88^*
P9	+	+	+	+	157.82
P10	+	+	+	+	168.96^*
P11	+	+	+	+	171.25
P12	+	+	+	+	182.35
P13	+	+	+	+	195.45
P14	+	+	+	+	201.54
P15	+	+	+	+	245.58
P16	+	+	+	+	278.54
P17	+	+	+	+	301.25
P18	+	+	+	+	325.17
P19	+	+	+	+	336.87
P20	+	+	+	+	345.58

^* Samples diluted with negative serum.

N1-N20, Numbers for the HBsAg-negative samples by the MEIA; P1-P20, Numbers for the HBsAg-positive samples by the MEIA.

Abbreviations: ICA, immunochromatography; RPHA, reverse passive hemagglutination.

Table 3.

Comparison of the results of anti-HBs assayed by immunochromatography (ICA) with those by microparticle enzyme immunoassay (MEIA) and passive hemagglutination (PHA)

	Anti-HBs by MEIA
	Negative (n=20) <10 mIU/mL	Positive (n=20) ≥10 mIU/mL
ICA1 (SD)	20/20^* Negative	17/20^† Positive
ICA2 (Asan)	19/20 Negative	19/20 Positive
ICA3 (Green Cross)	19/20 Negative	19/20 Positive
PHA (Asan)	20/20 Negative	18/20 Positive

^* Negative in 20 out of 20 samples;

^† Positive in 17 out of 20 samples.

Table 4.

Distribution of anti-HBs results according to the antibody titer measured by microparticle enzyme immunoassay (MEIA)

Sample No.	ICA1 (SD)	ICA2 (Asan)	ICA3 (Green Cross)	PHA (Asan)	Anti-HBs Titer (mIU/mL)
N1-N19	Neg	Neg	Neg	Neg	0.0–9.5
N20	Neg	+	+	Neg	9.7
P1	Neg	+	+	Neg	10.1
P2	Neg	+	+	+	10.9
P3	Neg	Neg	Neg	Neg	14.1
P4	+	+	+	+	14.5
P5	+	+	+	+	15.1
P6	+	+	+	+	15.3
P7	+	+	+	+	15.7^*
P8	+	+	+	+	16.2
P9	+	+	+	+	16.8^*
P10	+	+	+	+	23.5^*
P11	+	+	+	+	29.8
P12	+	+	+	+	40.6
P13	+	+	+	+	45.5
P14	+	+	+	+	47.9
P15	+	+	+	+	59.9
P16	+	+	+	+	67.6
P17	+	+	+	+	88.6
P18	+	+	+	+	112.5
P19	+	+	+	+	158.5
P20	+	+	+	+	>1,000

^* Samples diluted with negative serum.

N1-N20, Numbers for the anti-HBs negative samples by the MEIA; P1-P20, Numbers for the anti-HBs positive samples by the MEIA.

Abbreviations: ICA, immunochromatography; PHA, passive hemagglutination.

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