Performance Evaluation of 3 Kinds of HBsAg Qualitative Assays and 2 Kinds of Quantitative Assays

Jae-Sun Park; Jung-In Choi; Ji-Hun Lim; Joseph Jung; Seon-Ho Lee; Neung Hwa Park; Jung Woo Shin; Yang Won Nah; Chang Woo Nam; Young Joo Cha; Sung-Ryul Kim

doi:10.3343/lmo.2013.3.3.160

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Park, Choi, Lim, Jung, Lee, Park, Shin, Nah, Nam, Cha, and Kim: Performance Evaluation of 3 Kinds of HBsAg Qualitative Assays and 2 Kinds of Quantitative Assays

Original Article

Diagnostic Immunology

Laboratory Medicine Online 2013; 3(3): 160-168.

Published online: 1 July 2013

DOI: https://doi.org/10.3343/lmo.2013.3.3.160

Performance Evaluation of 3 Kinds of HBsAg Qualitative Assays and 2 Kinds of Quantitative Assays

Jae-Sun Park, M.D.¹, Jung-In Choi, M.D.¹, Ji-Hun Lim, M.D.¹, Joseph Jung, M.D.¹, Seon-Ho Lee, M.D.¹, Neung Hwa Park, M.D.², Jung Woo Shin, M.D.², Yang Won Nah, M.D.³, Chang Woo Nam, M.D.³, Young Joo Cha, M.D.⁴, Sung-Ryul Kim, M.D.¹

¹Department of Laboratory Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.

²Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.

³Department of General Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.

⁴Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

Corresponding author: Sung-Ryul Kim M.D. Department of Laboratory Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, 877 Bangeojinsunhwan-daro, Dong-gu, Ulsan 682-714, Korea. Tel: +82-52-250-7271, FAX: +82-52-250-8269, srkimuuh@hitel.net

Received 8 May 2012 Revised 22 August 2012 Accepted 27 August 2012

(open-access):

This is anOpen 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

Currently used techniques for quantitation of HBsAg often yield discordant results; therefore, development of quantitation techniques that can detect HBsAg with high accuracy has become very important. Recent advances have led to the development of several HBsAg detection systems. Here, we evaluated the performance of 3 newly developed detection systems, which can detect HBsAg both qualitatively and quantitavely, and determined the concordance among their results.

Methods

Four hundred and thirty two samples assigned to 4 groups-patient group, dilution group, weakly reactive group, and linearity group- were subjected to qualitative and quantitative detection of HBsAg by using the 3 systems developed by 3 major manufacturers; Abbott Architect, Roche E170 and Siemens Centaur XP.

Results

The results for the qualitative analyses were closely concordant among the three systems (98.3%) for all 432 samples. In 123 samples that were determined as HBsAg-negative, E170 (76%) distributed frequently at the upper half level (0.5-1.0) of negative reference range, compared with Architect (11%) and Centaur XP (22%). In particular, in 65 samples that were diluted from the strongly positive samples to obtain weakly positive samples, the average index values obtained using Architect (3.6 S/CO), E170 (4.2 COI) and Centaur XP (11.4 index value) differed significantly (P<0.0001). In the antiviral treatment group and the post-liver transplantation group, no inconsistency was observed among the results of the qualitative and quantitative assays. In the 18-fold serially diluted samples, no linearity was observed.

Conclusions

Because of the possibility of false-positive detection in the HBsAg-negative samples, regular management of equipment and appropriate selection of reagents are very important. In weakly positive samples, quantitative assay has not to be replaced for qualitative assay. Therefore, the qualitative assays should be used for screening the samples, whereas the quantitative assays should be used for monitoring the Hepatitis B virus (HBV) load in the samples determined as HBsAg-positive. The qualitative index value should not be interpreted as a quantitative measure of HBV load.

Keywords: Hepatitis B virus, HBsAg, Qualitative assay, Quantitative assay, Chemiluminescence immunoassay, Microparticle enzyme immunoassay, Electrochemiluminescence immunoassay

Figures and Tables

Fig. 1

Distribution of HBsAg qualitative results in 71 weakly positive group.

Fig. 2

Linearity test with serial dilution of 2 HBsAg strongly positive samples.

Fig. 3

Correlation between HBsAg qualitative and quantitative test using serially diluted samples.

Table 1

Characteristics of 3 automated HBsAg assays

^*Result between 0.9-1.0 was interpreted as borderline.

Abbreviations: Mo, monoclonal antibody; Po, polyclonal antibody; CMIA, chemiluminescence microparticle immunoassay; ECLIA, electrochemiluminescence immunoassay; CLIA, chemiluminescence immunoassay.

Table 2

The result of HBsAg qualitative test in 432 samples

^*Five samples were insufficient in volume to be tested.

Definition: Weak positive, 1.0 S/CO≤HBsAg<10.0 S/CO; Strong positive, HBsAg≥10.0 S/CO.

Table 3

The result of HBsAg qualitative test in negative samples

^*Five samples were insufficient in volume to be tested.

Table 4

Comparison of HBsAg qualitative test in different sample groups

^*Three samples were insufficient in volume to be tested in negative group, Two samples were insufficient in volume to be tested in post LT group.

Definition and abbreviations: Weak positive, 1.0 S/CO≤HBsAg<10.0 S/CO; Strong positive, HBsAg≥10.0 S/CO; HSB20111214, Human serum bank samples; CHB with Tx., chronic hepatitis B with antiviral treatment; LT, liver transplantation.

Table 5

Comparison of HBsAg quantitative test results between Architect and E170 in different sample groups

^*One sample was insufficient in volume to be tested in negative group; ^†One sample was insufficient in volume to be tested in post LT group.

Table 6

Discrepant results between HBsAg qualitative and quantitative tests in 71 weakly positive samples

Abbreviations: N, Negative; P, Positive.

Table 7

Comparison of HBsAg qualitative test in 135 samples diluted to be weakly positive

Definition: Weak positive, 1.0 S/CO≤HBsAg<10.0 S/CO; Strong positive, HBsAg≥10.0 S/CO.

Table 8

Discrepant results in HBsAg qualitative test with samples diluted to be weakly positive samples among 3 different assays

^*BL, Borderline; WP, Weak Positive, 1.0 S/CO≤HBsAg<10.0 S/CO; SP, Strong positive, HBsAg≥10.0 S/CO.

Abbreviations: S/CO, sample cutoff value; COI, Cutoff index.

Table 9

Discrepant results of HBsAg qualitative and quantitative tests with samples diluted to be weakly positive

Weakly Positive: 1.0 S/CO≤HBsAg<10.0 S/CO.

Abbreviations: N, Negative; P, Positive.

Notes

This article is available from http://www.labmedonline.org

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