J Lab Med Qual Assur 2014; 36(4): 196-204
Published online December 31, 2014
Copyright © Korean Association of External Quality Assessment Service.
Ji Yeon Sohn1,2,*, Eun- Jee Oh3, Hyon-Suk Kim4, Hyung-Doo Park2, and Eun-Suk Kang2
1Department of Laboratory Medicine, National Cancer Center, Goyang; 2Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine; 3Department of Laboratory Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea College of Medicine; 4Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
*Previously affiliated with the institution
Correspondence to:Eun-Suk Kang
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea
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.
Background: The Elecsys hepatitis B surface antigen (HBsAg) II quantitative assay is a newly introduced electrochemiluminescence immunoassay incorporating an initial 1:400 onboard dilution and a simple algorithm to determine HBsAg levels in serum. We evaluated the performance of the Elecsys HBsAg II assay and determined the impact of its initial onboard dilution on laboratory efficiency. Methods: HBsAg levels were determined using both Roche Elecsys and Abbott Architect HBsAg assays. Linearity and precision of the Elecsys HBsAg II assay and its correlation with the Architect HBsAg assay were evaluated. In particular, precision was verified at Samsung Medical Center, Severance Hospital, Seoul St. Mary's Hospital in Seoul, using the same pooled serum controls. The efficiency of the dilution algorithm for both methods was verified using data from 1,848 clinical samples. Results: The Elecsys HBsAg II assay showed a good linearity from 0.1 to 48,000.0 IU/mL and a good correlation (r=0.9998) between expected and measured values. Precision analyses performed at Samsung Medical Center, Severance Hospital, Seoul St. Mary's Hospital showed excellent performance with coefficients of variation between 1.28% and 6.82%. The values of the Elecsys HBsAg II and Architect HBsAg assays were well correlated (n=506, r=0.987, P ＜0.001) and also reliably determined in hepatitis C virus- and hepatitis B virus-co-infected patient sera (n=27). In terms of efficiency, 64.0% of samples provided a final HBsAg result on the first run without the need for further dilution, when using the 1:400 onboard predilution protocol of the Elecsys HBsAg II assay. Conclusions: Given the excellent precision and correlation with the Architect assay, the Elecsys HBsAg II assay showed a potential advantage for laboratory efficiency by significantly reducing the need for retesting samples with high HBsAg levels. (J Lab Med Qual Assur 2014;36:196-204)
Keywords: Hepatitis B surface antigens, Elecsys HBsAg II, Architect HBsAg, Hepatitis B virus, Chronic hepatitis B
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