三种发光免疫测定乙型肝炎病毒表面抗原定量的慢性乙型肝

StephenW

Comparison of Three Luminescent Immunoassays for Hepatitis B Virus Surface Antigen Quantification during the Natural History of Chronic Hepatitis B Virus Infection

    Xiao-Dong Cheng a,
    Liu-Wei Song b,
    Lin-Lin Fang b,
    Lin Yang b,
    Yong Wu b,
    Sheng-Xiang Ge b,
    Quan Yuan b,
    Jun Zhang b,
    Ning-Shao Xia b and
    Xiao-Ke Hao a

    aCenter of Clinical Laboratory Medicine of PLA, Xijing Hospital, Fourth Military Medical University, Xi'an, China
    bState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, China

    R. L. Hodinka, Editor

- Author Affiliations
ABSTRACT

Hepatitis B surface antigen (HBsAg) quantification has garnered attention because of its high predictive value in determining treatment responses. The HBsAg quantification assays, such as Architect and Elecsys, are commercially available, and more assays are in development. We aimed to compare the results of the Architect and Elecsys assays with those of a new assay, WTultra. The WTultra HBsAg assay is a sandwich chemiluminescent microplate enzyme immunoassay and provides an alternative choice which is more cost-effective and potentially applicable in developing or resource-constrained countries and areas. A total of 411 serum samples were collected from patients during various phases of chronic hepatitis B (CHB) infection. The samples were assessed using the three assays, and the results were compared and analyzed. The results for the Architect, Elecsys, and WTultra assays were well correlated according to the overall results for the samples (correlation coefficients, rArchitect versus WTultra = 0.936, rArchitect versus Elecsys = 0.952, and rWTultra versus Elecsys = 0.981) and the various infection phases (rArchitect versus WTultra ranging from 0.67 to 0.975, rArchitect versus Elecsys ranging from 0.695 to 0.982, and rWTultra versus Elecsys ranging from 0.877 to 0.99). Additionally, consistent results were observed according to genotype (genotype B: rArchitect versus WTultra = 0.976, rArchitect versus Elecsys = 0.978, and rWTultra versus Elecsys = 0.979; genotype C: rArchitect versus WTultra = 0.950, rArchitect versus Elecsys = 0.963, and rWTultra versus Elecsys = 0.981) and hepatitis B virus (HBV) DNA levels (rArchitect = 0.540, rWTultra = 0.553, and rElecsys = 0.580). In conclusion, the Elecsys and WTultra assays were well correlated with the Architect assay, irrespective of the CHB infection phase or genotype. All of these assays are reliable for HBsAg quantification.
FOOTNOTES

        Received 5 August 2014.
        Returned for modification 16 August 2014.
        Accepted 3 September 2014.
    Address correspondence to Quan Yuan, [email protected], or Xiao-Ke Hao, [email protected].

    X.-D.C. and L.-W.S. contributed equally to this article.

StephenW

三种发光免疫测定乙型肝炎病毒表面抗原定量的慢性乙型肝炎病毒感染的自然史中的比较

    萧董成一个，
    刘炜歌曲B，
    林遴砝嗯B，
    林阳B，
    雍巫B，
    胜项各B，
    袁泉B，
    张军B，
    宁邵西阿b和
    晓柯浩一

    临床检验医学解放军，西京医院，第四军医大学，西安，中国的aCenter
    分子疫苗学和分子诊断，诊断研究所和疫苗开发中的传染病，公共卫生学院，厦门大学，厦门，中国bState重点实验室

    R. L. Hodinka，编辑器

- 作者机构
摘要

乙型肝炎表面抗原（HBsAg）定量已经获得，因为在确定治疗响应它的高预测值的注意。的HBsAg的定量测定法，如建筑师和Elecsys测定，是市售的，并且多种测定正在开发中。我们的目的是建筑师的结果和的Elecsys分析与这些新的测定法中，WTultra的比较。该WTultra乙肝表面抗原测定是夹心化学发光微孔板酶免疫分析，并提供了另一种选择，这是更具成本效益和潜在的适用于发展中国家或资源有限的国家和地区。共411血清样本的患者在慢性乙型肝炎（CHB）感染的各个阶段收集。该样品用三个试验评估，并对结果进行比较和分析。其结果为建筑师，Elecsys测定，并WTultra测定法以及根据总体结果为样本的相关性（相关系数，rArchitect与WTultra=0.936，rArchitect相对的Elecsys=0.952，和rWTultra相对的Elecsys=0.981）和各种感染相（rArchitect与WTultra范围从0.67到0.975，rArchitect与Elecsys测定范围为0.695至0.982，而rWTultra与Elecsys测定范围为0.877〜0.99）。此外，一致的结果是根据观察到的基因型（基因型B：rArchitect与WTultra=0.976，rArchitect对比的Elecsys=0.978，而rWTultra对的Elecsys=0.979; C型：rArchitect与WTultra=0.950，rArchitect对比的Elecsys=0.963，而与rWTultra的Elecsys=0.981）和乙型肝炎病毒（HBV）DNA水平（rArchitect=0.540，rWTultra=0.553，和rElecsys=0.580）。总之，Elecsys测定和WTultra测定法以及相关的建筑师法，无论慢性乙肝感染期或基因型。所有这些测定是可靠的HBsAg的定量。
脚注

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        接受2014年9月3日。
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    十，直流和L-W.S.同等贡献这篇文章。