乙型肝炎e抗原血清学检测的性能特征评价

StephenW

J Clin Virol. 2018 Oct 13;109:22-28. doi: 10.1016/j.jcv.2018.10.005. [Epub ahead of print]
Evaluation of performance characteristics of hepatitis B e antigen serologic assays.
Mixson-Hayden T1, Purdy MA1, Ganova-Raeva L1, McGovern D1, Forbi JC1, Kamili S2.
Author information

1
    Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA 30329 United States.
2
    Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, GA 30329 United States. Electronic address: [email protected].

Abstract
BACKGROUND:

Hepatitis B e antigen (HBeAg) is considered an indicator of high hepatitis B virus (HBV) replication. Performance characteristics of commercially available HBeAg assays have not been determined, thus it is unknown whether lack of HBeAg detection is because of test sensitivity or HBV basal core promoter and precore mutations.
OBJECTIVES:

We studied the correlation between HBeAg reactivity with HBV DNA levels in three commercially available HBeAg assays using 335 HBsAg and HBV DNA positive serum/plasma samples.
STUDY DESIGN:

Diagnostic sensitivity was determined by serial dilutions of a WHO HBeAg standard. The limit of HBeAg detection estimated through regression was 1 IU/mL (Centaur), 97 IU/mL (DiaSorin) and 129 IU/mL (Vitros). Of these 335 samples, enough sample volume remained in 253 samples for head-to-head comparison of the assays.
RESULTS:

81 (32%), 41 (16%) and 36 (14%) of the samples were HBeAg positive by the Centaur, DiaSorin and Vitros assays, respectively. Compared to the FDA-approved Centaur assay the specificity of the other two assays was 98%, while sensitivity was 47% for the DiaSorin assay and 41% for the Vitros assay. Significant association was found between HBeAg positive samples and HBV DNA levels >20,000 IU/mL; 31% of HBeAg negative samples (Centaur) had HBV DNA levels >20,000 IU/mL, 26% of HBeAg positive samples had HBV DNA levels <20,000 IU/mL and 5 HBeAg positive samples had HBV DNA levels <2000 IU/mL.
CONCLUSION:

Discordance was seen between these HBeAg assays, indicating reliance on HBeAg alone as a marker of high HBV replication can be misleading. Detection and quantification of HBV DNA remains the accurate and reliable marker of HBV replication.

Published by Elsevier B.V.
KEYWORDS:

Assay comparison; Genotype; HBV DNA; HBeAg; Hepatitis B virus; Precore/core mutants

PMID:
    30388663
DOI:
    10.1016/j.jcv.2018.10.005

StephenW

J Clin Virol。 2018年10月13日; 109：22-28。 doi：10.1016 / j.jcv.2018.10.005。 [提前打印]
乙型肝炎e抗原血清学检测的性能特征评价。
Mixson-Hayden T1，Purdy MA1，Ganova-Raeva L1，McGovern D1，Forbi JC1，Kamili S2。
作者信息

1
    病毒性肝炎分部，疾病控制和预防中心，亚特兰大，GA 30329美国。
2
    病毒性肝炎分部，疾病控制和预防中心，亚特兰大，GA 30329美国。电子地址：[email protected]。

抽象
背景：

乙型肝炎e抗原（HBeAg）被认为是高乙型肝炎病毒（HBV）复制的指标。市售HBeAg测定的性能特征尚未确定，因此尚不清楚HBeAg检测缺乏是由于测试敏感性还是HBV基础核心启动子和前核心突变。
目的：

我们使用335 HBsAg和HBV DNA阳性血清/血浆样品研究了三种商业上可获得的HBeAg测定中HBeAg反应性与HBV DNA水平之间的相关性。
学习规划：

通过WHO HBeAg标准的连续稀释来确定诊断灵敏度。通过回归估计的HBeAg检测限为1 IU / mL（Centaur），97 IU / mL（DiaSorin）和129 IU / mL（Vitros）。在这335个样品中，足够的样品体积保留在253个样品中，用于测定的头对头比较。
结果：

通过Centaur，DiaSorin和Vitros测定，81（32％），41（16％）和36（14％）样品分别为HBeAg阳性。与FDA批准的Centaur测定相比，其他两种测定的特异性为98％，而DiaSorin测定的灵敏度为47％，Vitros测定的灵敏度为41％。 HBeAg阳性样本与HBV DNA水平> 20,000 IU / mL之间存在显着相关性; 31％的HBeAg阴性样本（Centaur）的HBV DNA水平> 20,000 IU / mL，26％的HBeAg阳性样本的HBV DNA水平<20,000 IU / mL，5个HBeAg阳性样本的HBV DNA水平<2000 IU / mL。
结论：

在这些HBeAg测定之间观察到不一致，表明单独依赖HBeAg作为高HBV复制的标记可能会产生误导。 HBV DNA的检测和定量仍然是HBV复制的准确可靠标记。

由Elsevier B.V.出版
关键词：

分析比较;基因型; HBV DNA;大三阳;乙型肝炎病毒;前核/核心突变体

结论：
    30388663
DOI：
    10.1016 / j.jcv.2018.10.005