乙型肝炎患者乙型肝炎核心相关抗原免疫测定的诊断和分析

StephenW

J Clin Virol. 2019 Mar 4;114:1-5. doi: 10.1016/j.jcv.2019.03.003. [Epub ahead of print]
Diagnostic and analytical performance of the hepatitis B core related antigen immunoassay in hepatitis B patients.
van Halewijn GJ1, Geurtsvankessel CH2, Klaasse J2, van Oord GW3, de Knegt RJ3, van Campenhout MJ3, Boonstra A3, van der Eijk AA4.
Author information

1
    Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, the Netherlands; Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
2
    Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
3
    Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, the Netherlands.
4
    Department of Viroscience, Erasmus MC, University Medical Center Rotterdam, the Netherlands. Electronic address: [email protected].

Abstract
BACKGROUND:

Novel serological markers for Hepatitis B virus (HBV) infection are needed for prognosis and guidance of therapy.
OBJECTIVE:

We evaluated the diagnostic performance of the Fujirebio Lumipulse G HBcrAg immunoassay on the Fujirebio LUMIPULSE G1200 analyzer.
STUDY DESIGN:

Analytical performance was examined using three HBeAg positive HBV samples. Diagnostic specificity was assessed using subpanels of 54 confirmed acute HAV, HCV, HEV, B19, CMV and EBV infections. Diagnostic sensitivity was investigated in well-defined HBV positive patient groups, both treated and untreated, including immunocompromised patients.
RESULTS:

The Lumipulse G HBcrAg immunoassay provided a linear measurement at a dilution between 1:100 and1:10,000. Six out of 54 samples showed non-specific reactivity in sera from acute CMV, EBV and HEV infections, of which 2 of them >3 log U/ml. The highest levels of HBcrAg were measured in HBeAg positive patients, in both treated and untreated as well as in immunocompromised patients. Untreated patients had relatively low serum HBcrAg levels in the inactive carrier phase, which increased upon progression into the HBeAg-negative hepatitis phase. Also, we showed that the applicability of HBcrAg to distinguish between patients with resolved HBV infection and false-positive reactivity to solitary anti-HBc is limited.
CONCLUSIONS:

Our study demonstrated significant differences in HBcrAg levels depending on HBeAg status, the clinical phase, as well as the treatment status. Specificity of the assay is good; only 2 out of 54 samples showed reactivity above 3 log U/ml. Before implementing the assay in clinical practice, additional research in larger patient cohorts should be carried out.

Copyright © 2019. Published by Elsevier B.V.
KEYWORDS:

Diagnostics; Hepatitis B core related antigen; Hepatitis B virus; Sensitivity and specificity; Serological marker

PMID:
    30852396
DOI:
    10.1016/j.jcv.2019.03.003

StephenW

J Clin Virol。 2019年3月4日; 114：1-5。 doi：10.1016 / j.jcv.2019.03.003。 [印刷前的电子版]
乙型肝炎患者乙型肝炎核心相关抗原免疫测定的诊断和分析性能。
van Halewijn GJ1，Geurtsvankessel CH2，Klaasse J2，van Oord GW3，de Knegt RJ3，van Campenhout MJ3，Boonstra A3，van der Eijk AA4。
作者信息

1
    荷兰鹿特丹大学医学中心Erasmus MC消化内科和肝病学系;病毒科学系，Erasmus MC，荷兰鹿特丹大学医学中心。
2
    病毒科学系，Erasmus MC，荷兰鹿特丹大学医学中心。
3
    荷兰鹿特丹大学医学中心Erasmus MC消化内科和肝病学系。
4
    病毒科学系，Erasmus MC，荷兰鹿特丹大学医学中心。电子地址：[email protected]。

抽象
背景：

乙型肝炎病毒（HBV）感染的新血清学标志物是预后和治疗指导所必需的。
目的：

我们在Fujirebio LUMIPULSE G1200分析仪上评估了Fujirebio Lumipulse G HBcrAg免疫测定的诊断性能。
学习规划：

使用三种HBeAg阳性HBV样品检查分析性能。使用54个确认的急性HAV，HCV，HEV，B19，CMV和EBV感染的子面板评估诊断特异性。在明确定义的HBV阳性患者组中进行了诊断敏感性研究，包括治疗和未治疗，包括免疫功能低下的患者。
结果：

Lumipulse G HBcrAg免疫测定提供了在1：100和1：10,000稀释度下的线性测量。 54个样本中的6个在急性CMV，EBV和HEV感染的血清中显示出非特异性反应性，其中2个> 3log U / ml。在HBeAg阳性患者中，在治疗和未治疗以及免疫功能低下的患者中测量最高水平的HBcrAg。未治疗的患者在无活性载体期具有相对低的血清HBcrAg水平，其在进展为HBeAg阴性肝炎期后增加。此外，我们发现HBcrAg用于区分已解决的HBV感染患者和对单独抗HBc的假阳性反应的适用性是有限的。
结论：

我们的研究表明HBcrAg水平的显着差异取决于HBeAg状态，临床阶段以及治疗状态。该试验的特异性良好; 54个样品中只有2个显示反应性高于3logU / ml。在临床实践中实施该测定之前，应该对更大的患者队列进行额外的研究。

版权所有©2019。Elsevier B.V.
关键词：

诊断;乙型肝炎核心相关抗原;乙型肝炎病毒;敏感性和特异性;血清学标志物

结论：
    30852396
DOI：
    10.1016 / j.jcv.2019.03.003