HBcrAg对无肝病或肝炎的慢性感染中1582 HBeAg阴性个体进行分类

StephenW

Incremental value of HBcrAg to classify 1582 HBeAg-negative individuals in chronic infection without liver disease or hepatitis
Maurizia R Brunetto  1 , Ivana Carey  2 , Benjamin Maasoumy  3 , Cristina Marcos-Fosch  4 , André Boonstra  5 , Gian Paolo Caviglia  6 , Alessandro Loglio  7 , Daniela Cavallone  1 , Caroline Scholtes  8 , Gabriele Ricco  1 , Antonina Smedile  6 , Mar Riveiro-Barciela  4 , Florian van Bömmel  9 , Annemiek van der Eijk  5 , Fabien Zoulim  8 , Thomas Berg  9 , Markus Cornberg  3 , Pietro Lampertico  7 , Kosh Agarwal  2 , Maria Buti  4
Affiliations
Affiliations

    1
    Pisa, Italy.
    2
    London, UK.
    3
    Hannover, Germany.
    4
    Barcelona, Spain.
    5
    Rotterdam, the Netherlands.
    6
    Turin, Italy.
    7
    Milan, Italy.
    8
    Lyon, France.
    9
    Leipzig, Germany.

    PMID: 33465257 DOI: 10.1111/apt.16258

Abstract

Background: An accurate, single-point differential diagnosis between HBeAg-negative infection (ENI) and chronic hepatitis B (CHB) is an unmet need.

Aims: To assess the diagnostic value of the new hepatitis B core-related antigen (HBcrAg) assay.

Methods: A retrospective anonymised data analysis was performed in a multicentre European (nine centres and six countries) cohort of 1582 consecutive HBsAg-positive/HBeAg-negative subjects classified according to EASL guidelines as: 550-CHB, 710-ENI and 322-GZ (grey-zone, HBV-DNA <20 000 IU/mL).

Results: Mean age was 44 (±13.2 y), 59% were men; HBV genotypes were 15% A, 2% B, 2% C, 45% D, 9% E, 1% F and 26% unknown. Median HBV-DNA serum levels were 2.2 (1.5-2.7), 3.5 (3.2-3.8) and 5.6 (4.8-6.6) logIU/mL in ENI, GZ and CHB, P < 0.0001. HBsAg serum levels (HBsAgsl) were comparable in CHB and GZ, but lower in ENI (2.9 [2.1-3.6] logIU/mL), P < 0.0001. HBcrAg serum levels (HBcrAgsl) were <3 logU/mL in 90.7% (644/710) ENI, 75.2% (242/322) GZ and 4.7% (26/550) CHB (P < 0.0001). Median HBcrAgsl were 4.8 (3.9-5.7), 2.5 (2.0-2.9) and 2.0 (2.0-2.5) logU/mL in CHB, GZ and ENI, (P < 0.0001). ROC-AUCs for HBcrAg and HBsAg were 0.968 (95% CI, 0.958-0.977) and 0.732 (95% CI, 0.704-0.760) respectively. The optimal HBcrAgsl cut-off to distinguish CHB from ENI was 3.14 logU/mL (95% CI, 3.02-3.25, 91% SE, 93% SP and 92.4% DA). HBcrAgsl were associated with HBV genotypes (P < 0.001, one-way ANOVA) but using genotype-specific cut-offs, HBcrAg DA remained unchanged with overlapping 95% CI.

Conclusion: The HBcrAg assay showed high diagnostic performance in the accurate single-point identification of patients with HBeAg-negative CHB, independently of HBV genotype. This should prompt future prospective studies to confirm its diagnostic role in clinical practice.

© 2021 John Wiley & Sons Ltd.

StephenW

HBcrAg对无肝病或肝炎的慢性感染中1582 HBeAg阴性个体进行分类的增值
Maurizia R Brunetto 1，Ivana Carey 2，Benjamin Maasoumy 3，Cristina Marcos-Fosch 4，AndréBoonstra 5，Gian Paolo Caviglia 6，Alessandro Loglio 7，Daniela Cavallone 1，Caroline Scholtes 8，Gabriele Ricco 1，Antonina Smedile 6，Mar Rive -Barciela 4，Florian vanBömmel9，Annemiek van der Eijk 5，Fabien Zoulim 8，Thomas Berg 9，Markus Cornberg 3，Pietro Lampertico 7，Kosh Agarwal 2，Maria Buti 4
隶属关系
隶属关系

    1个
    意大利比萨。
    2
    英国伦敦。
    3
    德国汉诺威。
    4
    西班牙巴塞罗那。
    5
    荷兰鹿特丹。
    6
    意大利都灵。
    7
    意大利米兰。
    8
    法国里昂。
    9
    德国莱比锡。

    PMID：33465257 DOI：10.1111 / apt.16258

抽象

背景：HBeAg阴性感染（ENI）与慢性乙型肝炎（CHB）之间的准确，单点鉴别诊断是未满足的需求。

目的：评估新的乙型肝炎核心相关抗原（HBcrAg）检测方法的诊断价值。

方法：在多中心欧洲（九个中心和六个国家）队列中，对1582名连续的HBsAg阳性/ HBeAg阴性受试者进行了回顾性匿名数据分析，根据EASL指南将其分为：550-CHB，710-ENI和322-GZ （灰色区，HBV-DNA <20000 IU / mL）。

结果：平均年龄为44岁（±13.2岁），男性为59％； HBV基因型分别为15％A，2％B，2％C，45％D，9％E，1％F和26％未知。 ENI，GZ和CHB中的HBV-DNA血清中位水平分别为2.2（1.5-2.7），3.5（3.2-3.8）和5.6（4.8-6.6）logIU / mL，P <0.0001。 HBsAg血清水平（HBsAgsl）在CHB和GZ中相当，但在ENI中较低（2.9 [2.1-3.6] logIU / mL），P <0.0001。 90.7％（644/710）ENI，75.2％（242/322）GZ和4.7％（26/550）CHB中的HBcrAg血清水平（HBcrAgsl）<3 logU / mL（P <0.0001）。在CHB，GZ和ENI中，HBcrAgs1的中位数分别为4.8（3.9-5.7），2.5（2.0-2.9）和2.0（2.0-2.5）logU / mL（P <0.0001）。 HBcrAg和HBsAg的ROC-AUC分别为0.968（95％CI，0.958-0.977）和0.732（95％CI，0.704-0.760）。区分CHB与ENI的最佳HBcrAgsl临界值是3.14 logU / mL（95％CI，3.02-3.25、91％SE，93％SP和92.4％DA）。 HBcrAgs1与HBV基因型相关（P <0.001，单向方差分析），但使用基因型特异的临界值，HBcrAg DA保持不变，重叠95％CI。

结论：HBcrAg测定法可独立于HBV基因型对HBeAg阴性CHB患者进行准确的单点鉴定，具有较高的诊断性能。这应该促使未来的前瞻性研究证实其在临床实践中的诊断作用。

©2021 John Wiley＆Sons Ltd.