Does the ultrasensitive HBsAg Next assay enhance Hepatitis B diagnosis? An evaluation of analytical performances

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-06-22 DOI:10.1016/j.jcv.2024.105707

Joachim Bourdin , Pierre Sellier , Maud Salmona , Caroline Lascoux-Combe , Constance Delaugerre , Sarah Maylin

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引用次数: 0

Abstract

Background

Accurate laboratory confirmation for Hepatitis B diagnosis and monitoring are crucial. Recently an ultrasensitive immunoassay test, the HBsAg Next (HBsAgNx), has been reported approximately eight times more sensitive than current HBsAg assays. The aim of our study was to assess the analytical performances of this new test.

Methodology

253 clinical samples from Saint Louis University Hospital were analyzed, splitted into four panels: (1) routine prospectively screening serums (n = 196), (2) retrospective serum samples before HBV reactivation (HBV-R) (n = 18), (3) occult HBV infection (OBI) (n = 10) and (4) a selection of wild type HBV genotypes (n = 29)

Results

Panel 1, showed robust agreement with the HBsAg Qualitative II (HBsAgQII) assay (Cohen's kappa = 0.83). Despite this agreement, 7 false positive with the HBsAgQII assay were found negative with HBsAgNx. One OBI was detected only with HBsAgNx. Panel 2 showed potential time savings in diagnosing HBV-R using HBsAgNx among 4/18 HBsAg positives samples. Panel 3 highlighted the ability of HBsAgNx to detect HBsAg in OBI patients defined by negative for HBsAg with HBsAgQII assay and positive for HBV DNA. Furthermore, the HBsAgNx assay detected all different genotypes.

Conclusion

The study highlights the effectiveness of the HBsAgNx assay, showing its performance. It excels in detecting weakly positive samples and addressing challenging cases. HBsAgNx assay demonstrates promising analytical performances, with improved sensitivity and specificity compared to standard HBsAgQII assay, able to detect all genotypes. Its potential impact on early detecting and monitoring reactivations, and occult infections could be very useful in clinical practice.

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超灵敏 HBsAg Next 检测法是否能提高乙型肝炎诊断水平？分析性能评估。

背景：准确的实验室确认对乙肝诊断和监测至关重要。最近有报道称，一种超灵敏的免疫测定方法--HBsAg Next（HBsAgNx）的灵敏度比目前的 HBsAg 检测方法高出约八倍。我们的研究旨在评估这种新检测方法的分析性能。方法：我们对圣路易斯大学医院的 253 份临床样本进行了分析，这些样本分为四组：(结果：第 1 组样本与 HBsAg Qualitative II (HBsAgQII) 检测方法的一致性很好（Cohen's kappa = 0.83），第 2 组样本与 HBsAg Qualitative II (HBsAgQII) 检测方法的一致性很好（Cohen's kappa = 0.83），第 3 组样本与 HBsAg Qualitative II (HBsAgQII) 检测方法的一致性很好（Cohen's kappa = 0.83).尽管结果一致，但在 HBsAgNx 检测中发现有 7 例 HBsAgQII 检测假阳性结果为阴性。只有 HBsAgNx 检测出了一个 OBI。图 2 显示，在 4/18 份 HBsAg 阳性样本中，使用 HBsAgNx 诊断 HBV-R 可节省时间。面板 3 强调了 HBsAgNx 检测 OBI 患者 HBsAg 的能力，OBI 的定义是 HBsAgQII 检测中 HBsAg 阴性但 HBV DNA 阳性。此外，HBsAgNx 检测法还能检测出所有不同的基因型：结论：这项研究强调了 HBsAgNx 检测法的有效性，显示了它的性能。它在检测弱阳性样本和处理疑难病例方面表现出色。与标准 HBsAgQII 检测法相比，HBsAgNx 检测法的灵敏度和特异性都有所提高，能够检测出所有基因型，显示出良好的分析性能。它对早期检测和监测再激活和隐性感染的潜在影响在临床实践中可能非常有用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)