Comparative evaluation of four commercial analyzers for the serological screening of hepatitis A.

IF 4 3区医学 Q2 VIROLOGY

Virology Journal Pub Date : 2025-06-24 DOI:10.1186/s12985-025-02770-2

Junhyup Song, Jiyeon Kim, Sinyoung Kim, Younhee Park

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引用次数: 0

Abstract

Background: Serological assays for hepatitis A virus (HAV) play a crucial role in diagnosing acute infections and monitoring disease transmission. Given their widespread use in clinical laboratories, discrepancies among different immunoassay analyzers may have significant clinical implications. This study aimed to assess the quantitative and qualitative agreement between anti-HAV total immunoglobulin (or IgG) and IgM results across four fully automated immunoassay systems.

Methods: A total of 280 and 223 clinical serum samples were tested for anti-HAV total immunoglobulin (or IgG) and IgM, respectively, using four immunoanalyzers: Vitros ECiQ (Ortho), Atellica IM 1600 (Siemens), Alinity i (Abbott), and Cobas e801 (Roche). Quantitative correlations and qualitative agreements were assessed, and cases with discordant anti-HAV IgM results were further investigated using available clinical data.

Results: While the total immunoglobulin (or IgG) assay demonstrated a strong correlation across all platforms, substantial discrepancies were observed in the IgM results, particularly between the Vitros ECiQ and the other three analyzers. Although the other three platforms yielded concordant results, the clinical review indicated that in 4 out of 6 cases (66.6%), the Vitros ECiQ results aligned more closely with the clinical presentations.

Conclusions: This study highlights inter-assay variability in anti-HAV IgM detection and underscores the need for improved harmonization across platforms. Future studies incorporating a sufficient number of molecularly confirmed acute hepatitis A cases are warranted to clarify the causes of false results and minimize the potential clinical impact of inaccurate testing.

查看原文本刊更多论文

四种市售甲肝血清学筛查分析仪的比较评价。

背景：甲型肝炎病毒（HAV）的血清学检测在诊断急性感染和监测疾病传播方面发挥着至关重要的作用。鉴于它们在临床实验室的广泛使用，不同免疫分析分析仪之间的差异可能具有重要的临床意义。本研究旨在评估四种全自动免疫分析系统中抗甲型肝炎总免疫球蛋白（或IgG）和IgM结果的定量和定性一致性。方法：采用Vitros ECiQ （Ortho）、Atellica IM 1600（西门子）、Alinity i（雅培）和Cobas e801（罗氏）4种免疫分析仪，分别检测280份和223份临床血清抗甲型肝炎总免疫球蛋白（IgG）和IgM。评估定量相关性和定性一致性，并利用现有临床资料进一步调查抗hav IgM结果不一致的病例。结果：虽然总免疫球蛋白（或IgG）测定在所有平台上显示出很强的相关性，但在IgM结果中观察到实质性差异，特别是在Vitros ECiQ和其他三种分析仪之间。尽管其他三个平台产生了一致的结果，但临床评价表明，在6例中有4例（66.6%），Vitros ECiQ结果与临床表现更接近。结论：本研究强调了抗甲型肝炎IgM检测的不同检测方法之间的差异，并强调了在不同平台间改进统一检测方法的必要性。未来的研究将纳入足够数量的分子证实的急性甲型肝炎病例，以澄清错误结果的原因，并最大限度地减少不准确检测的潜在临床影响。

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

Virology Journal 医学-病毒学

CiteScore

7.40

自引率

2.10%

发文量

186

审稿时长

1 months

期刊介绍： Virology Journal is an open access, peer reviewed journal that considers articles on all aspects of virology, including research on the viruses of animals, plants and microbes. The journal welcomes basic research as well as pre-clinical and clinical studies of novel diagnostic tools, vaccines and anti-viral therapies. The Editorial policy of Virology Journal is to publish all research which is assessed by peer reviewers to be a coherent and sound addition to the scientific literature, and puts less emphasis on interest levels or perceived impact.