Enhanced Diagnostic Accuracy in Hepatitis B: Human vs. Sheep-Derived Antibodies in HBsAg Confirmatory Testing.

IF 0.7 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY

Clinical laboratory Pub Date : 2024-11-01 DOI:10.7754/Clin.Lab.2024.240527

Seunghwan Kim, Min-Kyung So, Tae-Dong Jeong, Soo-Kyung Kim

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引用次数: 0

Abstract

Background: HBsAg confirmatory testing is crucial for accurately diagnosing HBV infection and avoiding false positives. We compared the performance of human-derived and sheep-derived anti-HBs reagents in the Elecsys HBsAg confirmatory test (Roche Diagnostics, Germany).

Methods: Samples with a HBsAg COI of 0.9 or more underwent confirmatory testing with both reagents. Results showed a high overall agreement rate of 98% between human and sheep reagents.

Results: The average confirmation percentage with sheep anti-HBs was significantly lower than with human anti-HBs (6.9% vs. 20.0%, p = 0.002). Additionally, some strongly positive HBsAg samples could not be neutralized.

Conclusions: This suggests that the polyclonal antibodies in these reagents have different specificities and affinities for HBsAg epitopes. The findings emphasize the importance of reagent specificity and affinity to ensure accurate HBV diagnosis. Additional HBV markers and clinical context must be considered to confirm the diagnosis.

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提高乙型肝炎的诊断准确性：HBsAg 确证测试中人与绵羊衍生抗体的对比。

背景：HBsAg 确诊试验对于准确诊断 HBV 感染和避免假阳性至关重要。我们比较了人源抗 HBs 试剂和羊源抗 HBs 试剂在 Elecsys HBsAg 确证检验（德国罗氏诊断公司）中的性能：方法：对 HBsAg COI 为 0.9 或以上的样本使用两种试剂进行确证检测。结果显示，人和羊试剂的总体一致率高达 98%：结果：羊抗 HBs 的平均确认率明显低于人抗 HBs（6.9% 对 20.0%，P = 0.002）。此外，一些 HBsAg 强阳性样本无法被中和：结论：这表明这些试剂中的多克隆抗体对 HBsAg 表位具有不同的特异性和亲和力。这些发现强调了试剂特异性和亲和力对确保准确诊断 HBV 的重要性。确诊时还必须考虑其他 HBV 标志物和临床背景。

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

Clinical laboratory 医学-医学实验技术

CiteScore

1.50

自引率

0.00%

发文量

494

审稿时长

3 months

期刊介绍： Clinical Laboratory is an international fully peer-reviewed journal covering all aspects of laboratory medicine and transfusion medicine. In addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies. The journal publishes original articles, review articles, posters, short reports, case studies and letters to the editor dealing with 1) the scientific background, implementation and diagnostic significance of laboratory methods employed in hospitals, blood banks and physicians'' offices and with 2) scientific, administrative and clinical aspects of transfusion medicine and 3) in addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies.