DxI 9000接入免疫分析分析仪上抗- hbc IgM检测的性能评价

IF 2.1 4区医学 Q3 INFECTIOUS DISEASES

Diagnostic microbiology and infectious disease Pub Date : 2025-04-17 DOI:10.1016/j.diagmicrobio.2025.116862

Catherine Coignard , Claire Vincent , Veronique Lemée , Jean-Christophe Plantier , Jérémie Gautier , Françoise Leboulaire , Marc Turini , Gaiane Demirdjian , Magali Karagueuzian , Vanessa Roulet , Juliane Hey , Dan W. Rhodes

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引用次数: 0

摘要

本研究评估了用于DxI 9000 Access免疫分析分析仪的Access抗hbc IgM检测（Access assay）的诊断和分析性能。前瞻性和回顾性收集的样本使用Access和比较物测定法进行测试，并使用第二比较物进行差异分辨，以确定最终的抗hbc IgM样本状态。对1098例抗hbc IgM阴性献血者样本的特异性为100.00%(99.65 ~ 100.00%)，对300例抗hbc IgM阴性住院患者样本的特异性为100.00%(98.74 ~ 100.00%)，对169例抗hbc IgM阴性急性/近期和慢性HBV感染患者样本的特异性为94.08%（89.45 ~ 96.75%）。239例抗hbc IgM阳性急性/近期和慢性HBV感染患者样本的敏感性为100.00%（98.42 ~ 100.00%）。血清转换面板显示，使用Access的平均第一天检测时间比使用比较试剂的平均第一天检测时间早3.2天。阳性样品的最大重现性为方差系数（CV） 8.6%，阴性样品的最大重现性为标准差（SD） 0.048 S/CO。Access抗hbc IgM检测显示出与其他当前ce标记的抗hbc IgM检测相当的出色诊断和分析性能。

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Performance evaluation of the access anti-HBc IgM Assay on the DxI 9000 access immunoassay analyzer

This study evaluated the diagnostic and analytical performances of the Access anti-HBc IgM assay (Access assay) for use on the DxI 9000 Access Immunoassay Analyzer. Prospectively and retrospectively collected samples were tested with Access and a comparator assay with use of a second comparator for discrepant resolution to determine final anti-HBc IgM sample status. Specificity of Access was 100.00 % (99.65 – 100.00 %) on 1,098 anti-HBc IgM negative blood donor samples, 100.00 % (98.74 – 100.00 %) on 300 anti-HBc IgM negative hospitalized patient samples and 94.08 % (89.45 – 96.75 %) on 169 anti-HBc IgM negative acute/recent and chronic HBV infected patient samples. Sensitivity was 100.00 % (98.42 – 100.00 %) on 239 anti-HBc IgM positive acute/recent and chronic HBV infected patient samples. Seroconversion panels showed mean first day of detection 3.2 days earlier with Access than with the comparator assay. Maximum reproducibility on positive samples was 8.6 % coefficient of variance (CV) and 0.048 S/CO standard deviation (SD) on negative samples.

The Access anti-HBc IgM assay demonstrated excellent diagnostic and analytical performances comparable to other current CE-marked anti-HBc IgM assays.

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来源期刊

Diagnostic microbiology and infectious disease 医学-传染病学

CiteScore

5.30

自引率

3.40%

发文量

149

审稿时长

56 days

期刊介绍： Diagnostic Microbiology and Infectious Disease keeps you informed of the latest developments in clinical microbiology and the diagnosis and treatment of infectious diseases. Packed with rigorously peer-reviewed articles and studies in bacteriology, immunology, immunoserology, infectious diseases, mycology, parasitology, and virology, the journal examines new procedures, unusual cases, controversial issues, and important new literature. Diagnostic Microbiology and Infectious Disease distinguished independent editorial board, consisting of experts from many medical specialties, ensures you extensive and authoritative coverage.