HIV患者丙型肝炎病毒抗体确认试验的比较。

IF 1.7 4区 医学 Q3 INFECTIOUS DISEASES
Sexually transmitted diseases Pub Date : 2025-11-01 Epub Date: 2025-06-16 DOI:10.1097/OLQ.0000000000002205
Fien Vanroye, Kimcheng Choun, Els Genbrugge, Koen Vercauteren, Dorien Van den Bossche
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引用次数: 0

摘要

背景:世卫组织建议检测受丙肝病毒感染影响最严重的人群,如艾滋病毒感染者(PLWH)。在进行Ab测试筛查后,需要进行HCV RNA测试以确定活动性(病毒)感染。可以通过实施HCV血清学确认试验,将HCV RNA检测能力集中在真阳性血清学检测结果上。我们的目的是评估三种HCV确认检测在PLWH中的表现。方法:收集于柬埔寨(西哈努克医院中心of HOPE)和比利时(热带医学研究所)的415份冷冻血浆标本,采用genenius HCV补充检测(Bio-Rad)、HCV Blot 3.0 (MP Biomedical, California)和INNO-LIA HCV Score (Fujirebio, Belgium)进行检测。将结果与HCV RNA结果和/或复合参考标准进行比较。结果:总体而言,innol - lia具有最高的灵敏度(97.0%;95% CI: 94.0%-98.5%), genenius特异性最高(98.2%;95% ci: 93.7%-99.5%)。在一组活动性感染患者(n = 177)中,所有三种检测方法均显示出相当的敏感性(99.0%,95% CI: 96.0 - 100.0%)。innol - lia均为8.7%;36/415)和HCV Blot (7.0%;29/415)的不确定结果多为阴性和/或不确定(分别为80.6%(29/36)和93.1%(27/29),而genius的不确定结果仅为26.3%(10/38)。结论:所有三种Ab确认试验在活动性HCV感染中显示出相当高的敏感性。genius可能在易用性、低周转时间和排除过去感染方面具有一些优势。丙型肝炎病毒抗体确认检测的附加价值需要在更大规模的成本效益研究中确定,并受到丙型肝炎病毒患病率和丙型肝炎病毒RNA容量下降的影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparison of Antibody Confirmation Assays for Hepatitis C Virus Testing in Patients With HIV.

Background: The World Health Organisation recommends testing populations most affected by hepatitis C virus (HCV) infection, like people living with HIV. After screening with an Ab test, HCV RNA testing is required to identify active (viremic) infections. One could focus the HCV RNA testing capacity on true positive serological test results, by implementing serological HCV confirmation assays. Our goal was to evaluate the performance of 3 HCV confirmation assays in people living with HIV.

Methods: A total of 415 frozen plasma specimens collected in Cambodia (Sihanouk Hospital Center of HOPE) and Belgium (Institute of Tropical Medicine) were tested with Geenius HCV supplemental Assay (Bio-Rad, Marne la Coquette, France), HCV Blot 3.0 (MP Biomedical, Irvine, CA), and INNO-LIA HCV Score (Fujirebio, Ghent, Belgium). Results were compared against HCV RNA results and/or a composite reference standard.

Results: Overall, INNO-LIA had the highest sensitivity (97.0%; 95% confidence interval [CI], 94.0%-98.5%) and Geenius the highest specificity (98.2%; 95% CI, 93.7%-99.5%). In a subset of patients with active infection (n = 177), all 3 assays showed comparable sensitivity (99.0%; 95% CI, 96.0%-100.0%). Both for INNO-LIA (8.7% [36 of 415]) and HCV Blot (7.0% [29 of 415]), the indeterminate results were mostly negative and/or indeterminate (80.6% [29 of 36] and 93.1% [27 of 29], respectively) on the composite reference standard compared with only 26.3% (10 of 38) on Geenius.

Conclusions: All 3 antibody confirmation assays show comparable and high sensitivity in active HCV infections. Geenius potentially offers some advantages in ease of use, low turnaround time, and ruling out past infections. The added value of HCV antibody confirmation assays needs to be established in larger cost-effectiveness studies and is influenced by decreasing HCV prevalence and HCV RNA capacity.

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来源期刊
Sexually transmitted diseases
Sexually transmitted diseases 医学-传染病学
CiteScore
4.00
自引率
16.10%
发文量
289
审稿时长
3-8 weeks
期刊介绍: ​Sexually Transmitted Diseases, the official journal of the American Sexually Transmitted Diseases Association​, publishes peer-reviewed, original articles on clinical, laboratory, immunologic, epidemiologic, behavioral, public health, and historical topics pertaining to sexually transmitted diseases and related fields. Reports from the CDC and NIH provide up-to-the-minute information. A highly respected editorial board is composed of prominent scientists who are leaders in this rapidly changing field. Included in each issue are studies and developments from around the world.
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