Assessing the Utility of Shortened Read Time of the Abbott Bioline HCV Test to Predict Viremia

IF 2.3 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Viral Hepatitis Pub Date : 2026-06-16 DOI:10.1111/jvh.70198

Bridget Louise Draper, Mon Mon Su Naing, Hla Htay, Mia Flynn, Mark Stoove, Margaret Hellard, Alisa Pedrana

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Abstract

The current two-step model for HCV diagnosis risks losing people from care; a one-step diagnostic approach could improve retention. We investigated whether shortening the read time of an HCV antibody test from 20-min to 1 or 5-min could accurately predict HCV RNA viremia in-lieu of a standard RNA test. 1110 people in Yangon had a HCV Ab using Bioline HCV RDT. Results were recorded at 1-min intervals until 20-min, with HCV RNA testing of reactive results at 20-min. 884 participants returned both antibody and RNA results; 838 were Ab reactive at 1-min, 875 were reactive at 5-min and 728 were RNA positive. Sensitivity was 98.6% and 100% for 1 and 5-min read-times, and specificity was 23.1% and 5.8% for 1 and 5-min respectively. Our results suggest that reading the Bioline at 5 min has potential to identify patients with HCV infection ahead of reflexive RNA testing.

Trial Registration: ClinicalTrials.gov:NCT03939013

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评估缩短阅读时间的雅培生物碱HCV检测预测病毒血症的效用。

目前丙型肝炎病毒诊断的两步模式有使患者失去治疗的风险；一步诊断方法可以提高保留率。我们研究了将HCV抗体检测的读取时间从20分钟缩短到1或5分钟是否可以代替标准RNA检测准确预测HCV RNA病毒血症。使用Bioline HCV RDT，仰光有1110人检测出HCV抗体。每隔1分钟至20分钟记录一次结果，20分钟检测HCV RNA反应性结果。884名参与者同时返回了抗体和RNA结果；838例1分钟抗体阳性，875例5分钟抗体阳性，728例RNA阳性。1和5 min的灵敏度分别为98.6%和100%，1和5 min的特异性分别为23.1%和5.8%。我们的研究结果表明，在5分钟时读取Bioline有可能在反射性RNA检测之前识别HCV感染患者。试验注册：ClinicalTrials.gov:NCT03939013。

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来源期刊

Journal of Viral Hepatitis 医学-病毒学

CiteScore

6.00

自引率

8.00%

发文量

138

审稿时长

1.5 months

期刊介绍： The Journal of Viral Hepatitis publishes reviews, original work (full papers) and short, rapid communications in the area of viral hepatitis. It solicits these articles from epidemiologists, clinicians, pathologists, virologists and specialists in transfusion medicine working in the field, thereby bringing together in a single journal the important issues in this expanding speciality. The Journal of Viral Hepatitis is a monthly journal, publishing reviews, original work (full papers) and short rapid communications in the area of viral hepatitis. It brings together in a single journal important issues in this rapidly expanding speciality including articles from: virologists; epidemiologists; clinicians; pathologists; specialists in transfusion medicine.