临床试验/NCT06508996

NCT06508996已完成不适用

Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System

Cepheid1 个研究点分布在 1 个国家目标入组 1,012 人开始时间: 2024年2月6日最近更新: 2024年7月19日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cepheid
入组人数: 1,012
试验地点: 1
主要终点: Percent Agreement compared to Patient infected status (PIS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.

详细描述

Whole blood specimens were collected from consented individuals with signs and symptoms and/or individuals at-risk of HCV infection, irrespective of HCV antibody status at a single timepoint.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Participant was ≥18 years old
•Participant was not on treatment at time of enrollment based on review of medical records or self-reported
•Participant had signs and symptoms and/or is considered at-risk of HCV infection

排除标准

•Clinician assessed that the participant was not suitable for inclusion

结局指标

主要结局

Percent Agreement compared to Patient infected status (PIS)

时间窗: 1 day

Clinical performance comparing Xpert test to PIS (NAAT + Antibody status)

次要结局

未报告次要终点

研究者

发起方

Cepheid

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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