A Prospective Study for the Collection of Whole Blood Samples to Support the Development and Validation of In Vitro Diagnostic Tests for Dengue

Abbott Rapid Dx0 个研究点目标入组 200 人开始时间: 2025年10月1日最近更新: 2025年10月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 200
主要终点: sample collection only, no specific outcome needed

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.

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: 12 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age ≥12-years-old
•Individuals suspected or confirmed for active dengue, with dengue-consistent symptoms onset up to and including 10 days before enrolment in this trial.

排除标准

•Subject has been vaccinated for dengue.
•Subject participates in an investigative drug, vaccine or medical device clinical study
•Participant is deemed unfit for the study by the Investigator
•Participant is unwilling or unable to provide informed consent

结局指标

主要结局

sample collection only, no specific outcome needed

时间窗: 5 months

次要结局

未报告次要终点

研究者

发起方

Abbott Rapid Dx

申办方类型

Industry

责任方

Sponsor

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