Determination of Estimated Sensitivity for Dengue NS1 ELISAs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 911
- 试验地点
- 5
- 主要终点
- number of subjects with positive result
研究概览
简要总结
This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and internationally.
The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing with a reference standard test.
Subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. The first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms.
ELISA and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All age groups and both sexes.
- •Initial serum samples must be collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
- •Information must be available about symptoms, age, and sex of patient from which samples are collected.
- •The location of sample collection must be recorded.
- •Archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for inclusion as test specimens in this study. If these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection.
排除标准
- •Archived samples with linked personal identifiers or any sample for which personal information can be discovered.
- •Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent.
- •Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
结局指标
主要结局
number of subjects with positive result
时间窗: 1 day
次要结局
未报告次要终点