NCT01917422已完成不适用
Clinical Specimens Testing Program of Dengue Antigen Detection Reagents
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Clinical specimens testing program of dengue antigen detection reagents
研究概览
简要总结
Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.
详细描述
The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A total of 95 cases and 100 controls (suspected cases(>50 %) and normal subjects) are expected to enroll.
- •Case group: adults having a medical visit or admission due to dengue / dengue hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC). Any of the following positive test results for the case of 100 adults.
- •clinical specimens (blood) isolated and identified dengue virus.
- •clinical specimens positive for molecular detection of nucleic acids.
- •serological antigen (referring to non-structural proteins of dengue virus non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad DENGUE NS1 Ag STRIP).
- •paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
- •Suspected cases: adults having medical visits or admissions due to infectious disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP), immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were negative.
- •Control group: adults without having medical visits or admissions due to Fever. -
排除标准
- •non-adult case -
结局指标
主要结局
Clinical specimens testing program of dengue antigen detection reagents
时间窗: one year
Calculate two products of the dengue immune detection accuracy, sensitivity, specificity, false positive, false negative.
次要结局
未报告次要终点
研究者
研究点 (1)
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