Clinical Evaluation of QFlu Combo Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 506
- 试验地点
- 3
- 主要终点
- Sensitivity and specificity for drug resistance detection
研究概览
简要总结
Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.
详细描述
The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specificity for drug resistance detection
时间窗: approximately 12 months after the study is completed.
Interim results may be assessed after the first year study.
次要结局
- Sensitivity and Specificity of the Test for Influenza Diagnosis(12 months after the study is completed.)