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临床试验/NCT01388049
NCT01388049Unknown不适用

e- Ab Sensor - Based Real-time Diagnosis of Enterovirus Type 71

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
72
试验地点
2
主要终点
The performance of e- Ab sensor

研究概览

简要总结

To develop a real-time diagnostic technique with e- Ab sensor for Entervirus 71 detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Entervirus 71, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give EV71 patients early treatment to reduce the complications and case-fatality rate.

详细描述

Entervirus 71 is one of the most important infectious diseases in children and the important concern in public health. Since 1998, EV71 has become an endemic disease in Taiwan and caused hundreds of severe cases and dozens of fatal cases each year due to lack of EV71 vaccine. Family transmission study also showed that it is highly contagious among households as well as in daycares or kindergartens. Therefore, a rapid diagnosis is clinically necessary and can provide clinicians the rapid answers and make early treatment possible to reduce the complications and case-fatality rate. In addition, early diagnosis of the patients will alert parents and public health workers to prevent the contacts earlier and to limit the EV71 spread.

Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between Q.anti-EV71 and its antigen EV71 present in EV71 patients and normal sample. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eVchip) or lateral flow through (eVsignal) formats. In electrosensing virus probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds EV71 epitope target molecules in the test serum. In comparison with results from direct sequencing of EV71, the investigators evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. e- Ab sensor threshold decisions must maximize its sensitivity. Therefore, the threshold value in the test group is to find the decision could have 90% sensitivity and 90% specificity. With such technique, the investigators hope to make early diagnosis and give EV71 patients early treatment to reduce the complications and case-fatality rate.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • A: The patients with confirmed or suspected infection.
  • B: The patients without disease.

排除标准

  • Patients will be excluded if they couldn't sign the consent.

结局指标

主要结局

The performance of e- Ab sensor

时间窗: 1 Day

In comparison with results from direct sequencing of EV71, we evaluate the performance of e- Ab sensor, including reproducibility, sensitivity, specificity, and cross-reaction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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