跳至主要内容
临床试验/NCT04535648
NCT04535648撤回不适用

Rapid Identification and Clinical Transformation of Various Enterovirus Genotypes Based on CRISPR Technology

Children's Hospital of Fudan University0 个研究点开始时间: 2023年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Successful construction of CRISPR-enterovirus detection system

研究概览

简要总结

CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection.

详细描述

To construct CRISPR-enterovirus detection system, we screened the targets, primers and CrRNA and evaluated the capability of this detecting system. Samples of feces, blood and cerebrospinal fluid (the remainder of routine testing samples) from 500 children with suspected or confirmed enterovirus infection were examined using the CRISPR technique. To evaluate the CRISPR-enterovirus detection system, real-time PCR and traditional PCR as comparison method was implemented. The method of real-time PCR and traditional PCR were used to detect enterovirus and analyze the genotypes of enterovirus, respectively. According to the results of CRISPR-enterovirus detection system and the comparison method, the positive coincidence rate, negative coincidence rate and consistency of the two methods were calculated. Furthermore, the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus were calculated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinically suspected or confirmed enterovirus infection

排除标准

  • Patients with clinical diagnosis of non-enterovirus infection

结局指标

主要结局

Successful construction of CRISPR-enterovirus detection system

时间窗: At enrollment

It is a binary variable ("yes/no").If the system meet all the following criteria, it would be setted into "yes" .According to the results of CRISPR-enterovirus detection system and the comparison method: 1. the positive coincidence rate and negative coincidence rate are both over 95.0%; 2. the value of Kappa using to express the consistency of those two methods is over 0.75; 3. the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus are over 90.0% and 95.0%; 4. the coefficient of variation between batches is less 15.0%, and each batch detection takes less than 1 hour.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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