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