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This clinical trial has been terminated。
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CRISPR-enterovirus detection system was constructed in this study for detection variety genotypes of enterovirus rapidly in children suspected or diagnosed as enterovirus infection.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive detection method: CRISPR techonology | Other | This study was a laboratory diagnostic study without any intervention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful construction of CRISPR-enterovirus detection system | 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：
| At enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who came to the Children's Hospital of Fudan University and were diagnosed with enterovirus infection.
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| Name | Affiliation | Role |
|---|---|---|
| Liling Qian | Children's Hospital of Fudan University | Study Director |
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| ID | Term |
|---|---|
| D004769 | Enterovirus Infections |
| ID | Term |
|---|---|
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Samples of feces, blood and cerebrospinal fluid (the remainder of routine testing samples) from 500 children with suspected or confirmed enterovirus infection were collected for detection by the CRISPR technique.