Detection of Enterovirus Genotypes by CRISPR Technology

Enterovirus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04535648
• Other study ID #: EV-CRISPR.001
• Status: Withdrawn
• Start date: April 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria:

• Patients with clinically suspected or confirmed enterovirus infection

Exclusion Criteria:

• Patients with clinical diagnosis of non-enterovirus infection

Related Conditions & MeSH terms

• Enterovirus Infections

Intervention

Other:
• Non-invasive detection method: CRISPR techonology
This study was a laboratory diagnostic study without any intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: the positive coincidence rate and negative coincidence rate are both over 95.0%; the value of Kappa using to express the consistency of those two methods is over 0.75; the sensitivity and specificity of the CRISPR-enterovirus detection system for detection of enterovirus are over 90.0% and 95.0%; the coefficient of variation between batches is less 15.0%, and each batch detection takes less than 1 hour.	At enrollment