Detection of Enterovirus Genotypes by CRISPR Technology

NCT04535648 | Withdrawn

• 1 other identifier: EV-CRISPR.001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Enterovirus Infections

Outcome Measures

Primary Outcomes (1)

• 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： 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.

  At enrollment

Interventions

Non-invasive detection method: CRISPR techonology OTHER

This study was a laboratory diagnostic study without any intervention.

Also known as: No intervention

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients who came to the Children's Hospital of Fudan University and were diagnosed with enterovirus infection.

You may qualify if:

• Patients with clinically suspected or confirmed enterovirus infection

You may not qualify if:

• Patients with clinical diagnosis of non-enterovirus infection

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Enterovirus Infections

Condition Hierarchy (Ancestors)

Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Liling Qian

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 2, 2020
• Study Start: April 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share