Detection of Enterovirus Genotypes by CRISPR Technology

Sponsor

Children's Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04535648

Collaborator

(none)

500

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enterovirus Infections	Other: Non-invasive detection method: CRISPR techonology

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Outcome Measures

Primary Outcome Measures

Successful construction of CRISPR-enterovirus detection system [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： 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with clinically suspected or confirmed enterovirus infection

Exclusion Criteria:

Patients with clinical diagnosis of non-enterovirus infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

Study Director: Liling Qian, Children's Hospital of Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT04535648

Other Study ID Numbers:

EV-CRISPR.001

First Posted:

Sep 2, 2020

Last Update Posted:

Feb 14, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Enterovirus Infections

Study Results

No Results Posted as of Feb 14, 2022