Detection of Enterovirus Genotypes by CRISPR Technology

June 7, 2023 updated by: Children's Hospital of Fudan University

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients with clinically suspected or confirmed enterovirus infection

Exclusion Criteria:

  • Patients with clinical diagnosis of non-enterovirus infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful construction of CRISPR-enterovirus detection system
Time Frame: 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.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EV-CRISPR.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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