Detection of Enterovirus Genotypes by CRISPR Technology

NCT ID: NCT04535648

Last Updated: 2023-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Enterovirus Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Non-invasive detection method: CRISPR techonology

This study was a laboratory diagnostic study without any intervention.

Intervention Type OTHER

Other Intervention Names

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No intervention

Eligibility Criteria

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Inclusion Criteria

* Patients with clinically suspected or confirmed enterovirus infection

Exclusion Criteria

* Patients with clinical diagnosis of non-enterovirus infection
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liling Qian

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Other Identifiers

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EV-CRISPR.001

Identifier Type: -

Identifier Source: org_study_id

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