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Evaluation on the performance of the diagnostic accuracy of the NuRapid-CRISPR-TB assay and the drug resistance of Mycobacterium tuberculosis assay by CRISPR real-time quantitative PCR method

Evaluation on the performance of the diagnostic accuracy of the NuRapid-CRISPR-TB assay and the drug resistance of Mycobacterium tuberculosis assay by CRISPR real-time quantitative PCR method

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105189
Enrollment
Unknown
Registered
2025-06-30
Start date
2024-01-03
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Observation group:None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Initial diagnosis, untreated; 2. Patients with respiratory symptoms and preliminary diagnosis of Mycobacterium tuberculosis infection; 3. Sign the informed consent form; 4. Mycobacterium tuberculosis detection kit (Saipei PCR fluorescence method) will be performed; 5. There are culture results of Mycobacterium tuberculosis.

Exclusion criteria

Exclusion criteria: 1.Subjects with incomplete case information or untraceable records. 2.Subjects excluded due to the type of sample collected or insufficient sample volume for the study requirements.

Design outcomes

Primary

MeasureTime frame
Repeatability;detection limit;Compliance rate, repeatability;—

Countries

China

Contacts

Public ContactJi Yuan

Zhongshan Hospital, Fudan University

ji.yuan@zs-hospital.sh.cn+86 13681858366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026