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Performance Assessment of Rapid Detection Kit for Respiratory Infections

Performance Verification and Evaluation of Nucleic Acid CRISPR Rapid Detection Kit for Respiratory Pathogens and Drug Resistance Genes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098381
Enrollment
Unknown
Registered
2025-03-06
Start date
2024-10-18
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Respiratory Tract Infections

Interventions

Gold Standard:Pathogen culture method or PCR detection method
Index test:Utilize the CRISPR-based rapid nucleic acid detection method to screen for the following pathogens and antibiotic resistance genes: Influenza A virus, Influenza B virus, SARS-CoV-2 (COVID-1

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 95 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 95 years, gender not limited. 2.Suspected infected patients with respiratory symptoms or confirmed patients with untreated respiratory infections. 3.Retrospective sample collection uses previously remaining samples with the original informed consent; prospective sample collection is divided into two situations: First, additional collection of oropharyngeal swabs or sputum requires participants to sign a separate informed consent form; Second, the use of routine examination remaining samples, pleural effusion, or bronchoalveolar lavage fluid uses the general informed consent form signed upon hospital admission. 4.Patients can collect oropharyngeal swabs, sputum, bronchoalveolar lavage fluid, or pleural effusion samples. 5.Healthy volunteers: (1) Sign the informed consent form; (2) Age between 18 and 95 years, gender not limited; (3) Do not suffer from respiratory tract infections included in this study; (4) Do not have upper respiratory symptoms such as cough or rhinorrhea.

Exclusion criteria

Exclusion criteria: 1.Patients with incomplete medical records or untraceable sources. 2.The sample collection does not meet the research requirements. 3.Patients or healthy individuals outside the age range included in this study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Overall Agreement Rate;

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