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The study on the performance of targeted next-generation sequencing pathogen detection

Comparative study on the performance of targeted next-generation sequencing pathogen detection (tNGS)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073837
Enrollment
Unknown
Registered
2023-07-24
Start date
2023-07-24
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Respiratory infection

Interventions

Gold Standard:The mixed results were determined from microbiologic tests (BALF culture, mNGS, nucleic acid-based testing, antigen and antibody detection, and pathological examination) performed within

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with suspected pulmonary infection were subjected to bendable bronchoscopy. Metagenomic sequencing clinical tests were ordered during clinical diagnosis and treatment, and the remaining alveolar lavage fluid samples were detected to meet the 600µl required for tNGS detection. Complete basic clinical information was needed: subject name is replaced by digital code, gender, age, outpatient/hospitalization date, clinical diagnosis, blood routine results, clinical routine microbial culture results, clinical routine molecular detection results, clinical routine pathogen serum detection results

Exclusion criteria

Exclusion criteria: a. Samples that are not collected, processed, and stored in accordance with the requirements; b. Exclude samples with too little (less than 600 µl) remaining after meeting clinical routine tests c. Samples found to be contaminated before the test operation; d. Samples with incomplete clinical information.

Design outcomes

Primary

MeasureTime frame
Bacterial and fungal culture results;TB Xpert results;EB virus and cytomegalovirus nucleic acid test results;The clinician's assessment of the detected pathogen;GM results for plasma and BALF;Limit of Detection,LoD;accuracy;sensitivity;specificity;

Countries

China

Contacts

Public ContactHui Wang

Peking University People's Hospital

whuibj@163.com+86 186 1050 3998

Outcome results

None listed

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