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Application research on respiratory pathogen multi detection project based on fully automated nucleic acid analysis system

Application research on respiratory pathogen multi detection project based on fully automated nucleic acid analysis system

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099652
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Respiratory pathogen detection

Interventions

Gold Standard:Using existing respiratory testing reagents and instruments in the laboratory as reference methods (mNGS or tNGS)
Index test:Influenza A virus, influenza B virus, novel coronavirus, respiratory syncytial virus, chlamydia psittaci, Boca virus, chlamydia pneumoniae, EB virus, mycoplasma pneumonia, human rhinovirus,

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 99 Years

Inclusion criteria

Inclusion criteria: Patients who seek medical treatment at the Second People's Hospital of Shenzhen with respiratory infection symptoms, regardless of age or gender, are required to collect residual samples (bronchoalveolar lavage fluid or sputum) that have undergone mNGS or tNGS clinical testing.

Exclusion criteria

Exclusion criteria: Samples with a volume of less than 500 µ L are considered invalid samples; Samples excluded due to instrument or human factors (detection process failure and retesting still failing or unable to retest).

Design outcomes

Primary

MeasureTime frame
Influenza A virus; influenza B virus;novel coronavirus;respiratory syncytial virus;Boca virus;chlamydia pneumoniae;EB virus; mycoplasma pneumonia;human rhinovirus;human metapneumovirus;adenovirus;human cytomegalovirus;pneumocystis; parainfluenza virus (type 1, 2, 3);Legionella pneumophila; adenovirus type 7;Bordetella pertussis;haemophilus influenzae;Acinetobacter baumannii;Pseudomonas aeruginosa;Streptococcus pneumoniae;klebsiella pneumoniae;moraxella catarrhalis;Staphylococcus aureus;

Secondary

MeasureTime frame
chlamydia psittaci;coronavirus 229E/NL63; coronavirus HKUI/OC43;

Countries

China

Contacts

Public ContactGu Dayong

Shenzhen Second People's Hospital

wanhood@163.com+86 136 0260 1597

Outcome results

None listed

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