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Clinical evaluation of the application of the BIOFIRE® SPOTFIRE® Respiratory Panel in pediatric patients with upper respiratory tract infections

Clinical evaluation of the application of the BIOFIRE® SPOTFIRE® Respiratory Panel in pediatric patients with upper respiratory tract infections

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120327
Enrollment
Unknown
Registered
2026-03-12
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Upper Respiratory Tract Infection

Interventions

Gold Standard:Caidui Twelve Respiratory Pathogen Nucleic Acid Detection Kit
Index test:BIOFIRE® SPOTFIRE® Respiratory Panel

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1.>28 days and <18 years; 2.Outpatients or inpatients diagnosed with a respiratory tract infection; 3.Informed consent was obtained from the legal guardians and the pediatric patients themselves.

Exclusion criteria

Exclusion criteria: 1.Age =18 years; 2.Diagnosed with a non-respiratory infection; 3.Inability or unwillingness to provide informed consent;

Design outcomes

Primary

MeasureTime frame
Positive Percent Agreement (PPA);Overall Percent Agreement (TPA);—

Secondary

MeasureTime frame
Negative Percent Agreement (NPA);—

Countries

China

Contacts

Public ContactYue Tao

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

taoyue@scmc.com.cn+86 21 3808 7378

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026