Skip to content

Clinical Study of Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces)

Clinical Study of Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096535
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-01-24
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Rotavirus/Adenovirus infection

Interventions

Gold Standard:Virus isolation, antigen detection, serum specific antibody detection and metagenomic second generation sequencing.
Index test:Test in vitro diagnostic reagent product name: Rotavirus/adenovirus antigen detection kit (colloidal gold method) Packing: Card type, 25 servings/box

Sponsors

Children’s Hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: 1.The informed consent form of the child's guardians have been obtained; 2.<= 3 age(including borderline values) and gender; 3.Children meet one of the following conditions: symptoms of acute gastroenteritis (such as vomiting, diarrhea, etc.); symptoms similar to acute gastroenteritis.

Exclusion criteria

Exclusion criteria: Exclusion was required if any of the following criteria were met: 1.Age 4 and older; 2.The informed consent form of the child's guardians cannot be obtained; 3.Children without symptoms of acute gastroenteritis or similar symptoms; 4.Children cannot provide enough sample.

Design outcomes

Primary

MeasureTime frame
Positive percent agreement;Negative percent agreement;Overall percent agreement;Kappa value;

Countries

China

Contacts

Public ContactQing Ye

Children’s Hospital of Zhejiang University School of Medicine

qingye@zju.edu.cn+86 135 7576 1052

Outcome results

None listed

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