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Clinical trial of influenza A/B virus antigen detection kit (latex method)

Clinical trial of influenza A/B virus antigen detection kit (latex method)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098986
Enrollment
Unknown
Registered
2025-03-17
Start date
2024-01-11
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Influenza A+B

Interventions

Gold Standard:1. Viral nucleic acid detection 2. Viral antigen detection 3. Serological detection 4. Viral isolation and culture
Index test:Influenza A+B Rapid Test

Sponsors

Hangzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Informed consent form of the subjects have been obtained (Informed consent form of the guardians must be obtained for those under 18 years old). 2.Age (=60) and gender. 3. Subjects meet one of the following conditions: (1)symptoms/signs of influenza (e.g., cough, nasal congestion, rhinorrhea, sore throat, fever, headache, or myalgia). (2)flu-like symptoms. (3)people who have had close contact with a person with suspected or confirmed influenza within 7 days.

Exclusion criteria

Exclusion criteria: Exclusion was required if any of the following criteria were met: 1.People who do not have informed consent. 2.People who do not have influenza or flu-like symptoms/signs and have not had close contact with a suspected or confirmed influenza patient within 7 days.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactXianjun Wang

Hangzhou First People's Hospital

Wangxj0525@hotmail.com+86 138 5805 6365

Outcome results

None listed

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