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Rotavirus Antigen Rapid Test Kit (Colloidal Gold) Clinical trial

Multi-center Clinical Trial for Detecting Rotavirus Antigen in Stool with Colloidal Gold Rapid Test

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025927
Enrollment
Unknown
Registered
2019-09-14
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-16

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

Conditions

Infantile Rotavirus Antigen Infection

Interventions

Gold Standard:Results of colloidal gold method or artificial microscopic examination of rotavirus in clinical departments.
Index test:Rotavirus&#32
Detection&#32
Kit&#32
Immunochromatography)&#32
(AVE&#32
Technology&#32

Sponsors

Zhejiang Provincial Center for Disease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clear information of subjects; 2. The sample size of the subjects is sufficient.

Exclusion criteria

Exclusion criteria: 1. Stool samples collected again by the same subject; 2. Stool samples with unclear sample collection time or subject information; 3. Fecal samples with insufficient or excessive amount of samples due to errors during the test operation; 4. Stool samples contaminated during the test operation; 5. The stool sample that the researcher believes does not meet the testing requirements.

Design outcomes

Primary

MeasureTime frame
Kappa;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactLiu HaiYing

Guangzhou Women and Children Medical Center

xiangliuhaiying@aliyun.com+86 189 0226 8993

Outcome results

None listed

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