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Clinical trial for verifying the accuracy of HPV nucleic acid detection with human papillomavirus (HPV) nucleic acid detection kit (PCR fluorescent probe method) of medium and high risk types (18 species)

Clinical trial for verifying the accuracy of HPV nucleic acid detection with human papillomavirus (HPV) nucleic acid detection kit (PCR fluorescent probe method) of medium and high risk types (18 species)

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100052676
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-08-08

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

Conditions

Cervical diseases

Interventions

Gold Standard:Test results of marketed comparison reagents
Index test:Human&#32
papillomavirus&#32
infection(PCR&#32
instrument)

Sponsors

Obstetrics and Gynecology Hospital Affiliated to Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Cervical samples from female patients aged >= 21 years in outpatient and/or inpatient patients; 2. The sample information is complete, clearly marked, and traceable to the original record.

Exclusion criteria

Exclusion criteria: 1. Other circumstances that the investigator considers unsuitable to participate in this clinical trial; 2. Contaminated samples; 3. Duplicate samples from the same patient.

Design outcomes

Primary

MeasureTime frame
Human papillomavirus;HPV positive;Positive coincidence rate;Negative coincidence rate;over-all coincidence rate;consistency;—

Countries

China

Contacts

Public ContactWang Hui

Obstetrics and Gynecology Hospital Affiliated to Medical College of Zhejiang University

5198008@zju.edu.cn+86 13958160137

Outcome results

None listed

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