Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic
 Acid Assay Kit. This is a multi-center clinical study involving at least three study centers,
 each with screening sites. The protocol describes two study phases: Phase I is a baseline
 study of the screened population and ASCUS referral population (if necessary), the data of
 which will be submitted after the baseline study is completed; Phase II is a three-year
 follow-up study of the screened population, the data of which will be submitted again after
 the follow-up is completed.
Inclusion Criteria:

 -  Female subjects ≥ 21 of age and < 65 of age

 -  Subjects who have signed the inform consent form

 Exclusion Criteria:

 -  Pregnant subjects

 -  Subjects who have had cervical cytology samples taken in the last 12 months

 -  Subjects who have previously undergone a total hysterectomy

 -  Subjects who have previously undergone cone resection, LEEP, cervical laser surgery,
 cervical cryosurgery or uterine ablation within 3 years

 -  Subjects who are participating in other clinical trials of cervical disease diagnostic
 products