Cervical Intraepithelial Neoplasia, HPV Infection, Human Papillomavirus Infection
Conditions
Brief summary
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard.
Detailed description
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer. HPV testing and risk stratification by genotyping has been recognized as an effective cervical screening program. HPV detection is also applied for triage of atypical squamous cells of undetermined significance and follow-up after treatment for cervical neoplasms. A chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA sequencing as the gold standard. One-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua Christian Hospital, and Cathay General Hospital.
Interventions
DEVICEDR. Chip HPV genotyping IVD kit
HPV typing by gene chip
Sponsors
Dr. Chip Biotechnology Incorporation
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 21-65 y/o female with sexual exposure 2. Written informed consent 3. Either one of the following conditions: 3a. No previous history of abnormal cervical cytology or abnormal histology for women enrolled in no intraepithelial lesion or malignancy (NILM) group 3b. Abnormal cervical cytology other than atrophic change, reactive change or glandular cells favored of the endometrial origin
Exclusion criteria
1. Current pregnancy 2. Previous total hysterectomy 3. Cervicovaginal infection required treatment 4. Received cervical ablative therapy within 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement | within one week after sample collected by a study physician | agreement, sensitivity, and specificity compared to DNA sequencing |
Countries
Taiwan
Outcome results
None listed