Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
Agreement of hrHPV Type Between Self-collected Sample From Vaginal Fornix and Physician Collected Sample From the Cervical Surface
Hygeia Touch Inc. developed a safe and comfortable vaginal self-sampling device "Hygeia Touch
 Self Sampling Kit for Women" to self-collect the vaginal discharge sample for high-risk Human
 Papillomavirus (hrHPV) detection.

 This clinical trial aimed to evaluate the agreement of hrHPV detections between vaginal
 self-sampling using "Hygeia Touch Self Sampling Kit for Women" and physician sampling, and
 these results will be applied for TFDA registration approval.
Primary end-point:

 1. Agreement of hr-HPV types, including types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58,
 59, 66, and 68, between the physician-collected sample and self-collected sample

 2. Agreement of the presence of hr-HPV between the physician-collected sample and
 self-collected sample

 Secondary end-point:

 1. percentage of the valid sample between self-collected and physician-collected specimens

 2. Agreement of all (N = 27) HPV types between the paired samples

 3. Adverse events associated with sample collection

 4. Questionnaire of the appreciation and satisfaction of using self-collecting vaginal
 discharge sample using "Hygeia Touch Self Sampling Kit for Women" through a short movie
 and a brief illustration

 5. Correlation between histological diagnosis and HPV types
Inclusion Criteria:

 1. Woman with a uterine cervix, i.e., with no previous total hysterectomy or radiotherapy
 for cervical tumor. The woman who received subtotal hysterectomy is allowed.

 2. Signed informed consent. 3. Fit any one of the following conditions,

 1. with no history or current cervical intraepithelial lesion or malignancy.

 2. with a history of abnormal Pap test including atypical squamous cells of undetermined
 significance, cervical intraepithelial neoplasia grade 1, or atypical glandular cell.

 3. with a history of atypical squamous cells favor high-grade squamous intraepithelial
 lesion, dysplasia cannot exclude high-grade squamous intraepithelial lesion, cervical
 intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3,
 cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells favor
 neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.

 4. with current atypical squamous cells of undetermined significance, cervical
 intraepithelial neoplasia grade 1, or atypical glandular cell.

 5. with current abnormal Pap test as atypical squamous cells favor high-grade squamous
 intraepithelial lesion, dysplasia cannot exclude high-grade squamous intraepithelial
 lesion, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia
 grade 3, cervical carcinoma in situ, squamous cell carcinoma, atypical glandular cells
 favor neoplasm, adenocarcinoma in situ, or cervical adenocarcinoma.

 Exclusion Criteria:

 1. History of total hysterectomy

 2. Pregnant

 3. Current cervicitis that requires therapy

 4. Received treatment for cervical lesion within 90 days

 5. Had undergone radiotherapy or is receiving radiation over the uterus, cervix or vagina

 6. Had sexual activity without a condom in 48 hours

 7. Excessive vaginal discharge, either in the ovulation period or due to inflammation

 8. is undergoing local therapy with an intravaginal tablet or residual drug in the
 vaginal canal

 9. during mense