HPV Typing Between Self- and Physician-sampled

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

Eligibility Criteria:
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