Primary end-point:~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~Agreement of the presence of hr-HPV between the physician-collected sample and self-collected sample~Secondary end-point:~Percentage of the valid sample between self-collected and physician-collected specimens~Agreement of all (N = 27) HPV types between the paired samples~Adverse events associated with sample collection~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~Correlation between histological diagnosis and HPV types
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.