Evaluation of the Q-Pad hrHPV Test System Using At-Home Menstrual Blood Collection to Detect Cervical Precancer

What this Trial Is About

Researchers are evaluating the Q-Pad hrHPV Test System to detect high-risk human papillomavirus hrHPV, the virus responsible for most cervical cancers, using menstrual blood collected at home. This multicenter prospective study involves adults referred for colposcopy after abnormal cervical screening results. The goal is to compare hrHPV detection from menstrual samples with standard cervical samples and biopsy findings to assess the test systems diagnostic accuracy and participant acceptability. Participants receive a mailed Q-Pad Kit containing special menstrual pads with removable collection strips and instructions, including an optional smartphone app. They collect menstrual blood at home during their period and mail the samples to a central laboratory for hrHPV testing using PCR. At the colposcopy visit, a clinician collects a cervical specimen for routine hrHPV testing and performs colposcopy with biopsy as needed. During the study, participants provide both at-home menstrual and clinician-collected cervical samples within the same care episode. Researchers assess hrHPV test results, safety, specimen adequacy, and participant usability and acceptability of the Q-Pad system. Outcome measures include clinical performance compared to histology, device-related adverse events, agreement between tests, and validity rates. The study lasts about one year, with follow-up through study completion.

Evaluation of the Q-Pad hrHPV Test System for Identifying Precancer