Clinical Validation of the Roche cobas and cobas 4800 Human Papillomavirus Tests on Self-Collected Vaginal Dry Swabs versus Practitioner-Collected Cervical Specimens Using the VALHUDES Protocol.

The first national human papillomavirus (HPV)-based cervical screening programs began in 2017. Since then, a growing list of countries have moved, or want to move, to HPV-based screening. A benefit of HPV-based screening is that a sample does not need to be collected from the cervix by a health care practitioner. Self-collection has been demonstrated to give equivalent accuracy as practitioner-collected specimens when PCR-based clinically validated HPV assays are used. However, there are few clinically validated, PCR-based, HPV assays with on-label claims for self-collection. The current study, Self-Collection or Practitioner-Collection Evaluation 2 (SCoPE2), undertook a Validation of Human Papillomavirus Assays and Collection Devices for Self-Samples and Urine Samples (VALHUDES) protocol evaluation with individuals recruited in a colposcopy population in the context of an HPV-based screening program. SCoPE2 recruited 400 participants who took self-collected vaginal samples using a FLOQSwab. Practitioner-collected cervical samples were collected at colposcopy. HPV testing was performed using both the cobas 4800 and cobas HPV tests. The self-collected specimens demonstrated equivalent and noninferior relative sensitivity for histologically confirmed cervical intraepithelial neoplasia grade ≥2 (CIN2+) (n = 58) when compared with the practitioner-collected specimen for cobas 4800 (0.982) and cobas (1.037), but relative specificity was inferior. Additional analyses were undertaken to resolve referral, self-collected, and practitioner-collected discordant results. SCoPE2 demonstrates that self-collection is noninferior for detection of CIN2+ compared with a practitioner-collected specimen.