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. One of the benefits 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 a PCR-based clinically validated HPV assay is used. However, there are few clinically validated, PCR-based, HPV assays with on-label claims for self-collection.