To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).
To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).
Primary Effectiveness Objective
• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:
* Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
* Calculating the invalid rate of tested samples.
