Color’s HPV Test uses the FDA-approved BD Onclarity HPV Assay to detect high-risk HPV types associated with cervical cancer using self-collected vaginal swab samples. The test also includes built-in specimen adequacy control to ensure samples are suitable for testing. Studies have shown self-collected vaginal swab specimens demonstrated strong agreement with clinician-collected cervical specimens when tested using the BD Onclarity HPV assay on the BD Viper LT System.
In a US study of individuals representative of the general cervical cancer screening population, when collected with the Onclarity™ Self-Collection Kit and tested with the BD Onclarity™ HPV Assay, vaginal samples detected HPV in 93% of HPV positive clinician-collected cervical samples. No cancer screening is 100% accurate but this data supports the use of self-collected vaginal swab specimens as a reliable option for at-home cervical cancer screening.