Self-collected vaginal swab samples are processed in Color’s CLIA-certified and CAP-accredited labs. Color’s test uses the BD Onclarity™ Human papillomavirus (HPV) assay, which has been cleared by the U.S. Food and Drug Administration (FDA) for use with vaginal swab specimens. This assay is a qualitative in vitro test that uses polymerase chain reaction (PCR) amplification and nucleic acid hybridization to detect DNA from 14 high risk HPV types in a single analysis
High-risk HPV (hrHPV) types 16, 18, and 31, 45, 51 and 52 are individually reported. Detection of the remaining hrHPV types are reported in genotype groups: 33/58, 35/39/68, and 56/59/66 but are not individually reported (these are referred to as “other high-risk HPV types” on the report).