APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

Inclusion Criteria: * • the subject attended a colposcopy visit, and * the referral Pap sample had a valid APTIMA HPV Assay result, and * the sample had an APTIMA HPV Assay positive result, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 \[CIN2\] or more severe (eg, CIN2, CIN grade 3 \[CIN3\], or cervical cancer; "CIN2+"), or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (\<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and * the sample had an APTIMA HPV Assay positive result, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of \<CIN2 and was randomly selected for inclusion. Exclusion Criteria: * Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).