APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
In both the ASC-US Study and Adjunct Study populations, the objectives are to:

 -  evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical
 disease in women with APTIMA HPV Assay positive results and

 -  evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45
 in women with APTIMA HPV Assay positive results.
The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid
 amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human
 papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with positive
 results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive
 for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV
 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap
 Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with
 commercially available collection devices (broom-type collection device or cytobrush/spatula
 combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The
 assay is used with the TIGRIS DTS (TIGRIS) System.

 In both the ASC-US Study and Adjunct Study populations, the objectives are to:

 -  evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical
 disease in women with APTIMA HPV Assay positive results and

 -  evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45
 in women with APTIMA HPV Assay positive 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).