NCT01384370

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

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,260 (estimated)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Human Papillomavirus Infection

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-06-29
• Last updated: 2011-10-06

Locations

3 sites across 1 country: United States