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

Study:

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

Rationale:

n/a

Purpose:

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.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Human Papillomavirus Infection n/a N/A

Verified by Gen-Probe, Incorporated October, 2011

Sponsored by: Gen-Probe, Incorporated
Information provided by: Gen-Probe, Incorporated
ClinicalTrials.gov identifier: NCT01384370

Study Type: Interventional

Study Design: Observational Model: Case Control, Time Perspective: Retrospective

Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Tadd S Lazarus, M.D.., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.