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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


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




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


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 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

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