Co-Collection Study

Overview

Status: Enrolling by invitation
Keywords: Colposcopy
IRB Number: 00069942
Specialty: OB/Gyn, General
Sub Specialties: Colposcopy

Brief Summary

This proposal aims to compare the clinical performance of the cobas HPV Test using SurePath and ThinPrep preservatives. At the same time, results will be compared to those obtained with the HC2 assays when using SurePath and ThinPrep preservatives. Clinical sensitivity/specificity and positive/negative predictive values will be calculated for each test/preservative combination. Roche Linear Array HPV testing will be performed for discordant analysis and to determine infecting HPV types.

Principal Investigator: Robert Schlaberg
Department: Pathology
Co Investigator: Margit-Maria Janat-Amsbury

Contact Information

Name:Alexys Allen
Phone: (801) 581-6196
Email: alexys.allen@hsc.utah.edu

Inclusion Criteria

Participants will be enrolled based on scheduled visits for colposcopy within the University of Utah covered entity. Approximately 300 total participants will be enrolled. Samples collected for this study will be transported to ARUP Laboratories for testing using existing ARUP courier services and refrigerated until tested.

 

All women over age 18 with scheduled visits for colposcopy within the University of Utah covered entity are eligible to participate.

Exclusion Criteria

Women with a recent (previous 6 months) history of LEEP treatment will be excluded.

Women who are currently pregnant will be excluded.