European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System

Status Completed

Clinical Trial Summary

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.

Clinical Trial Description

This is a multicenter study consisting of 2-3 European clinical trial sites, and up to 2 BD Viper LT Systems.

The BD HPV Diluent tube will be run on the BD HPV assay with the Viper LT instrument and compared to histology, Digene hybrid capture 2 (HC2), and Roche LINEAR ARRAY HPV Genotyping Test results. ;

Study Design

N/A

Related Conditions & MeSH terms

Uterine Cervical Neoplasms

Clinical Trial Details

NCT number	NCT01671462
Study type	Observational
Source	Becton, Dickinson and Company
Contact
Status	Completed
Phase	N/A
Start date	August 2012
Completion date	November 2013

View Details

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