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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Uterine Cervical Neoplasms

Interventions

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BD HPV assay on Viper LT

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Referred to follow up due to one or more abnormal Pap or an HPV infection
* Subjects who have provided informed consent
* Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines.

Exclusion Criteria

* Known to be pregnant
* With prior complete or partial hysterectomy involving removal of cervix
* Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds.
* Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No