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

Study Overview
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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.

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.

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

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Device: BD HPV assay on Viper LT


Participation Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BD HPV assay on Viper LT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. | Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater | Nine months | 
| Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. | Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2. | Nine months | 
| Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. | Positive Predictive Value is calculated: Number of subjects with a positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with a positive BD HPV test. | Nine months | 
| Negative Predictive Value (NPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher. | Negative Predictive Value is calculated: Number of subjects with a negative result for the BD HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD HPV test. | Nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positive percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test | Positive percent agreement is calculated: The number of subjects with positive BD HPV test and positive results for the HC2 test and Roche Linear Array HPV divided by total of subjects with positive results for HC2 test and Roche Linear Array HPV. | 9 months | 
| Negative percent agreement of the BD HPV Assay compared to digene hybrid capture (HC2) test and Roche LINEAR ARRAY HPV Genotyping Test | Negative percent agreement is calculated: The number of subjects with negative BD HPV test and negative results for the HC2 test and Roche Linear Array HPV divided by total of subjects with negative results for HC2 test and Roche Linear Array HPV test. | Nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Cervical Cancer, Cervical Neoplasms