European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
N/A
N/A
Female
Uterine Cervical Neoplasms
Trial Information
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
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.
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.
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
Outcome Description:
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
Outcome Time Frame:
Nine months
Safety Issue:
No
Principal Investigator
Irene Hannet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Becton, Dickinson and Company
Authority:
Italy: Ethics Committee
Study ID:
MDX-11-EUHPV
NCT ID:
NCT01671462
Start Date:
August 2012
Completion Date:
May 2013
Related Keywords:
- Uterine Cervical Neoplasms
- HPV
- Cervical Cancer
- Cervical Neoplasms
- Neoplasms
- Uterine Cervical Neoplasms
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