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

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Uterine Cervical Neoplasms

Treatments: Device: BD HPV assay on Viper LT

Study type: Observational

Funder types: Industry

Identifiers

NCT01671462

MDX-11-EUHPV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,365 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.