Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Uterine Cervical Neoplasms

Treatments: Procedure: Colposcopy; Device: BD Onclarity™ HPV assay on BD Viper™ LT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01944722

BDS-USHPV

Details and patient eligibility

About

The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.

Enrollment: 33,858 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Females who are >21 years of age
• Females who provide informed consent

Exclusion criteria

• Known pregnant
• Cervical cytology specimen collected within the last 4 months
• Prior complete or partial hysterectomy involving removal of cervix
• Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
• Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
• Enrolled in a cervical disease diagnostic trial since 2007.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33,858 participants in 1 patient group

BD Onclarity™ HPV assay on BD Viper™ LT

Experimental group

Description:

The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results.

Treatment:

Procedure: Colposcopy

Device: BD Onclarity™ HPV assay on BD Viper™ LT