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

NCT01944722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33858

Last updated 2018-06-12

Study results available
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Summary

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.

Conditions

  • Uterine Cervical Neoplasms

Interventions

DEVICE

BD Onclarity™ HPV assay on BD Viper™ LT

The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.

PROCEDURE

Colposcopy

Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Charles Cooper, MD · Becton, Dickinson and Company

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944722 on ClinicalTrials.gov