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Brief Title: Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Official Title: Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Study ID: NCT01944722
Brief 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.
Detailed Description:
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
University of Alabama Birmingham, Birmingham, Alabama, United States
Mobile OB/GYN, Mobile, Alabama, United States
Women's Health Research of Arizona, Phoenix, Arizona, United States
Quality of Life Medical & Research Center, Tucson, Arizona, United States
Visions Clinical Research, Tucson, Arizona, United States
Women's Health Care Research Corp, San Diego, California, United States
West Coast Medical Research, San Diego, California, United States
Blueskies Center for Women, Colorado Springs, Colorado, United States
Health Awareness Inc, Jupiter, Florida, United States
Altus, Lake Worth, Florida, United States
Segal Institute for Clinical Research, North Miami, Florida, United States
Miami Research Associates, South Miami, Florida, United States
Comprehensive Clinical Trials, LLC, West Palm Beach, Florida, United States
Medical Network for Education and Research, Decatur, Georgia, United States
Fellows Research Associates - Savannah, Savannah, Georgia, United States
Women's Health Practice, Champaign, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
Four Rivers Clinical Research, Paducah, Kentucky, United States
Louisiana State University, New Orleans, Louisiana, United States
Saginaw Valley Medical Research, Saginaw, Michigan, United States
Transgenomics, Omaha, Nebraska, United States
Vitura / Phoenix, Moorestown, New Jersey, United States
Meridian Health, Neptune, New Jersey, United States
Q Squared Solutions, Teterboro, New Jersey, United States
TriCore Reference Laboratory, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Research Pathology Associates, LLC, Irvington, New York, United States
LabCorp, Burlington, North Carolina, United States
Eastern Carolina Women's Center, New Bern, North Carolina, United States
Lyndhurst Clinical Research, Winston-Salem, North Carolina, United States
HWC Women's Research Center, Englewood, Ohio, United States
Center for Women's Health of Lansdale, Lansdale, Pennsylvania, United States
Clinical Research of Philadelphia, Philadelphia, Pennsylvania, United States
Reading Health Physicians Network, West Reading, Pennsylvania, United States
Fellows Research Associates - Bluffton, Bluffton, South Carolina, United States
James T Martin Jr, MD, North Charleston, South Carolina, United States
Chattanooga Medical Research, Chattanooga, Tennessee, United States
Center for Disease Detection (CDD), San Antonio, Texas, United States
Physicians Research Options, Draper, Utah, United States
Research Pathology Associates, Earlysville, Virginia, United States
Tidewater Clinical, Virginia Beach, Virginia, United States
Name: Charles Cooper, MD
Affiliation: Becton, Dickinson and Company
Role: STUDY_DIRECTOR