Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
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.
Key Facts
Lead Sponsor
Becton, Dickinson and Company
Enrollment
33858
Start Date
2013-08-01
Completion Date
2016-03-01
Study Type
INTERVENTIONAL
Official Title
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Interventions
Conditions
Eligibility
Age Range
21 Years+
Sex
FEMALE
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.
Outcome Measures
Primary Outcomes
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
Time frame: Up to 14 weeks
Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).
Time frame: Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).
Time frame: Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).
Time frame: Up to 14 weeks
Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Time frame: Up to 14 weeks
Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Time frame: Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Time frame: Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Time frame: Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Time frame: Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Time frame: Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Time frame: Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Time frame: Up to 14 weeks
Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).
Time frame: Up to 14 weeks
Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).
Time frame: Up to 14 weeks
Non-reportable Rate of the BD Onclarity™ HPV Test
Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.
Time frame: Up to 14 weeks
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.
Time frame: Up to 14 weeks
Locations
University of Alabama Birmingham, Birmingham, United States
Mobile OB/GYN, Mobile, United States
Women's Health Research of Arizona, Phoenix, United States
Quality of Life Medical & Research Center, Tucson, United States
Visions Clinical Research, Tucson, United States
Women's Health Care Research Corp, San Diego, United States
West Coast Medical Research, San Diego, United States
Blueskies Center for Women, Colorado Springs, United States
Health Awareness Inc, Jupiter, United States
Altus, Lake Worth, United States
Segal Institute for Clinical Research, North Miami, United States
Miami Research Associates, South Miami, United States
Comprehensive Clinical Trials, LLC, West Palm Beach, United States
Medical Network for Education and Research, Decatur, United States
Fellows Research Associates - Savannah, Savannah, United States
Women's Health Practice, Champaign, United States
Indiana University, Indianapolis, United States
Four Rivers Clinical Research, Paducah, United States
Louisiana State University, New Orleans, United States
Saginaw Valley Medical Research, Saginaw, United States
Transgenomics, Omaha, United States
Vitura / Phoenix, Moorestown, United States
Meridian Health, Neptune City, United States
Q Squared Solutions, Teterboro, United States
TriCore Reference Laboratory, Albuquerque, United States
Research Pathology Associates, LLC, Irvington, United States
Montefiore Medical Center, The Bronx, United States
LabCorp, Burlington, United States
Eastern Carolina Women's Center, New Bern, United States
Lyndhurst Clinical Research, Winston-Salem, United States
HWC Women's Research Center, Englewood, United States
Center for Women's Health of Lansdale, Lansdale, United States
Clinical Research of Philadelphia, Philadelphia, United States
Reading Health Physicians Network, West Reading, United States
Fellows Research Associates - Bluffton, Bluffton, United States
James T Martin Jr, MD, North Charleston, United States
Chattanooga Medical Research, Chattanooga, United States
Center for Disease Detection (CDD), San Antonio, United States
Physicians Research Options, Draper, United States
Research Pathology Associates, Earlysville, United States
Tidewater Clinical, Virginia Beach, United States