Uterine Cervical Neoplasms
Conditions
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.
Interventions
DEVICEBD 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.
PROCEDUREColposcopy
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
Becton, Dickinson and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | Up to 14 weeks | 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). |
| Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | Up to 14 weeks | 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). |
| Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | Up to 14 weeks | 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). |
| Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | Up to 14 weeks | 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). |
| Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | Up to 14 weeks | 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. |
| Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | Up to 14 weeks | 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. |
| Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | Up to 14 weeks | 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. |
| Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | Up to 14 weeks | 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. |
| Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | Up to 14 weeks | 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. |
| Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | Up to 14 weeks | 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. |
| Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | Up to 14 weeks | 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. |
| Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | Up to 14 weeks | 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. |
| 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) | Up to 14 weeks | 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). |
| 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) | Up to 14 weeks | 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). |
| Non-reportable Rate of the BD Onclarity™ HPV Test | Up to 14 weeks | 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. |
| Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. | Up to 14 weeks | Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASCUS Aged 21 Years and Older Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | 1,960 |
| NILM Aged 30 Years and Older Participants aged 30 years and older and having cytology results that are negative for intraepithelial lesions or malignancy (NILM). | 22,383 |
| Total | 24,343 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | >ASCUS Cytology | 1,122 |
| Overall Study | Didn't meet Inclusion/Exclusion Criteria | 171 |
| Overall Study | Improper Storage/Transport | 5 |
| Overall Study | Insufficient Volume for Test | 1 |
| Overall Study | Missing Specimens | 3 |
| Overall Study | NILM Subjects <30 years old | 8,106 |
| Overall Study | Specimen Shipping Issues | 34 |
| Overall Study | Specimens Mislabeled | 2 |
| Overall Study | Unsatisfactory Cytology Result | 63 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | ASCUS Aged 21 Years and Older | Total | NILM Aged 30 Years and Older |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 11.5 | 43.3 years STANDARD_DEVIATION 10 | 43.9 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 303 Participants | 4895 Participants | 4592 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1657 Participants | 19446 Participants | 17789 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants | 104 Participants | 97 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 356 Participants | 336 Participants |
| Race (NIH/OMB) Black or African American | 459 Participants | 4181 Participants | 3722 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 64 Participants | 60 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 204 Participants | 180 Participants |
| Race (NIH/OMB) White | 1446 Participants | 19434 Participants | 17988 Participants |
| Region of Enrollment United States | 1960 Participants | 24343 Participants | 22383 Participants |
| Sex: Female, Male Female | 1960 Participants | 24343 Participants | 22383 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 33,858 |
| other Total, other adverse events | 0 / 33,858 |
| serious Total, serious adverse events | 9 / 33,858 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 18 Positive | 16.7 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive | 22.3 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16 Positive | 29.5 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other High Risk HPV Positive | 10.9 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 45 Positive | 7.5 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Negative | 1.5 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Positive | 14.3 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Negative | 0.5 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Positive | 5.1 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16 Positive | 9.3 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 18 Positive | 3.9 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 45 Positive | 2.2 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive | 6.8 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other High Risk HPV Positive | 4.3 percentage of assays |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 18 Positive | 2.8 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive | 10.6 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16 Positive | 16.1 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other High Risk HPV Positive | 2.7 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 45 Positive | 2.5 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Negative | 0.3 percentage of assays |
| ASCUS >= 21 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Positive | 5.1 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Negative | 0.1 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Positive | 3.0 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16 Positive | 6.9 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 18 Positive | 2.6 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 45 Positive | 1.1 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive | 4.9 percentage of assays |
| NILM >= 30 Years Old | Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other High Risk HPV Positive | 2.2 percentage of assays |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Negative | 0.22 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Positive | 2.39 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16 Positive | 5.98 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 18 Positive | 2.86 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 45 Positive | 1.16 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive | 4.12 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other High Risk HPV Positive | 1.75 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Negative | 0.6 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 45 Positive | 2.42 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV High Risk Positive | 5.86 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other High Risk HPV Positive | 4.92 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16 Positive | 11.27 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive | 8.06 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 18 Positive | 4.41 Ratio |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 18 Positive | 1.28 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive | 5.35 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16 Positive | 8.6 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other High Risk HPV Positive | 1.26 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 45 Positive | 1.15 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Negative | 0.14 Ratio |
| ASCUS >= 21 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Positive | 2.41 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Negative | 0.33 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV High Risk Positive | 9.02 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16 Positive | 21.42 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 18 Positive | 7.64 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 45 Positive | 3.16 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive | 14.92 Ratio |
| NILM >= 30 Years Old | Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other High Risk HPV Positive | 6.49 Ratio |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | 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) | 98.5 percentage of participants |
| NILM >= 30 Years Old | 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) | 99.4 percentage of participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN2 or greater | 98.5 percentage of participants |
| ASCUS >= 21 Years Old | Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN3 or greater | 99.7 percentage of participants |
| NILM >= 30 Years Old | Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN2 or greater | 99.5 percentage of participants |
| NILM >= 30 Years Old | Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN3 or greater | 99.9 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | Non-reportable Rate of the BD Onclarity™ HPV Test | 0.24 percentage of participants |
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. | CIN2 or greater | 105 Participants |
| ASCUS >= 21 Years Old | Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. | CIN3 or greater | 35 Participants |
| NILM >= 30 Years Old | Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. | CIN2 or greater | 80 Participants |
| NILM >= 30 Years Old | Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. | CIN3 or greater | 46 Participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | 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) | 97.4 percentage of participants |
| NILM >= 30 Years Old | 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) | 92.0 percentage of participants |
Primary
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
Population: Data includes all participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN2 or greater | 14.3 percentage of participants |
| ASCUS >= 21 Years Old | Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN3 or greater | 5.1 percentage of participants |
| NILM >= 30 Years Old | Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN2 or greater | 5.1 percentage of participants |
| NILM >= 30 Years Old | Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). | CIN3 or greater | 3.0 percentage of participants |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV HR Positive vs HPV HR Negative | 9.33 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive vs HPV HR Negative | 14.57 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive vs 11 Other HR HPV Positive | 2.05 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other HR HPV Positive vs HPV HR Negative | 7.1 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | 11 Other HR HPV Positive vs HPV HR Negative | 7.88 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV HR Positive vs HPV HR Negative | 9.31 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive vs 11 Other HR HPV Positive | 1.59 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). | HPV 16/18/45 Positive vs HPV HR Negative | 12.56 ratio |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV HR Positive vs HPV HR Negative | 16.59 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive vs HPV HR Negative | 34.68 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive vs 11 Other HR HPV Positive | 3.91 ratio |
| ASCUS >= 21 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other HR HPV Positive vs HPV HR Negative | 8.87 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | 11 Other HR HPV Positive vs HPV HR Negative | 19.14 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV HR Positive vs HPV HR Negative | 26.36 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive vs 11 Other HR HPV Positive | 2.24 ratio |
| NILM >= 30 Years Old | Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). | HPV 16/18/45 Positive vs HPV HR Negative | 42.78 ratio |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | 85.7 percentage of participants |
| NILM >= 30 Years Old | Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | 44.4 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | 69.3 percentage of participants |
| NILM >= 30 Years Old | Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | 91.4 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | 64.1 percentage of participants |
| NILM >= 30 Years Old | Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater | 92.4 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASCUS >= 21 Years Old | Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | 62.0 percentage of participants |
| NILM >= 30 Years Old | Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater | 92.3 percentage of participants |