| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS) | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00085.7(77.8 to 91.1)
- OG00144.4(27.7 to 76.2)
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| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy | | OG001 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS) |
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| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS) | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | Data includes all participants with evaluable data. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | Ratio | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | Ratio | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | percentage of assays | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | percentage of assays | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | ratio | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | 95% Confidence Interval | ratio | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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| 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. | | Posted | | Number | | percentage of participants | | Up to 14 weeks | | | | ID | Title | Description |
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| OG000 | BD Onclarity™ HPV Assay on BD Viper™ LT | The LBC 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 (HC2) HPV and a polymerase chain reaction (PCR) sequencing test. Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or a random sampling of subjects with normal cytology and HPV negative test results. |
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| 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. | | Posted | | Count of Participants | | Participants | | Up to 14 weeks | | | | ID | Title | Description |
|---|
| OG000 | ASCUS >= 21 Years Old | Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS). | | OG001 | NILM >= 30 Years Old | Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy |
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