Trial Outcomes & Findings for Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens (NCT NCT01944722)
NCT ID: NCT01944722
Last Updated: 2018-06-12
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33858 participants
Primary outcome timeframe
Up to 14 weeks
Results posted on
2018-06-12
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
33858
|
|
Overall Study
COMPLETED
|
24343
|
|
Overall Study
NOT COMPLETED
|
9515
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Didn't meet Inclusion/Exclusion Criteria
|
171
|
|
Overall Study
Specimen Shipping Issues
|
34
|
|
Overall Study
Improper Storage/Transport
|
5
|
|
Overall Study
Insufficient Volume for Test
|
1
|
|
Overall Study
Missing Specimens
|
3
|
|
Overall Study
Specimens Mislabeled
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
NILM Subjects <30 years old
|
8106
|
|
Overall Study
Unsatisfactory Cytology Result
|
63
|
|
Overall Study
>ASCUS Cytology
|
1122
|
Baseline Characteristics
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Baseline characteristics by cohort
| Measure |
ASCUS Aged 21 Years and Older
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS).
|
NILM Aged 30 Years and Older
n=22383 Participants
Participants aged 30 years and older and having cytology results that are negative for intraepithelial lesions or malignancy (NILM).
|
Total
n=24343 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
43.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1960 Participants
n=5 Participants
|
22383 Participants
n=7 Participants
|
24343 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
303 Participants
n=5 Participants
|
4592 Participants
n=7 Participants
|
4895 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1657 Participants
n=5 Participants
|
17789 Participants
n=7 Participants
|
19446 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
7 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
336 Participants
n=7 Participants
|
356 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
459 Participants
n=5 Participants
|
3722 Participants
n=7 Participants
|
4181 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1446 Participants
n=5 Participants
|
17988 Participants
n=7 Participants
|
19434 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1960 Participants
n=5 Participants
|
22383 Participants
n=7 Participants
|
24343 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 weeksSensitivity 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 77.8 to 91.1
|
44.4 percentage of participants
Interval 27.7 to 76.2
|
PRIMARY outcome
Timeframe: Up to 14 weeksSensitivity 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=22383 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=1960 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 42.0 to 100.0
|
91.4 percentage of participants
Interval 77.6 to 97.0
|
PRIMARY outcome
Timeframe: Up to 14 weeksSpecificity 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 61.7 to 66.5
|
92.4 percentage of participants
Interval 92.1 to 92.8
|
PRIMARY outcome
Timeframe: Up to 14 weeksSpecificity 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 59.6 to 64.4
|
92.3 percentage of participants
Interval 92.0 to 92.7
|
PRIMARY outcome
Timeframe: Up to 14 weeksPopulation: Data includes all participants with evaluable data.
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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 13.0 to 15.5
|
5.1 percentage of participants
Interval 3.9 to 6.3
|
|
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
Interval 4.3 to 5.6
|
3.0 percentage of participants
Interval 2.1 to 3.9
|
PRIMARY outcome
Timeframe: Up to 14 weeksNegative 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 97.6 to 99.0
|
99.5 percentage of participants
Interval 99.0 to 99.9
|
|
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
Interval 99.2 to 99.9
|
99.9 percentage of participants
Interval 99.7 to 100.0
|
PRIMARY outcome
Timeframe: Up to 14 weeksThe 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
HPV High Risk Positive
|
2.39 Ratio
Interval 2.13 to 2.63
|
5.86 Ratio
Interval 3.63 to 10.11
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
HPV 16 Positive
|
5.98 Ratio
Interval 4.15 to 8.42
|
11.27 Ratio
Interval 5.92 to 21.08
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
HPV 18 Positive
|
2.86 Ratio
Interval 1.24 to 6.45
|
4.41 Ratio
Interval 0.0 to 11.9
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
HPV 45 Positive
|
1.16 Ratio
Interval 0.38 to 3.42
|
2.42 Ratio
Interval 0.0 to 7.18
|
|
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
Interval 3.07 to 5.38
|
8.06 Ratio
Interval 4.48 to 14.46
|
|
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
Interval 1.38 to 2.15
|
4.92 Ratio
Interval 3.0 to 8.51
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
HPV High Risk Negative
|
0.22 Ratio
Interval 0.14 to 0.35
|
0.6 Ratio
Interval 0.26 to 0.78
|
PRIMARY outcome
Timeframe: Up to 14 weeksThe 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
HPV High Risk Positive
|
2.41 Ratio
Interval 2.03 to 2.64
|
9.02 Ratio
Interval 5.48 to 13.21
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
HPV 16 Positive
|
8.6 Ratio
Interval 5.69 to 12.08
|
21.42 Ratio
Interval 11.1 to 38.33
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
HPV 18 Positive
|
1.28 Ratio
Interval 0.22 to 6.74
|
7.64 Ratio
Interval 0.0 to 22.64
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
HPV 45 Positive
|
1.15 Ratio
Interval 0.2 to 6.03
|
3.16 Ratio
Interval 0.0 to 12.28
|
|
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
Interval 3.72 to 7.07
|
14.92 Ratio
Interval 8.19 to 25.88
|
|
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
Interval 0.76 to 1.88
|
6.49 Ratio
Interval 3.59 to 10.98
|
|
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
HPV High Risk Negative
|
0.14 Ratio
Interval 0.05 to 0.36
|
0.33 Ratio
Interval 0.0 to 0.63
|
PRIMARY outcome
Timeframe: Up to 14 weeksThe 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 13.0 to 15.5
|
5.1 percentage of assays
Interval 3.9 to 6.3
|
|
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
Interval 22.5 to 37.0
|
9.3 percentage of assays
Interval 5.5 to 13.7
|
|
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
Interval 7.9 to 31.1
|
3.9 percentage of assays
Interval 0.0 to 8.4
|
|
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
Interval 2.6 to 19.3
|
2.2 percentage of assays
Interval 0.0 to 5.4
|
|
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
Interval 17.7 to 27.3
|
6.8 percentage of assays
Interval 4.4 to 9.7
|
|
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
Interval 8.8 to 13.1
|
4.3 percentage of assays
Interval 3.1 to 5.5
|
|
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
Interval 1.0 to 2.4
|
0.5 percentage of assays
Interval 0.1 to 1.0
|
PRIMARY outcome
Timeframe: Up to 14 weeksThe 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 4.3 to 5.6
|
3.0 percentage of assays
Interval 2.1 to 3.9
|
|
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
Interval 11.2 to 21.2
|
6.9 percentage of assays
Interval 3.9 to 9.9
|
|
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
Interval 0.5 to 13.0
|
2.6 percentage of assays
Interval 0.0 to 6.4
|
|
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
Interval 0.4 to 11.8
|
1.1 percentage of assays
Interval 0.2 to 3.4
|
|
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
Interval 7.7 to 13.6
|
4.9 percentage of assays
Interval 3.0 to 6.9
|
|
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
Interval 1.7 to 4.0
|
2.2 percentage of assays
Interval 1.4 to 3.2
|
|
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
Interval 0.1 to 0.8
|
0.1 percentage of assays
Interval 0.0 to 0.3
|
PRIMARY outcome
Timeframe: Up to 14 weeksRelative 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 5.49 to 15.88
|
9.31 ratio
Interval 4.5 to 38.03
|
|
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
Interval 8.3 to 25.52
|
12.56 ratio
Interval 5.62 to 49.57
|
|
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
Interval 1.41 to 2.98
|
1.59 ratio
Interval 0.97 to 2.57
|
|
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
Interval 4.05 to 12.45
|
7.88 ratio
Interval 3.81 to 32.06
|
PRIMARY outcome
Timeframe: Up to 14 weeksRelative 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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 5.42 to 50.86
|
26.36 ratio
Interval 8.51 to 9999999.0
|
|
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
Interval 11.09 to 108.53
|
42.78 ratio
Interval 13.16 to 9999999.0
|
|
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
Interval 1.98 to 7.73
|
2.24 ratio
Interval 1.22 to 4.05
|
|
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
Interval 2.7 to 29.14
|
19.14 ratio
Interval 5.83 to 9999999.0
|
PRIMARY outcome
Timeframe: Up to 14 weeksPositive 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 95.5 to 98.6
|
92.0 percentage of participants
Interval 89.8 to 94.0
|
PRIMARY outcome
Timeframe: Up to 14 weeksNegative 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).
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
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
Interval 97.1 to 99.2
|
99.4 percentage of participants
Interval 99.3 to 99.6
|
PRIMARY outcome
Timeframe: Up to 14 weeksNon-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.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=33570 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
Non-reportable Rate of the BD Onclarity™ HPV Test
|
0.24 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to 14 weeksPrevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.
Outcome measures
| Measure |
ASCUS >= 21 Years Old
n=1960 Participants
Participants aged 21 years and older and having atypical squamous cells of undetermined significance (ASCUS)
|
NILM >= 30 Years Old
n=22383 Participants
Participants aged 30 years and older and having cytology results negative for intraepithelial lesions or malignancy
|
|---|---|---|
|
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
CIN2 or greater
|
105 Participants
|
80 Participants
|
|
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
CIN3 or greater
|
35 Participants
|
46 Participants
|
Adverse Events
BD HPV Onclarity™ Assay on BD Viper™ LT
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
BD HPV Onclarity™ Assay on BD Viper™ LT
n=33858 participants at risk
Subjects tested with the BD HPV Onclarity™ assay on the BD Viper™ LT instrument.
|
|---|---|
|
Infections and infestations
Diverticultitis and Sepsis
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma in situ - cervical
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Surgical and medical procedures
Myomectomy
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Injury, poisoning and procedural complications
Prescription overdose leading to death
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage 3 Breast Infiltrating Ductal Carcinoma
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Carcinoma
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of vulva, in situ
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Breast Malignancy
|
0.00%
1/33858 • Number of events 1 • Adverse events were collected throughout the course of the study (up to 30 months).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place