N/A
Completed N=33,858
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
Source: ClinicalTrials.gov NCT01944722 ↗Enrolled (actual)
33,858
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater — 85.7; 44.4 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater |
85.7; 44.4 | — |
| PRIMARY 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; 91.4 | — |
| PRIMARY Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater |
64.1; 92.4 | — |
| PRIMARY Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater |
62.0; 92.3 | — |
| PRIMARY Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). |
14.3; 5.1; 5.1; 3.0 | — |
| PRIMARY Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN). |
98.5; 99.5; 99.7; 99.9 | — |
| PRIMARY Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). |
2.39; 5.86; 5.98; 11.27; 2.86; 4.41 | — |
| PRIMARY Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). |
2.41; 9.02; 8.6; 21.42; 1.28; 7.64 | — |
| PRIMARY Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). |
14.3; 5.1; 29.5; 9.3; 16.7; 3.9 | — |
| PRIMARY Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). |
5.1; 3.0; 16.1; 6.9; 2.8; 2.6 | — |
| PRIMARY Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater). |
9.33; 9.31; 14.57; 12.56; 2.05; 1.59 | — |
| PRIMARY Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater). |
16.59; 26.36; 34.68; 42.78; 3.91; 2.24 | — |
| 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) |
97.4; 92.0 | — |
| 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) |
98.5; 99.4 | — |
| PRIMARY Non-reportable Rate of the BD Onclarity™ HPV Test |
0.24 | — |
| PRIMARY Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category. |
105; 80; 35; 46 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01944722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.