Clinical trial · Observational
European Clinical Evaluation of the BD HPV Assay on the BD Viper LT System
NCT01671462CI-TRIAL-00013815completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from SurePath media diluted in HPV diluent (pre-quot and/or residual), PreservCyt media diluted in HPV diluent (pre-quot and/or residual) and a BD cervical brush in BD transport medium to reference histology results from biopsy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BD HPV assay on Viper LT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Sensitivity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
- timeFrame
- Nine months
- description
- Sensitivity is calculated: Number of subjects with positive BD HPV test and with histology results of CIN2 or greater divided by the total number of subjects with histology results of CIN2 or greater
- measure
- Specificity of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
- timeFrame
- Nine months
- description
- Specificity is calculated: Number of subjects with a negative BD HPV test and with histology results of less than CIN2 divided by the total number of subjects with histology results of less than CIN2.
- measure
- Positive Predictive Value (PPV) of the BD HPV Assay with 95% confidence intervals for detecting cervical disease as defined by Cervical Intraepithelial Neoplasia (CIN2) or higher.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Referred to follow up due to one or more abnormal Pap or an HPV infection * Subjects who have provided informed consent * Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines. Exclusion Criteria: * Known to be pregnant * With prior complete or partial hysterectomy involving removal of cervix * Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry- this includes acetic acid, iodine, spermicide, douche, anti-fungal meds. * Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed.
References
Publications (2)
- DERIVEDEjegod DM, Junge J, Franzmann M, Kirschner B, Bottari F, Sideri M, Sandri MT, Bonde J. Clinical and analytical performance of the BD Onclarity HPV assay for detection of CIN2+ lesions on SurePath samples. Papillomavirus Res. 2016 Dec;2:31-37. doi: 10.1016/j.pvr.2016.01.003. Epub 2016 Mar 2. PMID 29074183
- DERIVEDEjegod DM, Rebolj M, Bonde J. Comparison of analytical and clinical performance of CLART HPV2 genotyping assay to Linear Array and Hybrid Capture 2: a split-sample study. BMC Cancer. 2015 Apr 2;15:216. doi: 10.1186/s12885-015-1223-z. PMID 25886410