Trials / Completed
CompletedNCT01944722
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33,858 (actual)
- Sponsor
- Becton, Dickinson and Company · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BD 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. |
| PROCEDURE | Colposcopy | 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. |
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2013-09-18
- Last updated
- 2018-06-12
- Results posted
- 2018-04-18
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01944722. Inclusion in this directory is not an endorsement.