Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 2/2/2018 |
| Start Date: | November 2016 |
| End Date: | May 2017 |
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 Liquid-based cytology media
diluted in HPV diluent to adjudicated histology results from biopsy.
Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media
diluted in HPV diluent to adjudicated histology results from biopsy.
Inclusion Criteria:
- Females who are greater than or equal to 21 years of age,
- Subjects with a ASCUS (Atypical Squamous Cells - Undetermined Significance) cytology
result,
- Females who provide informed consent
Exclusion Criteria:
- Known pregnant
- Prior complete or partial hysterectomy involving removal of cervix
- Conization, LEEP, cervical laser surgery or cryosurgery on the cervix has been
performed in the last twelve months
- Colposcopy clinic referral patients
We found this trial at
12
sites
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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