Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Becton, Dickinson and Company

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

BD Onclarity™ HPV Assay (Viral DNA Test)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: BD HPV assay on Viper LTExperimental Treatment1 Intervention

The BD HPV specimen will be tested with the BD HPV assay on the 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. Device: BD HPV assay on Viper LT The BD HPV specimen will be tested with the BD HPV assay on the 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. Colposcopy/biopsy will be performed on all subjects.