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BD Onclarity HPV Assay on the BD COR Instrument: Self-collected Vaginal Swabs Validation
Sponsor: Indiana University
Summary
This study is being done to help IU Health validate a new method for HPV testing using self-collected vaginal swab samples. Volunteers will collect two vaginal swabs during a single study visit. The test results from these samples will be compared to results from an already validated collection method to make sure the new testing process performs as expected. The information gathered will be used for laboratory validation and will not be used for medical care or reported back to participants.
Official title: BD Onclarity HPV Assay on the BD COR Instrument: a Performance Analysis Comparing Two Self-collected Vaginal Swabs From Volunteer IU Health Pathology Laboratory Team Members for Laboratory Validation
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-11-15
Completion Date
2026-12-15
Last Updated
2026-11-02
Healthy Volunteers
Yes
Conditions
Interventions
BD Cor OnClarity Self-Collection
Participants will self-collect two vaginal specimens during a single study visit, including one specimen using the currently validated in-office self-collection method and one specimen using the BD Onclarity At-Home Self-Collection Kit. Both specimens will undergo HPV testing using the BD Onclarity HPV Assay on the BD COR System. Results will be compared to evaluate the performance of at-home self-collected specimens and support laboratory validation prior to clinical implementation.
BD Onclarity HPV Assay
HPV testing of paired self-collected vaginal specimens using the BD Onclarity HPV Assay on the BD COR System to support laboratory validation of at-home self-collection for HPV screening.
Locations (1)
Indiana University, Department of Pathology
Indianapolis, Indiana, United States