BD Onclarity HPV Assay for Human Papillomavirus
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for healthy volunteers willing to provide two self-collected vaginal swab samples in a single visit. There are no specific inclusion or exclusion criteria listed, but participants should not have any health issues that would prevent safe sample collection.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing if a new HPV test using self-collected vaginal swabs works as well as the standard method. Volunteers collect their own samples, which are then compared to results from an established process.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will provide two self-collected vaginal specimens during a single study encounter: 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 be tested using the BD Onclarity HPV Assay on the BD COR System. Results from the paired specimens will be compared to support laboratory validation of at-home self-collected HPV testing prior to clinical implementation at IU Health.
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Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
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