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

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.

Description

Eligibility

Age range

18+ years

Sex

Female

Healthy volunteers

Yes

Interventions

• Device
  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.

• Diagnostic Test
  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.

Location