HPV Self Collection
HPV Self-Collection Testing with the BD Onclarity™ HPV Assay
Express Lab now offers physician offices the ability to expand cervical cancer screening through self-collected HPV testing validated on the BD Onclarity™ HPV Assay. This option provides a clinically reliable solution for patients who are underserved or reluctant to undergo in-office collection due to embarrassment, cultural factors, or limited access to care.
Clinical Validation
- Equivalent sensitivity
The BD Onclarity™ HPV Assay demonstrates equivalent diagnostic accuracy for detecting CIN2+ lesions in both self-collected and clinician-collected vaginal samples. - Lowest invalid rate
In comparative studies of multiple PCR-based HPV assays, the BD Onclarity™ HPV Assay produced the lowest proportion of invalid results from self-collected samples. This reliability reduces repeat testing and enhances efficiency in patient management.
Streamlined Workflow
- A vaginal sample is self-collected by the patient, at your clinic, using an approved device.
- The sample is transported dry to Express Lab within 30 days of collection at 2–30 ºC.
- Upon arrival, the specimen is transferred into a BD Onclarity™ HPV Self Collection Diluent Tube and can be stored for up to 15 days at -20–30 ºC.
- The sample is tested on the BD Onclarity™ HPV Assay using either the BD Viper™ LT System or the BD COR™ System.
- Results are reported directly to the ordering provider for incorporation into the patient’s care plan.
Benefits for Physician Practices
- Extends screening access to women who may decline or delay clinician-collected samples.
- Provides confidence in diagnostic accuracy with validated assay performance.
- Reduces barriers to screening participation, supporting earlier detection and improved outcomes.
By integrating self-collection with the BD Onclarity™ HPV Assay into routine practice, Express Lab helps physicians increase screening rates, ensure reliable results, and deliver patient-centered solutions in cervical cancer prevention.