Development of an HPV 16 rapid test founded in user-centered design with primary care clinicians

Despite effective screening modalities, cervical cancer remains a leading cause of cancer-related death among women in the United States aged 20 to 39 years old, and incidence is rising in women aged 30-44 years old. Up to 25% of patients who are screened for cervical cancer by testing for human papillomavirus (HPV) do not receive necessary follow-up care with current laboratory-based testing. Applying a user-centered design approach, we surveyed and interviewed practicing clinicians to establish the use case, value proposition, and user requirements of a cervical cancer screening test for use in Indiana, USA. Insights from these stakeholders directly informed design specifications for a point-of-care HPV test capable of providing same-visit results to improve patient follow-up and retention. Guided by these requirements, we designed an isothermal nucleic acid amplification platform suitable for outpatient clinics. The test accepts swabbed endocervical cells, amplifies HPV16 L1 DNA via recombinase polymerase amplification, and provides results within 40 minutes on a lateral flow assay. Further, the test achieves a clinically relevant limit of detection of 1000 HPV 16 copies per reaction and verifies swabbing technique and test operation with a sample adequacy control. The test operation was designed for a minimally-trained user and decreases time-sensitive steps that would interfere with clinical flow. By integrating clinician input to inform development decisions, our device is uniquely tailored to meet the context-specific needs of primary care clinics. This work exemplifies how user-centered design can yield novel diagnostic technologies with greater clinical impact and adoption potential.