HPV RAPID DIAGNOSTIC TEST DEVELOPMENT THROUGH USER-CENTERED DESIGN

Almost every case of cervical cancer in the United States is medically preventable with vaccination and proper screening, yet many Americans are insufficiently screened. Over 12 thousand American women suffered from cervical cancer in 2018¹ causing 4 thousand deaths, with over a third in women who had never received a routine screening test².

New, sensitive testing techniques for cervical cancer screening are facilitating HPV testing without evaluating the cells collected in the sample by eye. This opens the door to new, accessible methods of screening such as rapid testing in clinic and at home, self-sampling, and mail-in testing. As cervical cancer morbidity and mortality is largely a result of healthcare inequities, these methods may have a significant impact on cervical cancer outcomes.

The goal of this project is to create a proof-of-concept, sample-to-answer rapid test to be used for cervical cancer screening in Indiana outpatient clinics. We began the project by conducting interviews and a survey to explore Indiana clinician perspectives on cervical screening methods such as self-sampling, rapid testing, and home-based screening. Clinicians preferred in-clinic testing with same-visit results, in the hopes that face-to-face explanation of results and scheduling follow-up care in person would improve patient retention for these important follow-up tests. To create such a test, we augmented an isothermal nucleic acid amplification method that copies 13 of the 14 high-risk human papillomavirus (hrHPV) types with an endogenous b-globin sample control and a simple colorimetric lateral flow strip (LFS) readout. When tested with HPV 16 the assay achieved a limit of detection of 1000 HPV copies per reaction, which would detect endocervical samples deemed ‘sufficient’ by clinical guidelines. It also performs in endocervical cells using methods and equipment that could be implemented in an outpatient clinic. The final test accepts swabs or brushes of endocervical cells, lyses them in 5 minutes, copies the target DNA and a sample adequacy control, and delivers the readout within 40 minutes on an LFS readout. Future directions for this assay include soliciting feedback from clinicians and other stakeholders about the prototype developed, adapting the assay to interferents of clinical endocervical samples, and adding probes for other HPV types, such as HPV 18 and eventually the other hrHPV types.