Diagnostic Translational Considerations for Global Health Settings: Portable Detection of Human Papillomavirus for Cervical Cancer Screening in India.

Abstract

Purpose: Translation of diagnostic technology developed at the laboratory bench involves iterations of user feedback and design modifications. Learning about translational requirements early in the design process facilitates the development of feasible prototypes that have a better likelihood of implementation in global health settings. During our development of a portable system to detect human papillomavirus (HPV) for cervical cancer screening in India, we encountered and solved issues related to research translation. We report our findings to help others deploying diagnostic technology for global health.

Materials and methods: We designed a point-of-care system to process patient samples and diagnose HPV infection in the cervix. We continually shipped components of the system from the United States to our collaborating team in India to assess component condition and usability at the local site. We simultaneously developed HPV isothermal amplification assays that were fit for purpose. Cervical brush samples were used in our portable system for functional validation.

Results: We found ideal transport methods to ensure component quality and reagent stability through the international shipment chain. Portable systems should be designed as simple as possible for correct usage at the local testing site. Usability tests drove our design improvements from 28% to 93% success rates. We demonstrated proof-of-concept functionality of our portable system for 13 cervical brush samples on-site, with a sensitivity of 100% and specificity of 88.9%.

Conclusion: Issues related to technology transfer for global health settings manifest during distribution and deployment of prototypes. We identified several issues during our synergistic design process and report recommendations on the basis of our experience.