Lateral Flow HPV Test for Cervical Cancer Screening in Low-Resource Settings
Agency: Boston University Center for Innovation in POC Technologies for the Future of Cancer (NIH U54 Program)
Collaborators: Rebecca Richards-Kortum (Rice), Kathleen Schmeler (UT MD Anderson), Philip Castle (Albert Einstein College of Medicine)
Cervical cancer is a leading cause of cancer death among women in the developing world. Screening programs to detect HPV, the cause of cervical cancer, have reduced the incidence and mortality of cervical cancer in the developed world. However, these screening programs are not appropriate for low resource settings due to their high cost and need for infrastructure and trained personnel. To enable global cervical cancer prevention efforts, we propose to develop an inexpensive (<$2), robust, and rapid (<60 min.) HPV DNA test that does not require lab equipment and is as simple to use as a rapid HIV test. Our approach is based on a sensitive lateral flow test to detect high risk HPV DNA. We hypothesize that our lateral flow HPV DNA test can be performed by community health care workers with similar sensitivity and specificity to commercially available hybrid capture HPV DNA tests. At <$2/test, our approach has the potential to enable sustainable and scalable cervical cancer screening and prevention for all women.
In this one-year pilot grant, we propose to: (1) Develop and optimize a lateral flow test to detect HPV DNA from cervical cytology specimens; (2) Characterize the performance of our lateral flow HPV test in a lab setting; and (3) Assess usability of our lateral flow HPV DNA test by nurses and community health workers in Malawi. The proposed work will allow us to optimize sample preparation methods, fully characterize test performance in the lab and assess usability of the device in a point-of-care setting. Results of this work will enable us to efficiently identify and resolve any in-field challenges before proceeding to subsequent field evaluation studies.