Clinical evaluation of a portable pocket colposcope for cervical cancer screening in the United States, Perú, and Tanzania

Abstract

Cervical cancer is the second leading cause of cancer related deaths for women worldwide, despite being both preventable and treatable if detected early enough. The burden of disease persists in part due to a lack of access to early diagnostics and the fact that a significant proportion of women do not return for follow-up care. To address this need, we developed a low-cost, portable Pocket colposcope that can be used in remote settings for cervical cancer screening and prevention. We evaluated whether the Pocket colposcope performs comparably to the standard-of-care colposcope in Durham, North Carolina, Lima, Perú, and Moshi, Tanzania. Concordant image pairs obtained from this device and the current standard imaging was sent to physician experts from high, middle, and low-income countries. They were blinded as to diagnosis, device, and peer response. Each image was critically evaluated for quality and presumptive findings and compared. Corresponding pathology was obtained for each patient. Physician interpretation agreed 76.8% of the time between the Pocket colposcope and standard-of-care colposcope. Physician interpretation agreed with pathology 59.4% and 63.0% for the Pocket and standard-of-care colposcopes, respectively. The primary outcome of this study was to show reasonable concordance between the Pocket colposcope and state of the art imaging in terms of individual examiners, pathologic diagnosis, and image quality. In all areas the Pocket colposcope showed comparable results to country-specific standard-of-care screening.