Objective
Barriers to cervical cancer screening in low resource settings include lack of accessible high quality services, high cost, and the need for multiple visits. To address these challenges, we developed a low cost intra-vaginal optical cervical imaging device, the Point of Care Tampon (POCkeT) colposcope, and evaluated whether its performance is comparable to a standard-of-care colposcope.
Methods
There were two protocols, which included 44 and 18 patients respectively. For the first protocol, white light cervical images were collected in vivo, blinded by device, and sent electronically to 8 physicians from high, middle and low income countries. For the second protocol, green light images were also collected and sent electronically to the highest performing physician from the first protocol who has experience in both a high and low income country. For each image, physicians completed a survey assessing cervix characteristics and severity of precancerous lesions. Corresponding pathology was obtained for all image pairs.
Results
For the first protocol, average percent agreement between devices was 70% across all physicians. POCkeT and standard-of-care colposcope images had 37% and 51% percent agreement respectively with pathology for high-grade squamous intraepithelial lesions (HSILs). Investigation of HSIL POCkeT images revealed decreased visibility of vascularization and lack of contrast in lesion margins. After changes were made for the second protocol, the two devices achieved similar agreement to pathology for HSIL lesions (55%).
Conclusions
Based on the exploratory study, physician interpretation of cervix images acquired using a portable, low cost, POCkeT colposcope was comparable to a standard-of-care colposcope.