Diagnostic Accuracy of Artificial Intelligence Algorithm incorporated into MobileODT Enhanced Visual Assessment for triaging Screen Positive Women after Cervical Cancer Screening

Abstract Introduction : The goal of cervical cancer screening is to detect precancerous precursor lesions that can be treated in the preinvasive stage. Colposcopy is important for triaging of any abnormal cervical screening test. Scarcity of trained Colposcopists and colposcopy centres is a big hurdle to screening programs in lower and middle income countries. Objectives of the study: The objective was to assess the performance of the Artificial Intelligence based incorporated into the MobileODT Enhanced Visual Assessment (EVA Visual Check) against physician colposcopic diagnosis and the gold standard of histopathology. Material and Methods: A cross sectional observational study was conducted on women referred to our colposcopy clinic following an abnormal screening test. Colposcopic examination was performed by trained physicians using the mobile optical device technologies (ODT) Enhanced Visual Assessment (EVA) system and the images were saved. The physician colposcopic impression was recorded, biopsy performed if any acetowhite lesions were found. Images taken with the EVA system were uploaded on a cloud and analysed by the Visual Check algorithm. Correlation of Physician impression using the mobile ODT colposcope was compared with the Visual Check analysis. The sensitivity, specificity, positive predictive value, negative predictive value of physician’s impression and Visual Check analysis was compared with the final histopathological analysis or cytology . Cases with normal cytology and normal colposcopy did not undergo biopsy and these were considered normal. Result: A total of 2050 women were screened from January 2021 to September 2021.We studied 147 women, EVA Visual check had a Sensitivity of 86.8% (75-95), Specificity 28.7% (20-39), Positive Predictive Value of 40.7% (32-50) and negative predictive value of 79.4% (62-91) and diagnostic accuracy of 49.7% (41-58) for CIN 1+ lesions. EVA visual check has sensitivity 89.3% (72-98),specificity 26.1% (18-35), PPV 22.1% (15-31), NPV 91.2% (76-98) and diagnostic accuracy of 38.1% (30-46) for CIN 2 + lesions. Physician impression had a sensitivity of 86.8% (75-95), specificity of 81.9% (73-89) positive predictive value(PPV) 73.0% (60-83) negative predictive value (NPV) 91.7% (84-97) and diagnostic accuracy 83.7% (77-89) as compared to histopathological diagnosis of CIN1+ lesions and sensitivity of 92.9% (76-99) ,specificity of 68.9% ( 60-77%) ,positive predictive value (PPV) 41.3% (29-54) ,negative predictive value (NPV) 97.6% ( 92-100) and diagnostic accuracy 73.5% (66-80) as compared to histopathological diagnosis of CIN 2 + lesions as the gold standard Conclusion: Mobile ODT EVA colposcope with AI has sensitivity comparable to physician’s diagnosis while specificity ,PPV and NPV was less than that of physician diagnosis. It is valuable for triage of screen positive women for further management.