Validation of AI-assisted ThinPrep® Pap test screening using the Genius^TM Digital Diagnostics System

Advances in whole-slide imaging and artificial intelligence present opportunities for improvement in Pap test screening. To date, there have been limited studies published regarding how best to validate newer AI-based digital systems for screening Pap tests in clinical practice. In this study, we validated the Genius™ Digital Diagnostics System (Hologic) by comparing the performance to traditional manual light microscopic diagnosis of ThinPrep® Pap test slides. A total of 319 ThinPrep® Pap test cases were prospectively assessed by six cytologists and three cytopathologists by light microscopy and digital evaluation and the results compared to the original ground truth Pap test diagnosis. Concordance with the original diagnosis was significantly different by digital and manual light microscopy review when comparing across: (i) exact Bethesda System diagnostic categories (62.1% vs 55.8%, respectively, p = 0.014), (ii) condensed diagnostic categories (76.8% vs 71.5%, respectively, p = 0.027), and (iii) condensed diagnoses based on clinical management (71.5% vs 65.2%, respectively, p = 0.017). Time to evaluate cases was shorter for digital (M = 3.2 min, SD = 2.2) compared to manual (M = 5.9 min, SD = 3.1) review (t(352) = 19.44, p < 0.001, Cohen's d = 1.035, 95% CI [0.905, 1.164]). Not only did our validation study demonstrate that AI-based digital Pap test evaluation had improved diagnostic accuracy and reduced screening time compared to light microscopy, but that participants reported a positive experience using this system.