Clinical Evaluation of AI100 with Shonit™ versus Manual Microscopy

OBJECTIVES: Peripheral blood smear (PBS) is an essential diagnostic test in current medical practice. AI100 with Shonit™ (AI100) is an automatic cell-locating device intended for white blood cell (WBC) differential count, red blood cell (RBC), and platelet morphology precharacterization. We report a multicenter study evaluating the clinical performance of the AI100 with Shonit™ (combined performance after qualified reviewer verification) in PBS analysis, establishing its equivalence to manual microscopy for diagnostic purposes. MATERIALS AND METHODS: A retrospective multisite study was conducted at four sites (three in India and one in USA) from August 2021 to January 2023. A total of 882 samples were analyzed by two qualified reviewers in each site independently using manual microscopy and AI100 with Shonit™. The post-review results were compared between AI100 and manual microscopy. RESULTS: The overall agreement, sensitivity, and specificity for WBC abnormality are 95.03%, 92.68% and 95.41%, respectively. The overall agreement for RBC anisocytosis and poikilocytosis is 94.7% and 92.1%, respectively. For platelet morphology, the overall agreement, sensitivity, and specificity were 96.8%, 97.9%, and 94.6%, respectively. The repeatability and reproducibility of AI100 with Shonit ™ were also evaluated. CONCLUSION: The performance comparison study results demonstrate that the AI100 with Shonit™ is substantially equivalent to manual microscopy.