Artificial intelligence-assisted early screening of acute promyelocytic leukaemia in blood smears: a prospective evaluation of MC-100i.

Objectives: Identification of abnormal promyelocytes is crucial for early diagnosis of Acute promyelocytic leukaemia (APL) and for reducing the early mortality rate of APL patients, which can be achieved by microscopic blood smear observation. However, microscopic observation has shortcomings, including interobserver variability and training difficulty. This is the first study evaluating the performance of MC-100i, an artificial intelligence (AI)-based digital morphology analyser, in identifying abnormal promyelocytes in blood smears and thus assisting in the early screening of APL. Methods: One hundred ninety-two patients suspected of having APL were enrolled prospectively. The precision, accuracy, consistency with manual classification and turnaround time of MC-100i were studied in detail. Results: The precision of MC-100i in identifying all cell types was acceptable. MC-100i had excellent performance in preclassifying normal cell types, but its sensitivities for identifying blasts, abnormal promyelocytes, promyelocytes and neutrophilic myelocytes were relatively low, respectively. The Passing-Bablok and Bland-Altman tests revealed that the preclassification abnormal promyelocyte percentage obtained with MC-100i was proportionally different from that obtained with manual classification, whereas the postclassification and manual classification results were consistent. The clinical sensitivity and specificity for the early screening of APL were 95.8% and 100.0%, respectively. The turnaround and classification times were significantly shorter with the use of MC-100i for both the technologist and the experienced expert. Conclusions: MC-100i is an effective tool for identifying abnormal promyelocytes in blood smears and assisting in the early screening of APL. It is useful when experienced morphological experts or advanced tests are not available.