AI-assisted digital peripheral blood morphology multicenter randomized paired method clinical validation study
摘要
Peripheral blood smear examination is labor-intensive and operator-dependent. We conducted a multicenter, prospective, randomized paired study of an AI-assisted digital morphology system in routine practice. Among 1570 analyzed smears from three centers, AI-assisted analysis outperformed manual microscopy across 15 nucleated cell categories, including improved screening for acute promyelocytic leukemia through detection of abnormal promyelocytes (F1 score 0.794 [95% CI, 0.667–0.892] vs 0.658 [0.508–0.767]). AI assistance also improved diagnostic performance across most erythrocyte morphology categories, including better detection of teardrop cells, a morphologic clue relevant to myelofibrosis (F1 score 0.306 [0.233–0.374] vs 0.261 [0.190–0.323]). Platelet estimation was more accurate with AI assistance, with lower absolute mean deviation from flow cytometry (2.05 vs 14.08 × 109/L). AI assistance increased technician efficiency by approximately 60%, supporting its potential role in improving the consistency and efficiency of morphology reporting for the evaluated cell categories in routine smear-review workflows.