Preliminary Evaluation of miLab™ BCM, an AI-Powered Digital CBC and Morphology Analyzer: Focus on Method Comparison

Abstract

A method-comparison study (CLSI EP09-A3, n=301) benchmarked miLab™ BCM against the Sysmex XN-series across CBC and WBC differential parameters. miLab™ BCM demonstrated high concordance for core CBC indices and outperformed Sysmex in IG detection vs. manual differential (r=0.957 vs. 0.791), with excellent blast agreement (r=0.976). Operating from a single-use 5 µL cartridge with no external reagents, results support deployment as a POCT solution for decentralized and resource-limited settings.

Figure 5. Representative cell morphologies on miLab™ BCM. Left to right: Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil, Immature granulocyte (IG), Blast (two examples), Platelets Clumping. Images are crops from the digital viewer of Wright-Giemsa stained, cartridge-prepared smears.

Key Highlights

• miLab™ BCM showed high concordance with the Sysmex XN-series across core CBC parameters (WBC r=0.988, RBC r=0.975, PLT r=0.975).
• IG detection against the manual differential was superior to Sysmex (r=0.957 vs. 0.791), and blast detection showed excellent agreement (r=0.976) — a parameter Sysmex does not report.
• The sealed, single-use 5 µL cartridge requires no external reagents and eliminates operator-dependent handling steps.
• The entire workflow — CBC, smear preparation, staining, imaging, and AI-assisted review — is completed in a single automated run.

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