Performance Evaluation of CBC Analysis on miLab™ BCM: A Comparative Study with Sysmex XN Hematology Analyzer
The miLab™ BCM is a clinically viable, AI-assisted point-of-care solution that delivers reliable CBC and 6-part differential results from just 5 µL of blood, streamlining workflow for diverse clinical settings, including neonates.
ISLH 2026
|April 18, 2026
|CY Bae, et al.
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Abstract
Analyzing 102 whole blood samples, including neonatal specimens, the miLab™ BCM, utilizing a 5 µL sample for its automated CBC and 6-part differential workflow, demonstrated strong analytical correlation and agreement with the Sysmex XN-series (e.g., WBC R=0.981, IG R=0.852), confirming its high utility as a reliable, clinically viable point-of-care solution.
| N | Correlation coefficient (R) | Slope (95% CI) | Intercept (95% CI) | Mean bias (LLoA, ULoA) | |
|---|---|---|---|---|---|
| WBC (10³/µL) | 102 | 0.981 | 0.989 (0.927, 1.052) | 0.305 (-0.033, 0.694) | 0.443 (-12.722, 13.608) |
| RBC (10⁶/µL) | 102 | 0.956 | 0.948 (0.897, 1.019) | 0.246 (-0.012, 0.462) | 0.045 (-0.567, 0.657) |
| PLT (10³/µL) | 102 | 0.979 | 0.925 (0.883, 0.969) | 5.274 (-0.651, 10.288) | -13.039 (-86.405, 60.326) |
| HGB (g/dL) | 102 | 0.959 | 0.980 (0.920, 1.050) | 0.439 (-0.216, 1.134) | 0.210 (-1.579, 1.999) |
| HCT (%) | 102 | 0.955 | 0.989 (0.947, 1.042) | 0.521 (-1.149, 2.027) | 0.027 (-5.528, 5.582) |
| RDW-CV (%) | 90 | 0.819 | 0.712 (0.596, 0.827) | 4.081 (2.353, 5.637) | -0.444 (-3.394, 2.505) |
| Neutrophil % | 97 | 0.926 | 1.015 (0.970, 1.091) | 0.249 (-2.192, 4.079) | 1.270 (-17.166, 19.706) |
| Lymphocyte % | 97 | 0.857 | 0.996 (0.949, 1.056) | -1.901 (-3.667, -0.235) | 0.171 (-23.821, 24.162) |
| Monocyte % | 97 | 0.771 | 0.946 (0.815, 1.103) | -0.926 (-2.267, 0.033) | -3.519 (-26.559, 19.522) |
| Eosinophil % | 97 | 0.911 | 0.951 (0.784, 1.066) | -0.007 (-0.106, 0.000) | -0.200 (-2.690, 2.290) |
| Basophil % | 97 | 0.700 | 3.069 (-8.404, 14.542) | -0.614 (-4.877, 3.650) | 0.263 (-1.880, 2.406) |
| IG % | 97 | 0.852 | 0.876 (0.642, 1.111) | -0.763 (-1.275, -0.252) | -1.155 (-7.168, 4.858) |
Table 1. Method Comparison and Bias Analysis of the miLab™ BCM vs. Sysmex XN-series (N=102)
Key Highlights
- The miLab™ BCM showed strong correlation with the Sysmex XN for CBC and 6-part differential parameters.
- Reliable results were confirmed for diverse patient cohorts, especially neonatal specimens.
- It could be a practical point-of-care solution requiring only 5 µL of whole blood for neonatal specimens.
- The analyzer streamlines workflow with AI-assisted digital imaging and a 'single-run' process.
Keywords
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