Performance of automated digital cell imaging analyzer Sysmex DI-60

Area of Science:

• Hematology
• Clinical Pathology
• Medical Laboratory Technology

Background:

• The Sysmex DI-60 is a new automated digital cell imaging analyzer.
• Evaluating its performance against established methods is crucial for clinical adoption.

Purpose of the Study:

• To assess the diagnostic performance of the Sysmex DI-60 analyzer.
• To compare its accuracy in white blood cell (WBC) differentials, red blood cell (RBC) classification, and platelet (PLT) estimation against the Sysmex XN analyzer and manual counts.

Main Methods:

• A total of 276 samples (176 abnormal, 100 normal) were analyzed.
• WBC differentials, RBC classification, and PLT estimation were performed using DI-60 and compared with Sysmex XN and/or manual counts.
• RBC morphology and manual counts followed ICSH and CLSI guidelines, respectively.

Main Results:

• Overall concordance for WBCs between DI-60 and manual count was 86.0%.
• Excellent agreement (weighted κ=0.963) was observed for WBC five-part differentials after verification.
• Strong correlations were found for neutrophils (r=0.955), lymphocytes (r=0.871), immature granulocytes (r=0.820), and blasts (r=0.879).
• Platelet counts by DI-60 highly correlated with XN (r=0.945), though it underestimated counts in marked thrombocytosis.
• Notable differences were observed in RBC grading between DI-60 and manual counting based on ICSH criteria.

Conclusions:

• The Sysmex DI-60 demonstrates acceptable performance for WBC differential, RBC classification, and platelet estimation, particularly after verification.
• The system has the potential to optimize hematology laboratory workflows by reducing manual workload.