2026 Volume 75 Issue 2 Pages 273-279
A fundamental performance evaluation of whole blood measurement was conducted using the “MetaboLead HbA1c” reagent (Canon Medical Diagnostics Corporation), which is based on the enzymatic method as the measurement principle. The parallel precision, intra-laboratory precision, linearity, and influence of modified hemoglobin showed favorable results. Four cases of discrepancy were observed when correlating with the immunoassay method, and verification using washed blood cells suggested the possibility of influence from plasma components. Regarding the impact of coexisting substances, a negative error was observed when conjugated bilirubin and free bilirubin exceeded approximately 20 mg/dL. However, the bilirubin check function of DM-JACK Ex+ (Canon Medical Diagnostics Corporation) enables the identification of bilirubin presence, and by measuring the blood cell layer after centrifugation, the effects of bilirubin can be avoided. The basic performance of this reagent in whole blood samples was favorable, and as whole blood samples became measurable, the impact of hemolysis, centrifugation, and sampling position on measurement was avoided, leading to stable results with minimal measurement error, which is expected to contribute to routine testing and diabetes care.
