Performance Evaluation of the ARKRAY ADAMS Bridge System Comprising Glucose GA-1171 and HbA1c HA-8180 Analyzers

ABSTRACT

BACKGROUND: In diabetic patients, both glucose and hemoglobin A1c (HbA1c) concentrations are frequently measured to monitor glycemic control. We examined the analytical performance of the recently developed, automated, ADAMS bridge system (Arkray, Inc., Japan) consisting of the ADAMS glucose GA-1171 and the ADAMS HbA1c HA-8180 analyzers, which allows the consecutive measurement of glucose and HbA1c concentrations. METHODS: We evaluated precision, linearity, carry-over, effects of hematocrit, and turnaround time. Method comparison was conducted between GA-1171 and UniCel DxC 800 (Beckman Coulter, Inc., USA) and Synchron CX3 Delta (Beckman Coulter) for glucose, and between HA-8180 and HLC-723 G8 (Tosoh Bioscience, Inc., Japan) for HbA1c measurements. RESULTS: Total precision (% CV) in measuring high and low level controls was 1.11% and 1.21% for glucose using GA-1171, and 0.86% and 1.3% for HbA1c using HA-8180, respectively. In the linearity test, R2 was 0.9997, 0.9991 and 0.9973 when measuring plasma glucose (58-532 mg/dL), whole blood glucose (74-401 mg/dL), and HbA1c concentrations (4.7-14.7%), respectively. Good correlation was observed between GA-1171 and DxC 800 (r=0.9987), and between HA-8180 and HLC-723 G8 (r=0.9980). Carry-over effect was less than 0.5% for glucose and HbA1c. Turnaround time was reduced from 7 min (CX3 Delta) and 1.43 min (HLC-723 G8) to 2.16 min (GA-1171) and 1.54 min (HA-8180), respectively, when whole blood glucose and HbA1c concentrations were measured consecutively by the ADAMS bridge system. CONCLUSIONS: The ADAMS bridge system had a simple operating procedure and showed an adequate performance and a rapid turnaround time.