Bio-Rad D10 Automatic Analyzer for Hemoglobin A1c Detection:Preliminary Evaluation

Objective To evaluate the utilization of Bio-Rad D10 automatic analyzer for hemoglobin A1c detection.Methods In accordance with the NCCLS Document EP10-A,a preliminary evaluation of the D10 HbA1c analyzer was made on calibrators at high,middle and low concentrations for a period of 5 days,and the deviation of HbA1c,total imprecision,the slope,carrying pollution,nonlinearity and drift were calculated,and T test was conducted at the same time.Results The high value,medium value and low value deviations were-0.01%,-0.09% and-0.11%,respectively within the permissive ranges.The total imprecision was 1.148%,0.886% and 0.727%,respectively,and they were all less than the permissive 5% ranges of ADA.There were significant differences in the slopes and no significant difference in their intercepts,nonlinearities,carrying pollutions and drifts.Conclusion The precision and accuracy of Bio-Rad D10 automatic analyzer for hemoglobin A1c detection are very good,and its performance indicators consistent with clinical application requirements.