Bio-Rad D10全自动糖化血红蛋白仪初步评价

目的初步评价Bio-Rad D10全自动糖化血红蛋白仪测定糖化血红蛋白(HbA1c)的临床应用性能。方法根据美国临床实验室标准化委员会颁布的《定量临床检验方法的初步评价:批准指南(EP10-A)》提供的方法,按照特定顺序连续5d测定低、中、高浓度标准品中的HbA1c,计算偏差、总不精密度,及其截距、斜率、非线性、携带污染和漂移,并进行t检验。结果偏差:低值-0.01%、中值-0.09%、高值-0.11%,均在允许偏差的范围内。总不精密度(用CV表示):低值1.148%、中值0.886%、高值0.727%,均小于美国糖尿病协会(ADA)允许误差5%的范围。截距、漂移、非线性和携带污染均无显著性差异(P0.01),斜率有显著性差异(P0.01)。结论 Bio-RadD10全自动糖化血红蛋白仪测定HbA1c的准确度和精密度良好,性能指标符合临床应用要求。

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

Objective To evaluate the utilization of Bio-Rad D10 automatic analyzer for hemoglobin Alc 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 HbAlc, 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 Alc detection are very good ,and its performance indicators consistent with clinical application requirements.