两套检测系统糖化血红蛋白检测结果的一致性分析

Consistency Analysis of the Results of Glycosylated Hemoglobin Detection in Two Detection Systems

目的探讨两套检测系统糖化血红蛋白(HbA1c)检测结果的一致性。方法按照EP9-A2文件的要求,以PRIMUS Ultra2 HbA1c分析仪为参比系统,PRIMUS PDQ-Plus HbA1c分析仪为待评系统,使用新鲜抗凝全血对两套检测系统的结果进行比对分析,并评估其在不同医学决定水平(XC)处的相对偏倚(SE%)。结果两套检测系统HbA1c检测结果的回归方程为Y=0.9927X+0.1208,相关系数r^2=0.9944,不同XC处的SE%均小于1/2TEa,能被临床所接受。结论 PRIMUS PDQ-Plus与PRIMUS Ultra2 HbA1c分析仪检测结果具有良好的一致性,可使用相同的参考范围,能满足临床对糖尿病患者的诊断、治疗和监测需求。

Objective To investigate the two detection system of glycosylated hemoglobin(HbA1c)the consistency of test results.Methods According to the requirements of the EP9-A2 documents,the PRIMUS Ultra2 HbA1c analyzer as the reference system,the PRIMUS PDQ-Plus HbA1c analyzer for evaluation system,the use of fresh anticoagulant blood were compared and analyzed the results of two detection system,and evaluate the medical decision level in different relative bias(XC)at(SE%).Results Two the regression equation of HbA1c detection system was Y=0.9927X+0.1208,correlation coefficient 2=0.9944,and SE%at different XC were less than 1/2TEa,which could be accepted by clinical practice.Conclusion The results of PRIMUS PDQ-Plus and PRIMUS Ultra2 HbA1c analyzer have good consistency and can be used in the same reference range.It can meet the needs of clinical diagnosis,treatment and monitoring of diabetic patients.