两套检测系统糖化血红蛋白检测结果的一致性分析.docVIP

两套检测系统糖化血红蛋白检测结果的一致性分析 　　摘 要：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r2=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。 　　关键词：糖化血红蛋白分析仪；比对分析；偏倚评估；一致性 　　中图分类号：R446.1 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.01.026 　　文章编号：1006-1959（2018）01-0074-03 　　Consistency Analysis of the Results of Glycosylated Hemoglobin Detection in Two Detection Systems 　　LUO Ying-jie1，LIN Feng2，LIU Yan-ting1，XIAO Guang-jun1 　　（1.Department of Laboratory，Suining Central Hospital，Suining 629000，Sichuan，China； 　　2.Major in Medical Laboratory Technology，Yaan Vocational and Technical College，Yaan 625000，Sichuan，China） 　　Abstract：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 r2=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. 　　Key words：Glycosylated hemoglobin analyzer；Comparison analysis；Bias assessment；Consistency 　　糖化血?t蛋白（HbA1c）是红细胞内的血红蛋白（Hb）与糖类（主要是葡萄糖）经非酶促反应结合而形成的化合物，可以反映患者测定前120 d的平均血糖水平，与血糖等传统的糖尿病诊断指标比较，其具有个体内生物学变异小（ 　　1材料与方法 　　1.1仪器与试剂 PRI