[1]罗映杰,林凤,刘艳婷,等.两套检测系统糖化血红蛋白检测结果的一致性分析[J].医学信息,2018,31(01):74-76.[doi:10.3969/j.issn.1006-1959.2018.01.026]
　LUO Ying-jie,LIN Feng,LIU Yan-ting,et al.Consistency Analysis of the Results of Glycosylated Hemoglobin Detection in Two Detection Systems[J].Journal of Medical Information,2018,31(01):74-76.[doi:10.3969/j.issn.1006-1959.2018.01.026]
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两套检测系统糖化血红蛋白检测结果的一致性分析()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
31卷
期数:
2018年01期
页码:
74-76
栏目:
论著
出版日期:
2018-01-01

文章信息/Info

Title:
Consistency Analysis of the Results of Glycosylated Hemoglobin Detection in Two Detection Systems
文章编号:
1006-1959（2018）01-0074-03
作者:
罗映杰1; 林凤2; 刘艳婷1; 肖光军1
1.遂宁市中心医院检验科，四川遂宁629000曰 2.雅安职业技术学院医学检验技术专业，四川雅安625000
Author(s):
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,Ya'an Vocational and Technical College,Ya'an 625000,Sichuan,China
关键词:
糖化血红蛋白分析仪; 比对分析; 偏倚评估; 一致性
Keywords:
Key words：Glycosylated hemoglobin analyzer; Comparison analysis; Bias assessment; Consistency
分类号:
R446.1
DOI:
10.3969/j.issn.1006-1959.2018.01.026
文献标志码:
A
摘要:
目的探讨两套检测系统糖化血红蛋白（HbA1c）检测结果的一致性遥方法按照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%）遥结果两套检测系统HbA1c 检测结果的 回归方程为Y=0.9927X+0.1208，相关系数2=0.9944，不同XC 处的SE%均小于1/2TEa，能被临床所接受遥结论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 的诊断尧治疗和监测需求遥
Abstract:
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 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

参考文献/References:

[1]卫生部临床检验中心,北京市医疗器械研究所,北京大学人 民医院.糖化血红蛋白实验室检测指南[J].中国糖尿病杂志, 2013,21(8):673-678.
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更新日期/Last Update: 2018-01-22