HLC-723G8分析仪的糖化血红蛋白质控品的研制与应用
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摘要
目的用溶血法研制适合HLC-723G8分析仪的糖化血红蛋白(HbA1c)质控品,并评价其应用效果。方法选择临床标本2份,研制溶血比例,按照制备程序,保存于3种温度,评价自制质控品的稳定性及不同温度下的变化特点。结果自制质控品的溶血比例在80∶1～500∶1,中、高值累积10个月的不精密度分别为1.21%、0.83%,室温颜色变化最快,-20℃保存稳定性>300d。结论自制HbA1c质控品按照溶血比例,可使HbA1c水平在HLC-723G8分析仪上顺利被检测到,质控品的稳定性符合国际对HbA1c室内不精密度<2%的性能要求,值得临床参考使用。
Objective To develop aquality control product of glycosylated hemoglobin(HbA1 c)suitable for HLC-723 G8 analyzer by hemolysis method and evaluate its application effect.Methods Two clinical specimens were selected and stored at three kinds of temperatures according to the preparation procedure.The hemolysis ratio was developed and the stability of the self-made quality control product was evaluated.Results The hemolysis ratio of self-made quality control products was between 80∶1 and 500∶1.The coefficient of variation of the middle and high value accumulated for 10 months were 1.21% and 0.83%respectively.The color change at room temperature was the fastest,and the storage stability at-20℃ was more than 300 days.Conclusion The self-made quality control substance of HbA1 ccan detect the concentration of HbA1 c smoothly on the HLC-723 G8 analyzer according to the hemolysis ratio.The stability of quality control product meets the international performance requirements of indoor imprecision of HbA1 c(less than 2%),which is worthy of clinical reference.
Objective To develop aquality control product of glycosylated hemoglobin(HbA1 c)suitable for HLC-723 G8 analyzer by hemolysis method and evaluate its application effect.Methods Two clinical specimens were selected and stored at three kinds of temperatures according to the preparation procedure.The hemolysis ratio was developed and the stability of the self-made quality control product was evaluated.Results The hemolysis ratio of self-made quality control products was between 80∶1 and 500∶1.The coefficient of variation of the middle and high value accumulated for 10 months were 1.21% and 0.83%respectively.The color change at room temperature was the fastest,and the storage stability at-20℃ was more than 300 days.Conclusion The self-made quality control substance of HbA1 ccan detect the concentration of HbA1 c smoothly on the HLC-723 G8 analyzer according to the hemolysis ratio.The stability of quality control product meets the international performance requirements of indoor imprecision of HbA1 c(less than 2%),which is worthy of clinical reference.
引文
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[13]薛一峰,黄建荣.自制电化学发光检测N末端B型利钠肽室内质控物及应用评价[J].国际检验医学杂志,2016,37(19):2718-2722.
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[16]石晓东,路秀玲,郑春阳,等.血红蛋白在膜分离过程中的氧化规律和抗氧化探索[J].过程工程学报,2005,5(6):659-663.
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[18]朱永宁.关于血红蛋白(Hb)低温稳定性的研究[J].大连大学学报,2001,22(6):42-46.
[2]居漪.再谈糖化血红蛋白[J].检验医学,2015,30(6):547-553.
[3]许华斌,李媛媛.血细胞质控物开封后的稳定性研究[J].国际检验医学杂志,2009,31(5):456-458.
[4]International Organization for Standardization.Reference material general and statigtical principles for certifications:ISO Guide 35[S].Geneva:ISO,2006.
[5]崔婷,马建锋.以患者新鲜血清标本制备室内控品的应用研究[J].检验医学与临床,2014,11(6):737-738.
[6]JAMTSHO R X.Stability of lyophilized human serum for use as quality control material in Bhutan[J].Indian J Clin Biochem,2013,28(4):418-421.
[7]袁学进,李全双,邓演超.自制糖化血红蛋白质控物及其性能评价[J].检验医学与临床,2012,9(18):2310-2311.
[8]刁奇志,黄利君,莫展,等.离子交换层析法离子交换层析法测量糖化血红蛋白的不确定度评定及应用[J].中国医药导报2018,15(10):131-134.
[9]林振忠,陈雅斌,蒋建家,等.泉州健康成人糖化血红蛋白A1c水平及参考区间的研究[J].中国循证医学杂志,2016,8(10):1121-1126.
[10]唐立萍,欧元祝,刘文彬,等.运用上海地区室间质评结果评价2种糖化血红蛋白POCT分析仪[J].检验医学,2018,6(4):184.
[11]李金明,申子瑜.正确认识临床实验室认可与提高检验质量之间的关系[J].中华检验医学杂志,2007,30(2):136-139.
[12]张秀明,庄俊华,郑松柏,等.临床化学发光免疫法检测AFP的分析性能验证与实验方法[J].中华检验医学杂志,2007,30(11):1293-1297.
[13]薛一峰,黄建荣.自制电化学发光检测N末端B型利钠肽室内质控物及应用评价[J].国际检验医学杂志,2016,37(19):2718-2722.
[14]SACKS D B,ARNOLD M,BAKRIS G L,et al.Position statement executive summary:guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus[J].Diabetes Care,2011,34(6):1419-1423.
[15]NORDIN G,DYBKAER R.Recommendation for term and measurement unit for"HbA1C"[J].Clin Chen Lab Med,2007,45(8):1081-1082.
[16]石晓东,路秀玲,郑春阳,等.血红蛋白在膜分离过程中的氧化规律和抗氧化探索[J].过程工程学报,2005,5(6):659-663.
[17]沈同,王镜岩,赵邦悌,等.生物化学(上)[M].北京:高等教育出版社,1990:141-143.
[18]朱永宁.关于血红蛋白(Hb)低温稳定性的研究[J].大连大学学报,2001,22(6):42-46.