四种国产化学发光免疫分析系统检测C-肽和胰岛素的性能验证
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摘要
目的对四种国产化学发光免疫分析设备(新产业、迈瑞、安图、长光华医,随意标定为A、B、C、D)的配套定量检测试剂盒中C-肽和胰岛素进行性能验证,评价其是否满足本实验室的质量管理要求,同时给其他相关实验室在国产设备使用方面一个参考。方法方法学性能验证。参考美国临床和实验室标准协会(Clinical and Laboratory Standards Institute,CLSI)文件要求和相关文献,对四种国产设备配套的C-肽和胰岛素进行精密度验证、方法学比对、分析测量范围验证、生物参考范围和携带污染进行验证。结果四种国产化学发光检测系统的C-肽和胰岛素项目的精密度验证结果均符合本实验室质量要求;四种国产检测系统与进口设备测定结果之间的相关性显著(均P <0. 05),相关系数在0. 61～1.0之间;分析测量范围、生物参考区间和携带污染验证结果均符合要求。结论四种国产化学发光设备的C-肽和胰岛素项目的精密度、分析测量范围、生物参考区间和携带污染等基本能满足临床需要,与进口设备检测结果相比较其相关性尚可,但医学决定水平处偏倚可接受性差。
Objective To validate the performance on four domestic chemiluminescence systems(Shenzhen New Industry, SNIBE, Mindray, Antobio, HYBIOME randomized to A, B, C, D), for C-PEPTIDE(C-P) and INSULIN(INS) quantitative assay kits, and to evaluate whether the results can meet the quality requirements of our laboratory and so to provide a reference to medical laboratories. Methods Performance verification tests were conducted. According to the standard of CLSI and combining with published work, we validated the precision, methodological comparison, analytical measure range, reference interval and carry pollution rate in four systems. Results The main performance of four detection systems could meet our quality control requirements. The correlations of the test results between A-D detection systems and the imported equipment were significant(all P < 0. 05),and the correlation coefficients were between 0. 61-1. 00. The results of analytical measure range, reference interval and carry pollution rate were certified to meet the quality control requirements. Conclusion The precision, linear range of C-PEPTIDE and INSULIN of four domestic chemiluminescent devices basically meet the clinical needs, and the correlation is acceptable, but the medical decision level is poorly acceptable.
Objective To validate the performance on four domestic chemiluminescence systems(Shenzhen New Industry, SNIBE, Mindray, Antobio, HYBIOME randomized to A, B, C, D), for C-PEPTIDE(C-P) and INSULIN(INS) quantitative assay kits, and to evaluate whether the results can meet the quality requirements of our laboratory and so to provide a reference to medical laboratories. Methods Performance verification tests were conducted. According to the standard of CLSI and combining with published work, we validated the precision, methodological comparison, analytical measure range, reference interval and carry pollution rate in four systems. Results The main performance of four detection systems could meet our quality control requirements. The correlations of the test results between A-D detection systems and the imported equipment were significant(all P < 0. 05),and the correlation coefficients were between 0. 61-1. 00. The results of analytical measure range, reference interval and carry pollution rate were certified to meet the quality control requirements. Conclusion The precision, linear range of C-PEPTIDE and INSULIN of four domestic chemiluminescent devices basically meet the clinical needs, and the correlation is acceptable, but the medical decision level is poorly acceptable.
引文
[1] Clinical and Laboratory Standards Institute. User Verification of Performance for Precision and Trueness; Approved Guideline——Second Edition[S]. Wayne, PA:CLSI. 2005.
[2] Clinical and Laboratory Standards Institute. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition[S]. Wayne,PA:CLSI,2013.
[3] Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures:a statistical approved guideline[S]. Wayne,PA:CLSI,2003.
[4] Clinical and Laboratory Standards Institute. Defining, Establishing,and Verifying Reference Intervals in the Clinical laboratory[S].Wayne,PA:CLSI,2008
[5]中国合格评定委员会.CANS-CL38医学实验室质量和能力认可准则在临床化学检验领域的应用说明(ISO15189:2012)[EBOL].(2015-09-13)
[6]王婷婷,单凤玲,陆汉魁.不同化学发光免疫分析系统检测亚临床甲状腺功能减退症血清促甲状腺激素的结果对比[J].中华核医学与分子影像杂志,2017,37(6):342-345.
[7]宋超,张曙云,周俊,等.CA19-9测定在4个免疫检测系统的差异及互认能力的评估[J].中华检验医学杂志,2013,36(9):812-817.
[8]张琪,程歆琦,邓成艳,等.三种化学发光免疫方法检测性激素项目的可比性研究[J].中华检验医学杂志,2016,39(12):964-966.
[2] Clinical and Laboratory Standards Institute. Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition[S]. Wayne,PA:CLSI,2013.
[3] Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures:a statistical approved guideline[S]. Wayne,PA:CLSI,2003.
[4] Clinical and Laboratory Standards Institute. Defining, Establishing,and Verifying Reference Intervals in the Clinical laboratory[S].Wayne,PA:CLSI,2008
[5]中国合格评定委员会.CANS-CL38医学实验室质量和能力认可准则在临床化学检验领域的应用说明(ISO15189:2012)[EBOL].(2015-09-13)
[6]王婷婷,单凤玲,陆汉魁.不同化学发光免疫分析系统检测亚临床甲状腺功能减退症血清促甲状腺激素的结果对比[J].中华核医学与分子影像杂志,2017,37(6):342-345.
[7]宋超,张曙云,周俊,等.CA19-9测定在4个免疫检测系统的差异及互认能力的评估[J].中华检验医学杂志,2013,36(9):812-817.
[8]张琪,程歆琦,邓成艳,等.三种化学发光免疫方法检测性激素项目的可比性研究[J].中华检验医学杂志,2016,39(12):964-966.