五种可溯源胱抑素C检测系统结果的一致性评价

摘要

目的：比较4种颗粒增强免疫透射比浊法（ PETIA）与1种颗粒增强免疫散射比浊法（PENIA）胱抑素C（Cys C）检测系统结果的一致性。方法实验性能验证。选择2013年3月北京协和医院内科门诊患者的检测后剩余血清标本共40例用于方法学比对实验。参考CLSI EP15-A2及EP9-A2方案进行比对结果分析。在OlympusAU5400自动生化分析仪上分别应用上海景源、北京利德曼、北京九强和四川迈克生产的PETIA法Cys C试剂（标为A、B、C、D）和西门子BNⅡ上的PENIA法Cys C检测系统（标为E）测定40份比对血清，将4种PETIA法Cys C检测系统A、B、C、D与PETIA法均值以及与PENIA法系统E结果进行相关分析，比较与PETIA法均值以及与PENIA法系统E的偏差和百分偏差。以1、2、3、4 mg/L为医学决定水平，比较各检测系统在医学决定水平处的预期偏差。采用5种检测系统分别测定参考物质ERM-DA471/IFCC，计算各系统的偏倚和百分偏倚。结果系统A、B、C、D、E测定40份比对血清结果分别为1.29（0.89～2.43）、1.30（0.96～2.59）、1.22（0.90～2.44）、1.27（0.96～2.47）、1.14（0.82～2.05）mg/L。偏差图显示在Cys C小于4 mg/L时不同系统的差异较小。 PETIA法A、B、C、D与其均值相关良好，与均值的平均偏差（百分偏差）在-0.017～0.031 mg/L（-3.1％～2.1％）之间，均小于来源于生物学变异的允许偏倚（3.4％）。 A、B、C、D与其均值在医学决定水平处的偏差在-0.176～0.178 mg/L之间。系统A、B、C、D与PENIA法系统E测定结果相关良好，平均偏差（百分偏差）在0.278～0.326 mg/L（12.6％～18.5％）之间，在医学决定水平处的偏差（百分偏差）在0.055～1.079 mg/L （5.51％～26.98％）之间。 PETIA法A、B、C、D Cys C测定ERM-DA471/IFCC的偏倚在0.22～0.39 mg/L（3.9％～7.0％）之间，超出参考物质靶值允许范围，且均大于来源于生物学变异的 Cys C 允许偏倚（3.4％）。 PENIA 法检测系统 E 偏倚为-0.1 mg/L （-1.7％），在ERM-DA471/IFCC靶值允许范围内。结论所评估的4种PETIA法Cys C检测系统的一致性较理想，较未溯源前明显改善，但PETIA法测定结果高于PENIA法。在Cys C低浓度区（4 mg/L以下）时不同系统的差异较小，高浓度区时的差异较大。%Objective To assess the consistency of four standardized cystatin C particle-enhanced turbidimetric assay (PETIA) and one particle-enhanced nephelometric immunoassay (PENIA) measurement systems Methods Performance verification test was conducted according to CLSI EP 15-A2 and EP9-A2. Fourty serum samples in comparative test were obtained from the remaining serum samples of outpatients in Peking Union Medical College Hospital in March 2013.Fourty serum samples were tested on Olympus AU5400 automatic biochemical analyzer ( four PETIA Cys C reagents:Shanghai Jingyuan Co ., Ltd, Beijing Leadman Biochemistry Co ., Ltd, Beijing Strong Biotechnologies , Maker Biotechnology in Sichuan , and labelled as A, B, C, D respectively) and PENIA N Latex Cys C measurement system on Siemens BNⅡ(labelled as E).Correlation analysis were performed among four PETIA methods one PENIA method Differences of each detection system were compared in the medical decision level 1,2,3,4 mg/L.The reference material ERM-DA471/IFCC was measured by five systems and bias ( percentage bias ) was calculate for each system.Results Results of systems A, B, C, D, E were 1.29(0.89-2.43), 1.30 (0.96-2.59), 1.22(0.90-2.44), 1.27(0.96-2.47), 1.14(0.82-2.05)mg/L.Chart shows bias among these five systems was small when Cys C concentration was less than 4mg/L.PETIA method A, B, C, D correlated with their mean value well , with the average deviation from their mean value ( percent deviation) at -0.017 -0.031 mg/L ( -3.1%-2.1%), and all were less than allowed bias from the biological variation (3.4%).The deviation of PETIA method A, B, C, D with their mean value in medical decision level at -0.176 -0.178 mg/L.Systems A, B, C, D correlated well with the result of PENIA method system E , and the mean deviation ( percent deviation ) was at 0.278 -0.326 mg/L ( 12.6%-18.5%) , and the deviation ( percent deviation ) in the medical decision level 0.055 -1.079 mg/L (5.51%-26.98%).Bias of PETIA method A, B, C, D Cys C system measuringERM -DA471/IFCC ranged from 0.22 to 0.39 mg/L ( 3.9%-7.0%) , which exceeded the allowable range of the reference material target value, and were larger than the allowable bias from biological variation (3.4%).Bias ( percent ) of PENIA method system E was -0.1 mg/L ( -1.7%) , within the allowable range of ERM-DA471/IFCC target value .Conclusions The consistency of four assesed PETIA Cys C reagents was relatively ideal, and improved markably after being traced to ERM-DA471/IFCC.Besides, the results of PETIA were higher than those of PENIA .Bias among these five systems was small when Cys C concentration was less than 4 mg/L, and the bias became larger in higher Cys C concentration.