7种半胱氨酸蛋白酶抑制剂C检测系统的分析性能评价

目的评估7种半胱氨酸蛋白酶抑制剂C（CysC）检测系统的分析性能。方法应用美国临床实验室标准化协会（CLSI）系列文件评估5个颗粒增强免疫透射比浊（PETIA）检测系统和1个均相溶胶颗粒免疫法（SPIA）检测系统的精密度、正确度、空白限（LoB）、抗干扰性以及与SIEMENSBNⅡ颗粒增强免疫散射比浊（PE—NIA）检测系统（简称BNⅡ系统）的相关性和偏差。结果6个检测系统（以A—F表示）和BN1I系统在CysC浓度为0．8～5．0mg／L时的总批内变异系数（CV）均〈3．75％，总批间CV除E系统外均〈5％；正确度验证显示A—E系统和BNⅡ系统测定ERM—DA471的绝对偏倚分别为0．00、0．00、1．01、-0．01、-0．50和-0．35mg／L，相对偏倚分别为0％、0％、18．43％、-0．18％、-9．12％和-6．39％；测定CAP室间质评物显示仅D系统和BN1I系统较为理想。A～F系统及BNⅡ系统的LoB分别为0．00、0．00、0．31、0．01、0．10、0．06和〈0．05mg／L。干扰分析显示Hb≤13g／L、TG≤28mmol／L时，对A、B系统及BNⅡ系统无明显影响（干扰〈±10％），其他系统均有不同程度干扰。相关分析显示A～F系统与BN1I系统相关性较好相关系数（r）均〉0．975，P〈0．01]。偏差分析显示，A～F系统与BNII系统的平均偏差分别为－0．02、－0．10、－0．31、0．05、0．04、0．36mg／L。结论CysC各检测系统测定有证参考物质ERM—DA471的最大偏倚可达到lmg／L，最大相对偏倚为18．43％；其中PENIA在测定ERM—DA471和CAP室间质评物时结果低于PETIA；部分检测系统分析性能存在不足。

Performance evaluation of seven cystatin C analysis systems

Objective To evaluate the analysis performance for 7 cystatin C （ Cys C ） analysis systems. Methods A total of 5 particle-enhanced turbidimetric immunoassay （PETIA） systems and 1 sol particle immunoassay （SPIA） system were evaluated according to the documents of the Clinical and Laboratory Standards Institute （CLSI） , and their correlation with particle-enhanced nephelometric immunoassay （PENIA） system from the SIEMENS BN ]I system （BN 1I system） , precision, accuracy, limit of blank （LoB） and anti-interference ability were evaluated. Results For 6 systems （A-F） and BN 1I system, the total within-run coefficients of variation （CV） were all 〈 3.75% , and except E, the total between-run CV were all 〈 5% , when Cys C concentration was 0.8-5.0 mg/L. For A-E and BN 1I systems, accuracy verification showed that the absolute biases for measuring ERM-DA471 were 0.00,0.00,1.01, - 0.01, - 0.50 and -0.35 mg/L respectively,and the relative biases were 0% ,0% ,18.43%, -0.18%, -9. 12% and -6.39% respectively. The measurement of CAP external quality assessment materials showed that D and BN II systems had desirable results. The LoB were 0. 00,0. 00,0. 31,0. 01,0. 10,0.06 and 〈 0.05 mg/L for A-F and BN It systems, respectively. When Hb ~〈 13 g/L and TG ~〈 28 mmol/L, A, B and BN II systems were not significantly influenced （interference 〈 _＋ 10% ）. Other systems were influenced with different levels. The A-F systems correlated well with BNII system, and the correlation coefficients （r） were all 〉 0. 975 （P 〈 0.01 ）. Compared with BN II system,the average deviations were -0. 02, -0. 10, -0. 31,0. 05,0. 04 and 0. 36 mg/L for A-F systems, respectively. Conclusions The maximum bias can reach 1 mg/L when measuring the reference materials for Cys C analysis systems, and the maximum relative bias is 18.43%. The results of PENIA system are lower than those of PETIA system when measuring ERM-DA471 and CAP external quality assessment materials. In a part of analysis systems, analysis performance is not good.