7种半胱氨酸蛋白酶抑制剂C检测系统的分析性能评价  

Performance evaluation of seven cystatin C analysis systems

作　　者：安崇文[1] 李海霞[1] 

机构地区：[1]北京大学第一医院检验科,北京100034

出　　处：《检验医学》2013年第12期1106-1111,共6页Laboratory Medicine

摘　　要：目的评估7种半胱氨酸蛋白酶抑制剂C(Cys C)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SIEMENS BNⅡ颗粒增强免疫散射比浊(PENIA)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BNⅡ系统在Cys C浓度为0.8~5.0 mg/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-0.35 mg/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BNⅡ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<0.05 mg/L。干扰分析显示Hb≤13 g/L、TG≤28 mmol/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BNⅡ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、0.36 mg/L。结论 Cys C各检测系统测定有证参考物质ERM-DA471的最大偏倚可达到1 mg/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。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

关 键 词：半胱氨酸蛋白酶抑制剂C 颗粒增强免疫透射比浊检测系统 颗粒增强免疫散射比浊检测系统 均 相溶胶颗粒免疫检测系统 

分 类 号：R446.1[医药卫生—诊断学]