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学科主题: 临床检验诊断学
题名:
7种半胱氨酸蛋白酶抑制剂C检测系统的分析性能评价
其他题名: Performance evaluation of seven cystatin C analysis systems
作者: 安崇文; 李海霞
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 ; Cystatin C ; Particle-enhanced turbidimetric immunoassay system ; Particle-enhanced nephelometric immunoassay system ; Sol particle immunoassay system
刊名: 检验医学
发表日期: 2013
DOI: 10.3969/j.issn.1673-8640.2013.12.011
期: 12, 页:1106-1111
收录类别: 中国科技核心期刊
文章类型: Journal Article
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(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 BNⅡ system (BNⅡ system),precision,accuracy,limit of blank (LoB)and anti-interference ability were evaluated.Results For 6 systems (A-F)and BNⅡsystem,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 BNⅡ 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 BNⅡ 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 BNⅡ systems, respectively.When Hb≤13 g/L and TG ≤28 mmol/L,A,B and BNⅡ 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-DA47 1 and CAP external quality assessment materials. In a part of analysis systems, analysis performance is not good.
语种: 中文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/43549
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作者单位: 北京大学第一医院检验科,北京,100034

Recommended Citation:
安崇文,李海霞. 7种半胱氨酸蛋白酶抑制剂C检测系统的分析性能评价[J]. 检验医学,2013(12):1106-1111.
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