应用CLSI EP10-A2指南评价国产α1-酸性糖蛋白试剂  

Evaluation by CLSI EP10-A2 Document on α1-Acid Glycoprotein Reagent

作　　者：孙艳虹[1] 高玲[1] 曾智杰[1] 姚真荣[1] 龙伟清[1] 姜傥[1] 

机构地区：[1]中山大学附属第一医院检验医学部,广州510080

出　　处：《现代检验医学杂志》2013年第1期38-41,44,共5页Journal of Modern Laboratory Medicine

摘　　要：目的 利用CLSI EP10-A2指南初步评价上海景源医疗器械有限公司生产的α1-酸性糖蛋白（AGP）试剂盒的临床应用性能.方法 厂家提供高、低值质控品,自配中值质控品,使用日立7180A全自动生化分析仪,连续5天,每天按中、高、低、中、中、低、低、高、高、中的顺序连续测定各浓度样本一批.第一个中值仅作为测定起始用,不纳入统计.后面9个数据中的任何一个不及格,则全部数据都必须弃掉,重新测定.得到所有数据后通过统计软件计算出偏差、不精密度等统计参数.结果 低、中、高三种浓度的AGP质控检测偏差分别为0.093,0.061和0.269 mg/L,均低于标定偏差.三个浓度总不精密度分别为3.87%,1.27%和3.19%,均低于最大允许总不精密度.线性回归方程为Y＝0.071 6X2＋0.563 7X＋0.586 7,相关系数R2＝0.992 7,P＜0.95,说明评价的线性范围符合要求.斜率：1.958（P＞0.01）,携带污染：0.007（P＞0.01）,线性：-0.131（P＞0.01）,漂移：0.002（P＜0.01）.结论 上海景源医疗器械有限公司生产的α1-酸性糖蛋白（AGP）试剂盒及其配套质控品和定标物经用CLSI EP10-A2文件所提供的方法评价,其线性、偏差、总不精密度及抗交叉污染能力均达到标准,在一定范围内有良好的线性关系,携带污染率较低,稳定性较好,能满足临床常规检测和科研需求.Objective Preliminary evaluation of alphal acid glycoprotcin （ACP）kit of Shanghai Jingyuan medical devices Co.Ltd. for clinical application performance using Clinical and Laboratory Standards Institute （CLSI） EP10-A2. Methods High and low quality control materials were provided by the manufacturer of reagent and middle quality control material was made by laboratory. The control materials were measured continuously at the order of medium, high, low, medium, medium, low, low, high,high,medium every day for 5 days. The first measurment only was as the starting value, and was not included in statistics. Any of the 9 behind data failed, then all data should be discarded and redetermined. All data were calculated by statistical software to get the bias,imprecision and other statistical parameters. Results The deviations of the low,medium and high quality control of AGP were 0. 093,0. 061 and 0. 269 mg/L seperately,and all of them were lower than the calibration error. The total imprecision of the three concentrations were 3.87 %, 1.27 % and 3.19 % seperately,lower than the maximum allowable total imprecision. Linear regression equation Y= 0. 071 6χ^2 ＋0. 563 7X ＋ 0. 586 7, correlation coefficient R^2 = 0. 992 7, greater than 0.95, indicating that the linear range of evaluation meets the requirements. Slope： 1.958 （P〉 0.01） ; carryover：0. 007 （P〉0. 01） ;linear：-0. 131 （P〉0. 01） ;Drift..0. 002（P〈0. 01）. Conclusion Evaluated by CLSI EP10-A2 document on Medical Devices Co. Ltd. Shanghai Jingyuan production of α1-acid glycoprotein （AGP）, the linear, bias, imprecision and the capacity of anti-total cross-contamination were up to standard. The reagent had a good linear relationship within a certain range,low carryover and stable can meet routine clinical testing and research needs.

关 键 词：Α1-酸性糖蛋白 质量控制 性能评价 

分 类 号：R446[医药卫生—诊断学]