免疫比浊法脂蛋白(a)测定试剂盒性能验证  

Performance Verification of Lipoprotein(a)Assay Kit

作　　者：李学会[1] 丁元廷[1] 赵璇璇 张望明[1] LI Xuehui;DING Yuanting;ZHAO Xuanxuan;ZHANG Wangming(Department of Clinical Laboratory,Guizhou Province Hospital of Traditional Chinese Medicine,Guiyang,Guizhou 520100,China;Guizhou Medcial University,Guiyang,Guizhou 550025,China)

机构地区：[1]贵阳中医学院第一附属医院检验科,520100 [2]贵州医科大学,贵阳550025

出　　处：《国际检验医学杂志》2017年第A02期93-95,共3页International Journal of Laboratory Medicine

摘　　要：目的主要验证贵州某生物工程有限公司生产的脂蛋白(a)测定试剂盒(免疫比浊法)在西门子ADVIA1800全自动生化分析仪上的性能指标是否满足相关法规和试剂说明书要求并通过与西门子原装配套试剂进行比对试验观察两者相关性。方法此次实验参考WS/T420-2013临床实验室对商品定量试剂盒分析性能的验证、CLSIEP文件制定性能验证方案,依次对最低检测限、精密度、线性范围、正确度、参考区间进行验证。结果最低检测限为1.509,批内精密度为0.41%、0.33%,批间精密度为0.57%、0.32%,线性范围为0~1200mg/L(R=0.9976),正确度相对偏差为0.26%、6.48%、-1.20%,与西门子原装配套试剂进行比对试验得到回归方程为:Y=0.9949X+2.3435(R=0.9947),参考区间验证只有1例超出参考值范围。结论验证结果均满足相关法规和试剂说明书要求,验证结论为合格。与西门子原装配套试剂进行比对试验发现两者具有较高的相关性。Objective This study is mainly to verify the Production of lipoprotein(a)assay kit,that is pruducted by a biological engineering co of guizhou,performance index on Siemens ADVIA1800automatic biochemical analyzer.And find the result whether meet the requirements of relevant laws and regulations and the reagent instruction.through Sample than with Siemens original reagent test to observe both correlation.Methods The test plan reference WS/T420-2013and CLSI EP file.This experiment mainly verifies the minimum detection limit,precision,linear range,accuracy and reference range.Results The minimum detection limit of1.509,within-run precision are0.41%and0.33%.between-run precision are0.57%and0.32%.linear range is0-1200mg/L(R=0.9976),the right degree of relative deviation are0.26%,6.48%,1.20%,Regression equation is Y=0.9949+2.3435X(R=0.9947)that comparison with Siemens original auxiliary reagents,reference range is only1case exceeds reference range.Conclusion All of validation results meet the requirement of related laws and regulations and the reagent instruction.The test conclusion of qualified.Compare with Siemens original reagent found that both have high correlation.

关 键 词：脂蛋白(a)试剂 免疫比浊法 性能验证 

分 类 号：R446.112[医药卫生—诊断学]