Axceed 260测定人血清中糖类抗原50性能验证

Performance of verification of Axceed 260(MCLIA) in detecting Carbohydrate antigen 50 in human serum

目的验证Axceed 260磁微粒全自动化学发光免疫分析系统(MCLIA)检测人血清中糖类抗原50(CA50)的分析性能。方法依照美国临床实验室标准化协会(CLSI)公布的EP15-A2、EP28-A3c、EP6-A、EP7-A2标准指南文件,对Axceed260检测CA50项目的精密度、正确度、参考区间、线性范围、分析干扰进行验证。结果 Axceed 260检测CA50项目的批内精密度、实验室内精密度变异系数分别为3.45~4.95%和3.35~4.64%;定值参考物测值在验证区间内;测定线性范围与厂商提供的范围一致;参考区间适用于本地区人群;与CA199,CA125无交叉反应;常规干扰物(胆红素(0.2mg/ml)、血红蛋白(5mg/ml)、甘油三酯(10mg/ml))对试剂盒无影响。结论 Axceed 260磁微粒全自动化学发光免疫分析仪检测糖类抗原CA50的主要分析性能与厂家声明一致,适用于临床检测需求。

Objective To verfiy the analytical performance of the full-automatic magnetic particles chemiluminescence immunoassay（MCLIA） system in the Axceed 260 analyzer for detecting Carbohydrate antigen 50（CA50）. Methods The precision,accuracy,linear range,reference intervals and interference of MCLIA system in the detection of CA50 were evaluated according to the Clinical and Laboratory Standards Institute（CLSI） evaluation protocols including EP15-A2,EP28-A3 c,EP6-A and EP7-A2 documents. Results The within-run precision and between-run precision experiment CV of CA50 were both less than 5%. The linear range was consistent with manufacturer＇s claim. Verification interval including the assigned value of reference materials and reference intervals were suitable for the local crowd. There was no cross reactivity with a high concentration of Cancer Antigen15-3（CA15-3） and Cancer Antigen 125（CA125）. No interferences were detected from bilirubin（0.2mg/ml）,hemoglobin（5mg/ml） and triglycerides（10mg/ml）. Conclusion The main analytical performance of the Axceed 260 analyzer in the detection of CA50 is consistent with manufacturer＇s claim,which could be used for clinical laboratory routine testing.