酶法测定糖化白蛋白的分析性能验证与评价  

Analytical performance verification and evaluation of detecting glycated albumin by enzyme method

作　　者：陈远东[1] 杨海[1] 黄小惠[1] 周晓云[1] 邱海山[1] 李康生[2] 

机构地区：[1]广东省惠州市第三人民医院,广东惠州516002 [2]广东省汕头大学医学院微生物学与免疫学教研室,广东汕头515063

出　　处：《医学检验与临床》2016年第7期18-21,29,共5页Medical Laboratory Science and Clinics

摘　　要：目的：参照美国临床和实验室标准化委员会（CLSI）颁布的EP方案对露喜佳GA—L试剂在美国雅培C116200全自动生化分析仪上检测糖化白蛋白进行性能验证与评价，验证其是否符合厂家声明以及是否满足临床需要。方法：参照EP文件分别验证糖化白蛋白检测系统的精密度、正确度、分析测量范围、临床可报告范围、分析灵敏度。结果：液态酶法检测糖化白蛋白批内精密度为0．8％-2％，批总精密度为0．7％-2．6％，低于厂家表明精密度3％；糖化白蛋白（GA）检测低限为0．02g／dl；可报告范围为0．048—115．08g／dl；稀释线性好，在0．0145-2．877g／dl呈线性。结论：露喜佳GA—L试剂在美国雅培C[16200全自动生化分析仪上检测糖化白蛋白分析性能良好，能够准确地定量检测糖化白蛋白，可以更好的反映血糖短期变化情况，能够满足临床需求。Objective： According to the clinical and Laboratory Standards Committee （CLSI） EP regimen, we detected glycated albumin （GA） in CI16200 full automatic biochemical analyzer with GA-L kit, and made the performance validation and evaluation to verify whether it is consistent with the manufacturer＇s statement and whether it meets the clinical needs. Methods： According to the EP scheme, we validated the precision and accuracy of the GA detection system, and analyzed the measurement range, the range of clinical reports, and the sensitivity of the method. Results： The results showed good precision, with in-ran CV is 0.8%-2%, total-run CV was 0.7%-2.6%, less than 3% precision of manufacturer statement. The results also showed high accuracy and high sensitiviW. The minimum limit of quantitation was 0.02g/dl. Clinical reportable range was from 0.048 g/dl to 115.08g/dl. There was good linearity, which was between in 0.0145 and 2.877 g/dl. Conclusion： The enzymatic method used to detect GA had good performances testing on the Abbott laboratories CI16200 automatic biochemical analyzer, which could accurately quantitative detect GA and could better reflect the short-term changes in blood sugar and satisfy the clinical needs.

关 键 词：糖化白蛋白 检测系统 性能评价 

分 类 号：R446.112[医药卫生—诊断学]