摘要
目的对酶化学法测定糖化血红蛋白进行方法学性能的验证。方法参考美国国家临床实验室标准化委员会系列文件和相关文献,结合工作实际对酶化学法测定糖化血红蛋白进行精密度、准确度的分析测量范围和生物参考区间等进行评价,并将实验结果与厂家提供的分析性能或公认的质量指标进行比较。结果批内变异系数（CV）0.87%~1.29%,批间CV1.74%~2.12%;在3.0%~16.0%范围内线性良好Y=1.010X-0.004,r=0.999 7,平均回收率101.37%;该方法与TOSOH G7离子交换高效液相层析法二组比较差异无统计学意义（Y=0.962 2X＋0.045,r=0.994 0,P〉0.05）;分析测量范围（AMR）验证和生物参考区间验证结果均符合质量要求。结论酶化学法测定糖化血红蛋白主要分析性能符合质量目标要求,适合临床检验科应用。
Objective To verify the analytical performance of haemoglobin A1c（HbA1c） tested by chemico-enzymatic method.Methods Referring to NCCLS evaluation protocols and pertinent literature and based on our practical work,we tested the precision,accuracy,analytical measurements range and biotic interval of HbA1c by chemico-enzymatic method,then compared the result with quality index of the manufacturer or generally accepted.Results The within-run coefficient of variation（CV） was 0.87%-1.29% and between-run CVwas 1.74%-2.12%.The linear correlation coefficient of the method was satisfactory（Y=1.010C-0.004,r=0.999 7） in 3.0%-16.0%,and the average recovery rate was 101.37%.The difference of the coefficient of correlation between enzymatic method and high performance liquid chromatography（HPLC） was significant（Y=0.962 2X＋0.045,r=0.994 0,P0.05）.The results of the verification for analytical measurements range（AMR） and biotic interval were accorded with the request of the quality.Conclusion The HbA1c measurements for enzymatic method is accorded with the request of the quality,which can be applied on automatic diagnose.
出处
《检验医学与临床》
CAS
2011年第12期1450-1451,1454,共3页
Laboratory Medicine and Clinic
关键词
糖化血红蛋白
酶化学法
性能验证
haemoglobin A1c
chemico-enzymatic method
verification
