液态酶法糖化血清白蛋白试剂性能评价

Evaluation of the Liquid Enzymatic Method for the Measurement of Glycated Serum Albumin

目的对液态酶法糖化血清白蛋白(GSA/GA)试剂盒的性能进行评价。方法参考美国临床和实验室标准化协会(CLSI)文件(EP15-A2,EP6-A,EP28-A3C)及相关文献,对液态酶法GA试剂盒的精密度、准确度、回收试验、线性范围、干扰因素和生物参考区间等进行评价,并将实验结果与制造商提供的分析性能或公认的质量指标进行比较。结果 GA低值和高值样本对应的重复性不精密度变异系数(CV)分别为0.89%和1.38%,实验室内不精密度CV分别为1.28%和1.51%;相对偏倚在-0.70%^-1.54%之间,偏差符合率为100%;平均回收率为98.0%;在8.58%~73.94%范围内线性良好;对于游离胆红素、结合胆红素、乳糜、血红蛋白和葡萄糖等共存物质的抗干扰能力均能够达到或超过厂家声明;生物参考区间验证结果在11.0%~17.0%范围内。结论液态酶法糖化血清白蛋白性能良好,可作为一个糖尿病短期控制的有效指标在临床广泛应用。

Objective To evaluate the liquid enzymatic method for the measurement of glycated serum albumin（ GSA/GA） assay kit. Methods According to Clinical and Laboratory Standards Institute（ CLSI） evaluation protocols EP15-A2,EP6-A,EP28-A3 C and pertinent literature,the precision,accuracy,recovery test,linearity,interference and reference interval of GA assay kit were investigated,and then the results were analyzed with manufacturer quality index. Results The repeatability and within-laboratory precision coefficients of variation（ CV） of both low and high levels of GA were 0. 89%,1. 38% and1. 28 %,1. 51%,respectively.The relative bias was between- 0. 70 to- 1. 54%,and the bias coincidence was 100%. The average recovery rate was 98. 0%. The detection results showed a good linearity in a range of 8. 58% to 73. 94%. The antiinterference ability for coexistence material such as free bilirubin,conjugated bilirubin,chyle,hemoglobin and glucose could reach or exceed the manufacturer declaration. The biotic reference intervals were in the range of11. 0% to 17. 0%, provided by pertinent literature. Conclusion The liquid enzymatic method for the measurement of GA assay kit has a good performance,and can be widely used in clinical application as a useful short-term indicator for diabetes control.