两种酶法试剂盒检测糖化白蛋白的方法学比对分析

目的： Lucica-L和MAKER试剂盒检测糖化白蛋白的一致性分析。方法采用巢式抽样法抽取广州地区18~60周岁城乡居民共3004例。同时使用Lucica GA-L试剂盒和MAKER GA试剂盒检测入选志愿者的血清白蛋白（ALB）和糖化白蛋白（GA）浓度,采用配对t检验统计分析试验结果。结果白蛋白和糖化白蛋白浓度值在两种厂家试剂间的检测结果均有显著性差异(P<0.05)。两种试剂GA报告值相关性较好(r2=0.962),但差异亦有统计学意义(P<0.05)。偏倚为2.6%。结论用于白蛋白和糖化白蛋白检测的MAKER试剂盒GA结果高于Lucica-L试剂盒,但差异临床可接受。

Methodology comparison of two enzymic method kits in assaying glycated albumin

Objective To evaluate the consistence between the Lucica-L and MAKER assay kits in analyzing glycated albumin. Methods 18~60 years old residents with the amount of 3004 was collected using the Nested sampling method in Guangzhou. The ALB and GA of the volunteers were assayed using Lucica-L kits and MAKER GA kits at the same time. The results were applied comparati ve t-test to perform statistical analysis. Results The difference of the concentrations of ALB and GA were Significant between the two analyzing kits(P<0.05). The final results of the two kits showed excellent correlation(r2=0.962), but the difference was still statistical significance(P<0.05). The bias was 2.6%. Conclusion The GA results assaying by MAKER kit were higher than Lucica-L assay kit. But the bias has clinical acceptability.