前清蛋白定量检测限和功能灵敏度的评价及临床应用

Evaluation of quantitative detection limit and functional sensitivity of prealbumin and their clinical applications analysis

目的对Roche Modular P全自动生化分析仪检测前清蛋白(PA)的空白限(LoB)、检测限(LoD)、定量检测限(LoQ)以及功能灵敏度(FS)进行评价。方法参照美国临床和实验室标准化协会(CLSI)EP-17A文件,将空白样品生理盐水及系列低浓度样品在Roche Modular P全自动生化分析仪上进行检测确定该方法的空白限、检出限和定量检测限。依据国内通用方法确定功能灵敏度。结果 PA的空白限为16.35mg/L,检测限为18.23mg/L,定量检测限暂无法评价,功能灵敏度为25.00mg/L。结合其可报告范围的低值,确定其临床的报告范围及报告方式。结论建立了PA在Roche Modular P全自动生化分析仪上检测的定量检测限,为临床诊断和治疗提供了更有价值的信息,对不同评价的方法进行比较,明确了不同方法实际应用的优点以及局限性。

Objective To evaluate the limit of blank （LoB）,limit of detection （LoD）,limit of quantitation（LoQ）and functional sensitivity （FS）of prealbumin （PA）detected by the Roche Modular P automatic biochemical analyzer.Methods According to the EP17A file of the American Clinical and Laboratory Standards Institute （CLSI）,saline as the blank sample and a series of low con-centration samples were detected by the Roche Modular P automatic biochemical analyzer for determining LoB,LoD and LoQ.And FS was determined based on the domestic universal method .Results LoB of PA was 16.35 mg/L,LoD was 18.23 mg/L,LoQ was temporarily unable to evaluate and FS was 25.00 mg/L.The report scope and the report mode in clinic were affirmed by combi-ning with the low value of the reportable scope.Conclusion LoD of PA detected by the Roche Modular P automatic biochemical an-alyzer is established,which provides more valuable information for clinical diagnosis and treatment.Conducting the comparison of different evaluation methods determines the advantages and limitation of the practical application of different methods.