CLSI EP7-A2文件在临床化学分析干扰试验中的应用评价

目的探讨美国临床实验室标准化协会（CLSI）EP7-A2文件在临床化学分析干扰评价试验中的应用价值。方法根据CLSI EP7-A2文件,利用已开发上市的干扰试剂盒对前白蛋白（PA）进行干扰评价试验。结果配对差异实验结果显示0.2 g/L游离胆红素（FBil）、0.4 g/L结合胆红素（CBil）和2.41 g/L血红蛋白（Hb）对PA测定无干扰,835浊度的乳糜对PA测定有负干扰。5个浓度系列的剂量效应实验结果显示乳糜浊度对PA测定可产生线性负干扰。结论依据EP7-A2文件,利用已开发上市的干扰试剂盒,应用医学统计软件统计分析,是一个具有一定应用价值的分析干扰评价方法。

Application evaluation of CLSI EP7-A2 for the interference test in clinical chemistry

Objective To explore the application value of Clinical and Laboratory Standards Institute（CLSI） EP7-A2 for the interference test in clinical chemistry.Methods Prealbumin（PA） was tested according to CLSI EP7-A2 experimental procedures by means of interference reagent kits on market.Results The paired-difference test results showed that 0.2 g/L free bilirubin（FBil）,0.4 g/L conjugated bilirubin（CBil）and 2.41 g/L haematoglobin（Hb） had no interference effect on PA.835 turbidity chyle had negative interference effect on PA.The dosage-effect experiments of 5 concentration series results showed that turbidity chyle produced linear negative interference effect on PA.Conclusions The method according to CLSI EP7-A2 document is a very practical assay for interference test in clinical chemistry with the interference reagent kits on market and medical statistical software.