国产化学氧化法(综合氧化剂)测胆红素试剂盒的质量评估

An Evaluatian for Chinese Kit of Bilirubin Assay by Chemical Oxidation Method

目的 评价化学氧化法 (综合氧化剂 )测定血清中总胆红素和直接胆红素。方法 通过测定精密性、准确性、各种干扰和与钒酸试剂法的相关试验。结果 总、直胆精密度分别为批内 CV1 .0 1 %与3 .2 4 % ,日间 CV为 1 .5 8%与 2 .3 1 % ;平均回收率总胆为 1 0 0 .8% ,直胆为 1 0 4 .5 % ,与日本钒酸氧化法共测 40例相关性为 :总胆 Y(综 ) =1 .0 5 X(钒 ) - 2 .5 3 ,r=0 .9992 ;直胆 Y(综 ) =1 .1 9X(钒 ) - 4.5 6 ,r=0 .9985。Hb浓度 <3 0 0 mg/dl,脂血在 Intralipos指数 5以下不受干扰。结论 该法简单、快速、稳定、完全适应临床使用。

Objective Evaluation for chemical oxidation method measuring bilirubin.Methods The accuracy and precision,as well as interference experiment were made.The correlation analysis of chemical oxidation and vanadic oxidation methods also were made.Results The CV of determination total and direct bilirubin was 1.01%and 3.24%,between day was 1.58%and 2.31% respectively. The average recovery was 100.8% and 104.5% for total and direct bilirubin.The result of the method correlation well with vanadic method.Their's regression equation and r value were:TBIL Y (Complex)=1.05 X (Vanadic)-2.53, r =0.999 2,DBIL Y (Complex)=1.19 X (Vanadic)-4.56, r =0.998 5.Hb concentration<300mg/dl and Lipimia <5 intralipos no interference was observed.Conclusion The method is single,rapid and stable,can be widely used in clinical area.