用CLSI EP方案评价总胆红素试剂分析性能

Evaluation of the analytical performance of total bilirubin (TBil) reagents with CLSI method evaluation guidline

目的通过应用CLSI EP方案分别对国产和进口总胆红素(TBil)试剂的分析性能评价,了解国产总胆红素试剂分析性能能否满足临床需要。方法在同一台全自动生化分析仪上,同时测定试剂准确度、精密度、最低检测限、线性范围、干扰试验、方法比对实验、稳定性观察等7项技术指标。结果两种试剂准确度测定,其相对偏差≤±10%;批间变异系数<4.0%;国产TBil试剂线性范围0.5～865.0μmol/L,进口试剂线性范围0.4～869.0μmol/L;国产TBil试剂的最低检测限为0.5μmol/L,进口试剂的最低检测限为0.4μmol/L;方法比对实验结果Y=1.0069X+0.9366,R2=0.9993;抗干扰能力无明显差异;试剂稳定性相近。结论国产总胆红素试剂与进口试剂的分析性能差异无统计学意义,能满足临床实验室的需要。

Objective Through evaluate the analytical performance of domestic total bilirubin （TBil） reagents and im- posed WAKO total bilirubin （TBil） reagents,undemtanding the performance differences of domestic and imported WAKO TBiL reagents. Methods On the same automatic biochemical analyzer, determinate the reagents＇ analytical performance at the same time, such as accuracy, precision, minimum detection limit,linear range, anti-interference abiliy, stability, method comparison. Results Determinate accurate of the two reagents, the relative deviasion ≤± 10% ;the within run coefficient of variation ≤4.0% ; The linear range of self-made TBil reagent is 0.5 - 865.0p.mol/L,and the linear range of impored reagent is 0.4 - 869.0panol/ L; The minimum detection limit of domestic TBil reagents was 0.5 μmol/L, of the import reagents was 0.4μmoL/L; the result of the method comparation was Y = 1. 0069X＋0. 9366, R2 = 0.9993 ; there was no significant difference with anti-interference ability ; the two reagents had similar stability. Conclusion There was no significant difference of analytical performance with self-made total bilirnbin （TBil） reagents and imported WAKO total bilirubin （TBil） reagents.