参照CLSIEP方案评价直接胆红素试剂分析性能

目的通过应用CLSIEP方案分别对国产和进口直接胆红素（DBil）试剂分析性能进行评价，了解国产直接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％；批间变异系数小于4．0％；国产DBil试剂线性范围0．2—595．0umol／L，进口试剂线性范围-0．4—595．7umol／L；国产DBil试剂的最低检测限为0．4umoL／L，进口试剂的最低检测限为0．9umol／L；方法比对实验结果Y=0．997X＋5．2467，R^2=0．9996（浓度范围0.2—595．0umol／L）；抗干扰能力无明显差异；试剂稳定性相近。结论：国产直接胆红素试剂与进口试剂的分析性能无显著性差异，能满足临床实验室的需要。

Evaluation of the analytical performance of Direct Bilirubin (DBil) reagents according CLSI EP document

Objective Through evaluate the analytical performance of domestic Direct Biliruhin （DBil） reagents and imported WAKO Direct Biliruhin （DBLI） reagents with CLSI document, understanding performance differences of domestic and imported WAKO Direct Bilirubin. 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 ability, stability, method comparison. Results Determinate accurate of the two reagents, the relative deviation ≤ ± 10% ; the within run coefficient of variation≤4.0% ; The linear range of self- made DBii reagent is 0.2 - 595.0umol/L, and the linear range of imported reagent is- 0.4 - 595.7umol/L） ;The minimum detection limit of domestic DBil reagents was 0.4umol/L, of the import reagents was 0.9umol/L; the result of the method comparation was Y = 0.997X ＋ 5.2467, R^2 = 0.9996; there was no significant difference with anti - interference ability; the two reagents had similar stability. Conclusions There was no significant difference of analytical performance with self- made Direct Bilirubin （DBil） reagents and imported WAKO Direct Bilirubin （DBil） reagents.