改良后的长春恒晓脂蛋白相关磷脂酶A2活性检测试剂性能验证

Performance Verification of Improved Lipoprotein-associated Phospholipase A2 Detection Reagent of Changchun Hengxiao Co.,Ltd.

目的评价改良后的长春恒晓脂蛋白相关磷脂酶A2(Lp-PLA2)活性检测试剂在Beckman AU5800自动生化分析仪上的分析性能。方法收集2017年9~10月北京协和医院110例患者及40例表观健康人临床检测剩余血清,分别用于Lp-PLA2方法学比对及参考区间验证。参考CLSI相关文件,评价精密度、线性范围及常见干扰(结合胆红素、游离胆红素、血红蛋白和乳糜)。结果 Lp-PLA2活性测定试剂重复性CV(%)和实验室内不精密度CV(%)分别为1.2%~4.4%和1.5%~5.1%;线性范围为40~550U/L,相关系数(r)为0.998。低Lp-PLA2活性混合血清在试验浓度内的四种干扰物(乳糜≤1 000FTU,游离胆红素≤40mg/dl,结合胆红素≤40mg/dl,血红蛋白≤8g/L)对该试剂无干扰;高Lp-PLA2活性混合血清在试验浓度内的三种干扰物(乳糜≤3 220FTU,游离胆红素≤38.2mg/dl,结合胆红素≤38.2mg/dl)对该试剂无干扰。方法学比对中回归方程的决定系数R2为0.995,相关系数(r)为0.997。该实验室初步临床评估建立的LpPLA2活性的参考区间为68~374U/L。结论改进后的Lp-PLA2活性测定试剂的基本性能明显提高。

Objective To evaluate the analytical performance of modified Changchun Hengxiao lipoprotein associated phospholipase A2（Lp-PLA2）activity reagent on the Beckman AU5800 automatic biochemical analyzer.Methods The remaining serum samples of 110 patients and 40 apparently healthy individuals were collected from September to November in 2017 at Peking Union Medical College Hospital.These samples were used for method comparison and reference interval evaluation.According to CLSI documents,the precision,linearity and common interferences（free bilirubin,conjunct bilirubin,hemoglobin and chyle）were accessed.Results The repeatability CV（%）and reproducibility CV（%）were 1.2% -4.4% and1.5%-5.1% respectively.The linear range was 40-550 U/L,the correlation coefficient（r）was 0.998.Four interferents（chyle≤ 1 000 FTU,free bilirubin≤40 mg/dl,conjugated bilirubin≤40 mg/dl,hemoglobin ≤8 g/L）with low Lp-PLA2 mixed serum had no interference.High level of Lp-PLA2 mixed serum had no interference with the three interferences（chylomicrons≤3 220 FTU,free bilirubin≤38.2 mg/dl,conjugated bilirubin ≤38.2 mg/dl）.The determination coefficient R2 was 0.995,and the correlation coefficient（r）was 0.997 in method comparison.The reference interval of Lp-PLA2 activity established by laboratory was 68-374 U/L.Conclusion The performance of the improved Lp-PLA2 activity reagent were significantly improved.