3种缺血修饰清蛋白试剂盒分析性能的验证试验

目的验证3种缺血修饰清蛋白(IMA)检测试剂盒的主要分析性能。方法在Olympus AU5800全自动生化分析仪上对上海艾康生物技术有限公司、浙江夸克生物科技有限公司和北京九强生物技术有限公司的比色法IMA试剂(试剂A、B、C)进行性能验证,参考美国临床实验室标准化委员会(NCCLS)EP6-A、EP15-A、EP7-A文件和《WS/T 420-2013临床实验室对商品定量试剂盒分析性能的验证》要求对3种试剂的精密度、线性范围、正确度、抗干扰能力进行评估。结果试剂A、B、C的批内变异系数(CV)分别为0.59%~0.82%,0.27%~0.54%,0.62%~0.69%,批间CV分别为0.98%~1.74%,0.99%~1.01%,0.71%~0.78%,均小于试剂盒声明的不精密度;线性范围分别为11~142U/mL(相关系数r~2=0.993)、10~120U/mL(r~2=0.996)、14~123U/mL(r~2=0.992),试剂A、B、C的线性范围均良好。当干扰物维生素C小于或等于10mg/dL,血红蛋白小于或等于200mg/dL,总胆红素小于或等于40 mg/dL,三酰甘油小于或等于500 mg/dL时,3种IMA试剂检测结果偏差均不超过±10%,对3种试剂无明显干扰。结论 3种IMA检测试剂盒均具有较高的精密度,可满足临床要求,但抗干扰能力存在一定的差异。

Performance verification of three ischemia-modified albumin reagents

Objective To verify the performance of three kinds of ischemia‐modified albumin(IMA) reagents .Methods The performance of three IMA reagents(labeled as reagent A ,B ,C) using colorimetric method from Shanghai Aikang Biotechnology Co .,Ltd .,Zhejiang Kuake Bioscience Technology Co .ltd .and Beijing Jiuqiang Biotechnology Co .,Ltd .were assessed by using O‐lympus AU5800 automatic biochemistry analyzer .According to the National Committee for Clinical Laboratory(NCCLS) EP6‐A , EP15‐A and EP7‐A documents and WS/T 420‐2013 verificationof analytical performance of quantitative kits by clinical labo‐ratory ,the precision ,linearity range ,accuracy and anti‐interference capability were assessed .Results The within‐run coefficient of variations(CVs) of reagent A ,B and C were 0 .59% -0 .82% ,0 .27% -0 .54% and 0 .62% -0 .69% respectively .The between‐run CVs of reagent A ,B and C were 0 .98% -1 .74% ,0 .99% -1 .01% and 0 .71% -0 .78% ,respectively ,which were lower than decla‐rations of these reagent kits .The linearity range of reagent A ,B and C were 11 -142 U/mL(r2 = 0 .993) ,10 -120 U/mL(r2 =0 .996) ,14-123 U/mL(r2 =0 .992) respectively ,which showed good linearities .About interference tests ,no remarkable interfer‐ences(all Bias were less than ± 10% ) of reagent A ,B and C were detected when Vitamin C≤10 mg/dL ,hemoglobin≤200 mg/dL , bilirubin≤40 mg/dL and triglyceride≤500 mg/dL .Conclusion The three IMA reagents show high precision ,which could meet clinical requirements ,nevertheless ,differences of anti‐interference capabilities are observed in these three reagents .