基于AFP+AFP-L3+PIVKA-Ⅱ的电泳荧光仪性能分析

Performance Verification and Analysis of Electrophoretic Fluorimeter Based on AFP, AFP-L3 and PIVKA-Ⅱ

随机选择南充市某三甲医院门诊体检患者,参照美国临床实验室标准化协会(CLSI)EP-6A2文件,结合甲胎蛋白(AFP)及其异质体比率(AFP-L3)与异常凝血酶原(PIVKA-Ⅱ)试剂分析验证了全自动电泳荧光免疫分析仪μTASWakoi30的精密度、线性范围、准确性性能.结果表明,μTASWakoi30精密度CV均在10%以下,完全满足标准要求;AFP及PIVKA-Ⅱ在高值样本不同比例下通过实测均值与预测值回归拟合均线性良好;在不同校准品比和不同质量浓度水平下,回收率均在要求范围80%~120%内,准确性高.

Outpatients in a 3A (Grade A) Hospital in Nanchong City have been randomly selected.According to the EP-6A2 document announced by CLSI,the precision,linear range and accuracy of μTASWakoi30 have been verified by combining alpha-fetoprotein (AFP) and its heterogeneity ratio (AFP-L3) with abnormal prothrombin (PIVKA-Ⅱ) reagent specification.The results showed that the precision CV of μTASWakoi30 was below 10%,and the precision of AFP and PIVKA-Ⅱ were all below 10%,and AFP and PIVKA-Ⅱ were fitted well by the regression of mean value and predicted value in different proportion of high value samples.The recoveries were within 80%~120% at different calibration levels and the accuracy was high.