基于AFP+AFP-L3+PIVKA-Ⅱ的电泳荧光仪性能分析

doi:10.13438/j.cnki.jdzk.2019.04.013

吉首大学学报（自然科学版）

基于AFP+AFP-L3+PIVKA-Ⅱ的电泳荧光仪性能分析

邢晏，冯长焕，杜利君

（1.西华师范大学数学与信息学院，四川南充 637000；2.南充市中心医院医学检验科，四川南充 637000）

出版日期:2019-07-25 发布日期:2019-07-31
通讯作者: 冯长焕（1972—）,女,四川南充人,西华师范大学数学与信息学院教授,硕士生导师,主要从事应用数理统计研究.
基金资助:
西华师范大学基本科研项目（14C004);南充市社科规划一般规划项目（NC2013B027）

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

XING Yan, FENG Changhuan, DU Lijun

(1. School of Mathematics and Information, China West Normal University, Nanchong 637000, Sichuan China; 2. Department of Medical Laboratory, Nanchong Central Hospital, Nanchong 637000, Sichuan China)

Online:2019-07-25 Published:2019-07-31

摘要/Abstract

摘要：

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.

关键词： 电泳荧光免疫分析仪, AFP, PIVKA-Ⅱ, 性能验证

Abstract:

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.

Key words: electrophoretic fluorescence immune-analyzer, AFP, PIVKA-Ⅱ, performance verification

邢晏，冯长焕，杜利君. 基于AFP+AFP-L3+PIVKA-Ⅱ的电泳荧光仪性能分析[J]. 吉首大学学报（自然科学版）, DOI: 10.13438/j.cnki.jdzk.2019.04.013.

XING Yan, FENG Changhuan, DU Lijun. Performance Verification and Analysis of Electrophoretic Fluorimeter Based on AFP, AFP-L3 and PIVKA-Ⅱ[J]. Journal of Jishou University（Natural Sciences Edition), DOI: 10.13438/j.cnki.jdzk.2019.04.013.

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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

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