低成本建立甲胎蛋白临床可报告范围  

The Establishment of the Clinical Reportable Range for the Detection of AFP with Low Cost by CMIA

作　　者：宋秦伟 王娅琳[1] 张易 刘智圆 马丽娟[1] SONG Qinwei;WANG Yalin;ZHANG Yi;LIU Zhiyuan;MA Lijuan(Department of Clinical Laboratory, Children′s Hospital Capital Institute of Pediatrics, Beijing 100020, China)

机构地区：[1]首都儿科研究所附属儿童医院检验科,北京100020

出　　处：《标记免疫分析与临床》2020年第11期2007-2010,共4页Labeled Immunoassays and Clinical Medicine

基　　金：北京市医院管理局“青苗”计划专项基金(编号:QML20171304)。

摘　　要：目的建立可降低检测成本的化学发光微粒子免疫检测法(CMIA)检测血清甲胎蛋白(AFP)的临床可报告范围(CRR)。方法按照ISO15189要求,参考美国临床实验室标准化协会(CLSI)相关文件,在化学发光分析仪上进行AFP的分析测量线性范围(AMR)验证试验,建立其临床可报告范围(CRR),并验证浓缩清洗缓冲液用去离子水1∶9稀释后作为样本稀释液与配套专用样本稀释液(多项目手工稀释液)具有相同效果。结果AFP的AMR为2.32~1825.95ng/mL,允许最大手工稀释度为801倍,CRR为2.32~1462585.95ng/mL;两种稀释液检测结果偏倚均小于1/3 TEa(25%),均可接受。结论AFP临床可报告范围的建立,对于高值病例的检测和监测有重要意义,能够满足临床需求;浓缩清洗缓冲液1∶9稀释后作为样本稀释液与配套专用样本稀释液具有一致效果,可降低稀释检测成本。Objective To establish the clinical reportable range(CRR)of serum alpha fetoprotein(AFP)with low detection cost by chemiluminescent microparticle immunoassay(CMIA).Methods According to the requirements of ISO15189 and referring to the relevant documents of American Society for clinical laboratory standardization(CLSI),the analytical measurement range(AMR)verification test of AFP was conducted on Abbott i2000sr chemiluminescence analyzer to establish a clinical reportable range(CRR).We compared the effect of the concentrated cleaning buffer diluted with deionized water in 1∶9 as the sample diluent and the matched special sample diluent(the multiple items manual diluent).Results The AMR of AFP was 2.32-1825.95ng/mL,the maximum allowable manual dilution was 801 times,and the CRR was 2.32-1462585.95ng/mL.The bias of test results with the two types of diluents was less than 1/3TEa(25%),which was acceptable.Conclusion The establishment of the clinical reportable range of AFP is of great significance for the detection and monitoring of high-value cases,which could meet the clinical needs.The concentrated cleaning buffer diluted with deionized water in 1∶9 as the sample diluent has the same effect as the matched special sample diluent,which could reduce the cost of dilution test.

关 键 词：甲胎蛋白 临床可报告范围 化学发光微粒子免疫检测法 

分 类 号：R-331[医药卫生]