[1]张 磊a,李德涛a,朱 艳a,等.6 种化学发光系统检测肿瘤标志物的应用评估分析[J].现代检验医学杂志,2020,35(02):88-91.[doi:10.3969/j.issn.1671-7414.2020.02.025]
 ZHANG Leia,LI De-taoa,ZHU Yana,et al.Methodological Evaluation of Six Chemiluminescence DetectionSystems for Tumor Markers[J].Journal of Modern Laboratory Medicine,2020,35(02):88-91.[doi:10.3969/j.issn.1671-7414.2020.02.025]
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6 种化学发光系统检测肿瘤标志物的应用评估分析()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第35卷
期数:
2020年02期
页码:
88-91
栏目:
研究简报·实验技术
出版日期:
2020-05-24

文章信息/Info

Title:
Methodological Evaluation of Six Chemiluminescence DetectionSystems for Tumor Markers
文章编号:
1671-7414(2020)02-088-04
作者:
张 磊a 李德涛a 朱 艳a 甄乾娜b
(重庆医科大学附属第一医院 a. 医学检验科;b. 内分泌实验室,重庆 400016)
Author(s):
ZHANG Leia LI De-taoa ZHU Yana ZHENG Qian-nab
( a. Department of Clinical Laboratory; b. Department of Endocrine Laboratory, the First Affiliated Hospital ofChongqing Medical University, Chongqing 400016, China)
关键词:
肿瘤标志物化学发光法方法学评估
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2020.02.025
文献标志码:
A
摘要:
目的 探讨6 种化学发光系统检测甲胎蛋白(AFP)、癌胚抗原(CEA)、总前列腺特异抗原(tPSA)、游离前列腺特异性抗原(fPSA)、糖类抗原CA199(CA199)、糖类抗原CA153(CA153)和糖类抗原CA125(CA125)仪器参数、西格玛值(σ)、可比性及临床可接受程度。方法 收集6 种系统的检测速度,试剂仓位,开展项目数等硬件参数,使用单位半年质控数据,计算各系统检测项目的精密度及σ 值。以Roche E602 电化学发光系统为参考系统,根据EP9-A2 文件的要求,对检测结果进行方法比对和偏倚评估。结果 ① 比较6 种检测系统的检测速度,试剂仓位,软件功能等参数,6 种检测系统基本满足临床需求。② Roche E602 与A厂家比较,多数检测项目σ 值多数高于6σ 水平;B,D 和E 三家厂家检测项目σ 值基本处于优秀水平(5~6);C 厂家多个项目小于4σ 水平,存在较大差距。③除B厂家外,其它厂家与Roche E602 多数项目偏移超过1/2 TEa,临床不可接受。结论 实验室同时存在多种不同品牌化学发光检测系统检测同一检验项目时,应进行方法比对和偏倚评估,判断其临床可接受性能,以保证检验结果的可比性。

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:张磊(1983-),男,硕士,主管检验师,主要研究方向为临床生化和实验室管理,E-mail:285675443@qq.com。通信作者:甄乾娜,Tel:023-89011686。收稿日期:2019-11-03 修回日期:2020-01-29
更新日期/Last Update: 2020-04-30