[1]谢正媛,陈涓涓,祖维磊,等.日本积水公司血浆全程C-反应蛋白胶乳免疫比浊法最低检测限和功能灵敏度的确认[J].现代检验医学杂志,2019,34(03):118-120.[doi:10.3969/j.issn.1671-7414.2019.03.029]
　XIE Zheng-yuan,CHEN Juan-juan,ZU Wei-lei,et al.Confirmation of the Limit of Detection and Functional Sensitivityfor the Nanopia CRP Reagent of Sekisui Medical Technology[J].Journal of Modern Laboratory Medicine,2019,34(03):118-120.[doi:10.3969/j.issn.1671-7414.2019.03.029]
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日本积水公司血浆全程C-反应蛋白胶乳免疫比浊法最低检测限和功能灵敏度的确认()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第34卷
期数:
2019年03期
页码:
118-120
栏目:
研究简报·实验技术
出版日期:
2019-06-20

文章信息/Info

Title:
Confirmation of the Limit of Detection and Functional Sensitivityfor the Nanopia CRP Reagent of Sekisui Medical Technology
文章编号:
1671-7414(2019)03-118-03
作者:
谢正媛; 陈涓涓; 祖维磊; 李奕晓; 李 欣; 孙 虹
(云南省人口和计划生育科学技术研究所西部孕前优生重点实验室 云南省生育调节与少数民族优生重点实验室,昆明 650021)
Author(s):
XIE Zheng-yuan; CHEN Juan-juan; ZU Wei-lei; LI Yi-xiao; LI Xin; SUN Hong
(Institute ofPopulation and Family Planning Science and Technology of Yunnan Province/KeyLaboratory of Pre-pregnancy Eugenics in Western China/Key Laboratory of FertilityRegulation and Excellent Birth of Ethnic Minorities in Yunnan Province,Kunming 650021,China)
关键词:
C-反应蛋白;  超敏C-反应蛋白;  检测低限;  功能灵敏度
分类号:
R446.112
DOI:
10.3969/j.issn.1671-7414.2019.03.029
文献标志码:
A
摘要:
目的 对日本积水医疗株式会社全程CRP检测试剂盒的最低检测限和功能灵敏度进行确认。方法 参照相关文献,用日本积水医疗株式会社全程C-反应蛋白检测试剂盒和雅培生化分析仪对空白样本和系列稀释的低浓度样本进行C-反应蛋白检测,计算吸光度均值、标准差和变异系数,确定该方法的检测低限和功能灵敏度。结果 日本积水医疗株式会社全程C-反应蛋白检测试剂盒的最低检测限0.21 mg/L,功能灵敏度0.27 mg/L。结论 各实验室进行hs-CRP检测时,应自行建立所用方法的最低检测限和功能灵敏度,以保证检测结果能够满足临床对心血管疾病危险评估的需要。
Abstract:
Objective To determine the limit of detection and functional sensitivity for the Nanopia CRP reagent of Sekisui Medical Technology.Methods According to previous literatures,the high-sensitivity CRP of the control and serial diluted low concentration samples were tested by ARCHITECT(Clinical)Chemistry Analyzer and the Nanopia CRP reagentof Sekisui Medical Technology.The average,standard deviation and coefficientof variation of absorption were calculated to determine the limit of detectionand functional sensitivity of this test method.Results The Nanopia CRP reagent of Sekisui Medical Technology had a detection limit of 0.21 mg/L and a functional sensitivity down to 0.27mg/L.ConclusionWhen the high-sensitivity C-reactive protein(hs-CRP)test is conducted by each individual laboratory,it is recommended to measure the limit ofdetection as well as the functional sensitivity based on the method used in each laboratory.

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备注/Memo

备注/Memo:
基金项目:云南省重点实验室自选项目(ZDsys2013001); 国家卫生健康委员会重点实验室开放项目(ZDsys2016003)。 作者简介:谢正媛(1987-),女,硕士研究生,助理研究员,主要从事临床检验、不孕不育、优生优育等生殖医学相关的研究,E-mail:xiezhengyuan11@163.com。 通讯作者:孙 虹(1963-),女,学士,主任医师,主要从事临床生化免疫检验和实验室质量管理工作,E-mail:sunhong010@sina.com。 收稿日期:2017-11-19 修回日期:
更新日期/Last Update: 2019-06-20