[1]王臣玉,杨丽萍,陈 磊,等.两种降钙素原检测系统比较实验研究[J].现代检验医学杂志,2017,32(04):143-144,147.[doi:10.3969/j.issn.1671-7414.2017.04.041]
　WANG Chen-yu,YANG Li-ping,CHEN Lei,et al.Methodology Comparison Study on Two Analysis Systems of Procalcitonin[J].Journal of Modern Laboratory Medicine,2017,32(04):143-144,147.[doi:10.3969/j.issn.1671-7414.2017.04.041]
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两种降钙素原检测系统比较实验研究()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年04期
页码:
143-144,147
栏目:
研究简报·实验技术
出版日期:
2017-07-25

文章信息/Info

Title:
Methodology Comparison Study on Two Analysis Systems of Procalcitonin
文章编号:
1671-7414(2017)04-143-03
作者:
王臣玉1; 杨丽萍1; 陈 磊1; 杨 晶2; 李福刚2; 石晓强2
1.烟台毓璜顶医院,山东烟台 264000; 2.上海奥普生物医药有限公司,上海 201201
Author(s):
WANG Chen-yu1; YANG Li-ping1; CHEN Lei1; YANG Jing2; LI Fu-gang2; SHI Xiao-qiang2
1.Yantai Yuhuangding Hospital,Shandong Yantai 264000,China; 2.Shanghai Upper BIO-TECH Pharma CO,Ltd,Shanghai 201201,China
关键词:
降钙素原;  荧光免疫层析法;  电化学发光法
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.04.041
文献标志码:
A
摘要:
目的 在临床应用中比较分析电化学发光法和新型的基于纳米微球的荧光免疫层析法测定血清降钙素原(PCT)结果。方法 以罗氏cobas e601电化学发光系统作为参比系统,上海奥普生物医药有限公司的荧光免疫定量分析系统作为待评估系统,测定2015年11月期间141例临床样本,对测得数据进行相关性分析,并在两个医学决定水平处(PCT=0.5 ng/m l和PCT=2.0 ng/ml)进行卡方检验。结果 两种检测方法具有很好的相关性(回归方程Y=1.008X-0.032,r=0.995,P<0.001)和较小的偏差(t=-0.230,P=0.819>0.05); 在两个医学决定水平处(PCT=0.5 ng/ml和PCT=2.0ng/ml)的kappa值分别为0.944和0.943。结论 基于微球的荧光免疫层析定量检测方法与电化学发光法测定PCT结果具有高度的相关性和一致性,各项指标均能达到临床检测需求,可用于临床PCT浓度的快速检测,在实时性方面优于电化学发光法。
Abstract:
Objective To evaluate the comparability of thetest results of two immunoassay systems based on the electrochemical luminescence and the fluorescence lateral flow immunoassay for serum procalcitonin(PCT).Methods Roche cobas system was used as the reference system,and fluorescence lateral flow immunoassay system of Shanghai Upper biotech company was used as evaluated system.A total of 141 clinical samples during November,2015 were detected by the two systems to obtain the correlation coefficientand the Kappa values at the two cutoff values(0.5,2.0 ng/ml).Results The two systems showed high correlation(Y=1.008X-0.032,r=0.995,P<0.001)and low deviation(t=-0.230,P=0.819>0.05)without statistic significance between two methods.Kappa values were 0.944,0.943 respectively at the two cutoff values(0.5,2.0 ng/ml).Conclusion The test results showed no significant difference between the twoimmunoassay systems,suggesting a consistency between them for clinical detection of PCT.All the observed indicators reached the clinical diagnostic requirements and the method of quantitative detection of PCT by fluorescence lateral flowimmunoassya can be applied for the quick detection of clinical human PCT.

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备注/Memo

备注/Memo:
基金项目:上海廖市科委2013年度生物医药领域成果转化和产业化项目(13DZ1942200)《自动化高通量POCT检测产品的产业化》。 作者简介:王臣玉(1964-),男,本科,副主任检验师,研究方向为临床检验与转化工作,担任门诊检验科主任,E-mail:yj@poct.cn。 通讯作者:陈 磊(1980-),男,硕士研究生,主管检验师,从事临床检验与转化工作,E-mail:clkingdom@sina.com。 石晓强(1980-),男,博士研究生,高级工程师,上海奥普生物医药有限公司研发中心总监,从事POCT开发与产业化研究,E-mail:sxq@poct.cn。
更新日期/Last Update: 1900-01-01