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=0.5ng/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.Ong/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。
Objective To evaluate the comparability of the test results of two immunoassay systems based on the electrochem- ical luminescence and the fluorescence lateral flow immunoassay for serum procalcitonin （PCT）. Methods Roche cobas sys- tem 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 coefficient and 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 two immunoassay systems, suggesting a consistency between them for clinical detection of PCT. All the observed indicators reached the clinical diagnos- tic requirements and the method of quantitative detection of PCT by fluorescence lateral flow immunoassya can be applied for the quick detection of clinical human PCT.
出处
《现代检验医学杂志》
CAS
2017年第4期143-144,147,共3页
Journal of Modern Laboratory Medicine
基金
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>
关键词
降钙素原
荧光免疫层析法
电化学发光法
procalcitonin
fluorescence lateral flow immunoassay
electrochemical luminescence
