作者:王臣玉、陈磊、杨丽萍 烟台毓璜顶医院

【摘要】目的:通过自动化高通量POCT检测产品的产业化，在临床应用中客观比较分析传统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降钙素原结果。方法:分别采用罗氏 cobas e601电化学发光系统和上海奥普生物医药有限公司的荧光免疫定量分析系统测定141例临床样本，并对测得数据进行统计学分析。结果:两种检测方法具有很好的相关性，t=-0.230，P=0.819＞0.05;回归方程:y =，线性回归系数为1.0088，相关系数r=0.995， P=0.000，检测结果具很好的一致性。在两个医学决定水平处(PCT=0.5ng/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。

【关键词】降钙素原;荧光免疫层析法;电化学发光法;

Amethodology comparisonstudy ontwo procalcitonin analysis systems/Wang Chen-yu，Chen Lei，Yang Liping，Shi Xiaoqiang，Yang Jing，Li Fugang

【ABSTRACT】Objective:To evaluate the comparability of the test results of twoimmunoassaysystemsbased on the electrochemical luminescence and the fluorescencelateralflowimmunoassayfor serum procalcitonin (PCT).Methods:Atotal of 141 samples were detected bythe two systems to obtain the correlation coefficient and the liner equation for evaluation ofthe comparability of thetwo systems.Results:The two systems showed high correlation(y=，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 diagnostic 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.

【KeyWords】:Procalcitonin;fluorescence lateral flow immunoassay;electrochemical luminescence

【First-author's address】:Yantai Yuhuangding Hospital，Shan dong，，China

降钙素原(PCT)是由116个氨基酸组成的激素原，分子量大约为12.7kD。PCT由神经内分泌细胞(包括甲状腺、肺和胰腺组织的C细胞)表达，经酶切分解为(未成熟)降钙素、羧基端肽和氨基端肽。健康人血中仅含有少量的PCT[1，2]。细菌感染后PCT会明显升高，是细菌感染的特异性指标。PCT水平升高常见于细菌性脓毒血症，尤其是重症脓毒血症和感染性休克[3-8]。PCT可作为脓毒血症的预后指标