卡他莫拉菌胶体金免疫层析试纸的性能评估  

Performance Evaluation of Immunochromatographic Colloidal Gold Test Strips for Detecting Moraxella catarrhalis

作　　者：程雨洁 侯昊 王毅 杨波[1,2,3] 胡征 CHENG Yujie;HOU Hao;WANG Yi;YANG Bo;HU Zheng(School of Food and Biological Engineering,Hubei University of Technology,Wuhan 430068;Key Lab.of Fermentation Engineering,Ministry of Education,Hubei University of Technology,Wuhan 430068;Hubei Collaborative Innovation Center for Industrial Fermentation,Wuhan 430068)

机构地区：[1]湖北工业大学生物工程与食品学院,湖北武汉430068 [2]湖北工业大学发酵工程教育部重点实验室,湖北武汉430068 [3]工业发酵湖北省协同创新中心,湖北武汉430068

出　　处：《中国医药工业杂志》2021年第10期1356-1360,共5页Chinese Journal of Pharmaceuticals

基　　金：湖北省科技厅自然科学青年基金(2017CFB226)。

摘　　要：对自研的卡他莫拉菌胶体金试纸的性能进行检测。随机抽取试纸,与呼吸道常见病原菌进行交叉反应检测其灵敏度,考察内源外源干扰物对试纸的干扰作用,以及检测试纸是否存在钩状效应和批次间试纸的贮存稳定性。结果显示,制备的卡他莫拉菌胶体金免疫层析试纸检测灵敏度为3.25×10^(4) CFU/ml;对呼吸道其他常见22种病原体均无交叉反应;可稳定保存一年半以上;在菌浓度为1.0×10^(7)~1.0×10^(9) CFU/ml时,不存在钩状效应;内源和外源干扰物均没有对检测结果产生干扰反应。试纸的准确性、灵敏度及稳定性满足批量生产要求,符合体外诊断试剂产品的注册要求。The performance of self-developed immunochromatographic colloidal gold test strips for detecting Moraxella catarrhalis was tested.Test strips were selected randomly and cross-reacted with common respiratory pathogens to detect their sensitivity.In addition,the interference effects of internal and external interferences,hook effect of the test strips and storage stability of the test strips between batches were also tested.The results showed that the immunochromatographic colloidal gold test strips for detecting Moraxella catarrhalis had a detection sensitivity of 3.25×10^(4) CFU/ml.The test strips had no cross-reactivity to other 22 common respiratory pathogens and could keep stable for more than one and a half years.No hook effect was observed when the bacterial concentration was 1.0×10^(7)-1.0×10^(9) CFU/ml,and neither endogenous nor exogenous interfering substances could interfere with the detection results.The accuracy,sensitivity and stability of the test strips met the requirements of mass production,as well as the registration requirements of in vitro diagnostic reagent products.

关 键 词：卡他莫拉菌 胶体金免疫层析试纸 特异性 灵敏度 钩状效应 稳定性 

分 类 号：R446.5[医药卫生—诊断学]