白色念珠菌的快速检测技术开发  

Development of rapid testing technology for Candida albicans

作　　者：石星亮 余一海 陈静 谭有将 梁德智 SHI Xingliang;YU Yihai;CHEN Jing;TAN Youjiang;LIANG Dezhi(Department of Clinical Laboratory,Shunde Beijiao Hospital,Foshan,Guangdong 528311,China;Innovative Design Institute,Foshan,Guangdong 528311,China;Musai Biotechnology Co.Ltd,Foshan,Guangdong 528311,China)

机构地区：[1]广东省佛山市顺德区北滘医院检验科,广东佛山528311 [2]广东省佛山市顺德区创新设计研究院,广东佛山528311 [3]广东省佛山市顺德区墨赛生物科技有限公司,广东佛山528311

出　　处：《检验医学与临床》2020年第9期1189-1191,共3页Laboratory Medicine and Clinic

基　　金：广东省佛山市科技局医学类科技攻关项目(2017AB003183)。

摘　　要：目的利用白色念珠菌单克隆抗体建立一种快速检测临床标本中白色念珠菌的方法。方法利用免疫层析技术,采用双抗夹心法制作成检测白色念珠菌的检测卡。利用标准菌株及临床标本对检测卡的最低检测限、交叉反应进行评估。与荧光PCR核酸扩增法进行试验对比,评估其灵敏度、特异度。结果该方法的最低检测限为10^4 cfu/mL,对可能造成交叉反应的临床常见的菌株,如热带念珠菌、克柔氏念珠菌、曲霉、金黄色葡萄球菌等真菌和细菌进行检测,均无交叉反应。该检测卡的灵敏度及特异度分别为80.00%和97.00%,与荧光PCR核酸扩增法进行对比,差异有统计学意义(P<0.05),Kappa值为0.737,两种方法一致性一般。结论该研究建立了一种灵敏度、特异度、准确度较高的,能快速检测临床标本中白色念珠菌的方法,对于有临床症状而快速检测结果为阴性的标本,建议进行荧光PCR核酸扩增法检测。Objective A rapid method for the detection of Candida albicans in clinical specimens was established by using monoclonal antibody for Candida albicans.Methods Using immunochromatography technology and double antibody sandwich method,a detection card for Candida albicans was made.Standard strains and clinical specimens were used to evaluate the minimum detection limit,cross-reaction of the test card.The sensitivity,specificity and statistical significance of the method were evaluated by comparing with the fluorescence PCR nucleic acid amplification method.Results The minimum detection limit of this method was 10^4 cfu/mL.There was no cross-reaction among common clinical fungi and bacteria,such as Candida tropicalis,Candida krusei,Aspergillus,Staphylococcus aureus.The sensitivity and specificity of the card were 80.00%and 97.00%respectively,comparing with the fluorescence PCR nucleic acid amplification method,the differences had statistically significant(P<0.05),the Kappa value was 0.737.The consistency between them was ordinary.Conclusion A method with high sensitivity,specificity and accuracy for rapid detection of Candida albicans in clinical specimens is established.For the specimens with clinical manifestations and negative rapid detection,it is recommended to conduct fluorescence PCR nucleic acid amplification method.

关 键 词：白色念珠菌 免疫层析技术 双抗夹心法 

分 类 号：R446.5[医药卫生—诊断学]