单纯疱疹病毒抗原快速诊断试剂盒的制备和评价  

The Preparation and Evaluation of a Rapid Immunoassay for Direct Detection of HSV Antigen

作　　者：郦黎明 张树文 刘光明 张津萍[2] 沙仲 尤永燕 

机构地区：[1]镇江市疾病预防控制中心,江苏镇江212002 [2]中国医学科学院北京协和医科大学皮肤病研究所,江苏南京210042 [3]南京黎明生物制品有限公司,江苏南京210042

出　　处：《中国皮肤性病学杂志》2013年第8期780-782,共3页The Chinese Journal of Dermatovenereology

摘　　要：目的研制一种用于检测单纯疱疹病毒抗原的彩色乳胶免疫层析法快速诊断试剂盒,并评价其临床应用价值。方法采用彩色乳胶颗粒标记抗HSV-1和HSV-2的单克隆抗体,制成免疫层析法快速诊断试剂盒。以实时荧光定量PCR方法为对照,平行检测各种水疱、溃疡性皮损中的HSV抗原,观察该试剂盒检测的阳性符合率。结果制备出的HSV抗原快速诊断试剂盒可检出≥1.0×106DNA拷贝/mL的HSV-1病毒混悬液和5.0×105DNA拷贝/mL的HSV-2病毒混悬液,共检测临床标本456份,免疫层析法检出HSV阳性218例,PCR检出HSV阳性236例。以实时荧光定量PCR为金标准,免疫层析法的敏感性、特异性、阳性预期值、阴性预期值和准确度分别为91.9%,99.5%,99.5%,92.0%和91.4%。结论免疫层析法检测HSV感染,其敏感性和特异性高,具有方便、快速和经济的特点,尤其适合于有症状患者的即时检测,对疱疹患者的早期诊断和及时用药有重要作用。Objective A dyed latex immuno-chromatographic rapid assay was developed to detect Herpes simplex virus 1 and 2 antigen in various mucocutaneous lesions. Methods The HSV immuno-chromatographic assay was prepared with dyed latex beads coupled anti-HSV monoclonal antibodies. It was compared with Real-time PCR for detecting HSV from different mucocutaneous lesions. Results The HSV rapid test detected HSV in serial dilutions which contain more than 1.0 - 106 DNA copies/mL HSV-1 or 5.0 -10s DNA copies/mL HSV-2 infected vero cells homogenate A total of 456 clinical specimens were tested using the rapid test and the results were compared with those obtained by Real-time PCR. The sensitivity, specificity, positive and negative predictive values for the rapid test were 91.9%, 99.5%, 99.5%, 92.0%, respectively. Conclu- sions The rapid test offered an useful, rapid and cheaper method for early detecting HSV.

关 键 词：单纯疱疹病毒 免疫层析法 实时荧光定量PCR 

分 类 号：R752.1[医药卫生—皮肤病学与性病学]