国产酶联免疫试剂检测登革热效能评价  

Evaluation of the effectiveness of a domestic enzyme-linked immunosorbent assay to detect dengue fever

作　　者：李要星 杨爽[2] 李娜 郭晓芳[4] 杨恒林[4] LI Yao-xing YANG Shuang LI Na GUO Xiao-fang YANG H eng-lin(Laboratory, The First Peoplgs Hospital of Qujing, Yunnan Province, Qujing 655000, Yunnan, China Department of Rehabilitation, Kunming Municipal Hospital of Traditional Chinese Medicine Institute of Pathogens and Vectors, Dali University Yunnan Institute of Parasitic Diseases, Yunnan Center of Malaria Research)

机构地区：[1]曲靖市第一人民医院生物实验室,云南曲靖655000 [2]昆明市中医医院康复科 [3]大理大学病原生物研究所,云南大理671003 [4]云南省寄生虫病防治所,云南省疟疾研究中心,云南普洱665000

出　　处：《中国病原生物学杂志》2017年第5期434-436,共3页Journal of Pathogen Biology

基　　金：云南省惠民科技计划项目(No.2016RA010);上海市2015年度“科技创新行动计划”国内合作项目(No.15495800400)

摘　　要：目的评价我国研制的酶联免疫试剂检测登革热病毒的效能,推进国产登革热检测剂的研发。方法采用我国研制的酶联免疫试剂对已知登革热NS1阳性血清和阴性血清进行检测,对已知阳性血清中检测阴性的血清和已知阴性血清中检测阳性血清进行PCR扩增,以排除假阴性或假阳性。根据检测结果,计算阳性符合率(真阳性率)、阴性符合率(真阴性率),进行配对资料的χ2检验,对试剂盒的灵敏度和特异性等进行综合评估。结果国产酶联免疫试剂检测已知登革热患者血清108份均阳性,阳性符合率(真阳性率)为100%,假阴性率为0。检测139份已知阴性血清,其中127份阴性,12份阳性(核酸检测为阴性),阴性符合率(真阴性率)为91.37%,假阳性率为8.63%。检测15份干扰标本均阴性,干扰标本符合率为100%。国产酶联免疫试剂与美国NS1试剂盒检测的总符合率为95.14%,两种方法的检测结果差异有统计学意义(χ~2=4.6,P<0.05)。结论国产酶联免疫试剂检测登革热的灵敏度高,但特异性较美国NS1试剂盒差。Objective To evaluate the performance of a domestic enzyme-linked immunosorbent assay （ELISA） kit in the detection of dengue virus in China. Methods Sera samples that were known to be positive for dengue NS1 and nega- tive sera were tested using a domestically produced ELISA kit. Both types of sera were tested using PCR. A χ^2 test was used to compare the sensitivity and specificity of the kit to the positive concordance rate （true positive rate） and the negative concordance rate （true negative rate） for the kit. Results One hundred and eight sera samples all tested positive for dengue fever with a positive rate （true positive rate） of 100% and a false negative rate of 0%. Of 139 sera samples that were known to be positive for dengue fever, 127 tested negative and 12 tested positive （nucleic acids were not detected）. The negative concordance rate （true negative rate） was 91.37% and the false positive rate was 8.63%. Fifteen interference samples tested negative, with a concordance rate of 100%. The total concordance rate for the domestic ELISA kit and the American NS1 kit was 95. 14%. The two kits differed significantly in terms of performance （χ^2= 4. 3, P〈0.05）. Conclusion A domestic ELISA kit has a higher level of sensitivity but a lower level of specificity in detecting dengue fever than an American NS1 kit had.

关 键 词：登革热 登革病毒 酶联免疫反应 灵敏性 特异性 

分 类 号：R373.33[医药卫生—病原生物学]