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[用于检测兔热病患者体内抗体的实验性和商业性血清学检测的比较研究。]

[A comparative study of experimental and commercial serological tests for detection of antibodies in humans with tularemia.].

作者信息

Gorbatov A A, Soloviev P V, Baranova E V, Titareva G M, Kulikalova E S, Biketov S F, Mazepa A V

机构信息

State Research Center for Applied Microbiology and Biotechnology, 142279, Obolensk, Moscow Region, Russian Federation.

Irkutsk Antiplague Research Institute of Siberia and Far East, 664047, Irkutsk, Russian Federation.

出版信息

Klin Lab Diagn. 2018;63(10):630-635. doi: 10.18821/0869-2084-2018-63-10-630-635.

DOI:10.18821/0869-2084-2018-63-10-630-635
PMID:30768885
Abstract

Experimental serological tests were developed to determine anti-tularensis antibodies in humans in immunochromatography formats (LF-test LPS Ft15) and enzyme immunoassay (ELISA LPS Ft15) using as an antigen highly purified LPS F. tularensis 15 NIIEG. Analysis was conducted of the sensitivity and specificity of the developed tests and commercial tularemia antigen «RNGA-Tul-AG» (production Stavropol research anti-plague Institute) in comparison with the commercial reference antigen, registered in the Russian Federation for the quantitative determination of human IgG tularemia - «ELISA classic Francisella tularensis IgG» SERION, Germany (IgG SERION ELISA). A study of human blood serum vaccinated against tularemia showed that the sensitivity and specificity of detection of anti-tularemia antibodies by «ELISA LPS Ft15» were 97.7 and 100%, compared with «ELISA IgG series». When determining antitularemia antibodies with the diagnosis «LF-test LPS Ft15», these parameters were compared to «ELISA IgG series» 94.3 and 100%. The sensitivity and specificity of «RNGA-Tul-AG» made compared to the «IgG ELISA, SERION» of 59.1% and 80%.

摘要

开发了实验性血清学检测方法,以免疫层析法(LF-检测LPS Ft15)和酶免疫测定法(ELISA LPS Ft15)测定人体中的抗土拉弗朗西斯菌抗体,使用高度纯化的土拉弗朗西斯菌15 NIIEG的LPS作为抗原。对所开发检测方法和商业土拉菌病抗原“RNGA-Tul-AG”(斯塔夫罗波尔研究抗鼠疫研究所生产)与在俄罗斯联邦注册用于定量测定人IgG土拉菌病的商业参考抗原——德国SERION公司的“ELISA经典土拉弗朗西斯菌IgG”(IgG SERION ELISA)相比的敏感性和特异性进行了分析。一项针对接种土拉菌病疫苗的人血清的研究表明,与“ELISA IgG系列”相比,“ELISA LPS Ft15”检测抗土拉菌病抗体的敏感性和特异性分别为97.7%和100%。在用“LF-检测LPS Ft15”诊断抗土拉菌病抗体时,与“ELISA IgG系列”相比,这些参数分别为94.3%和100%。与“IgG ELISA,SERION”相比,所制备的“RNGA-Tul-AG”的敏感性和特异性分别为59.1%和80%。

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