鼠疫菌F1抗体/抗原酶联免疫诊断试剂盒的应用评价

目的对兰州生物制品研究所有限责任公司研制的鼠疫菌F1抗体酶联免疫诊断试剂盒和鼠疫菌F1抗原酶联免疫诊断试剂盒进行临床应用评价。方法采用双抗原/抗体夹心酶联免疫吸附试验(ELISA)、间接血球凝集试验(IHA)、胶体金免疫层析试验(GICA)3种方法的诊断试剂对比检测云南省地方病防治所中心实验室保藏的和现场采集的血清样品和脏器样品,对血清样品做鼠疫菌F1抗体检测,对脏器样品做鼠疫菌F1抗原检测。结果在358份血清样品中,ELISA试剂检出F1抗体阳性52份(14.52%),IHA试剂检出阳性37份(10.34%),GICA试剂检出阳性45份(12.57%)。ELISA与IHA试剂的符合率为95.23%,与GICA试剂的符合率为96.92%。经统计学χ2检验,ELISA试剂检出F1抗体阳性率高于IHA试剂(χ2=11.53,P=0.000 7),与GICA试剂检出的差异无统计学意义(χ2=3.27,P=0.070 4)。进一步分析滴度差值频数,ELISA试剂检测人血清的敏感性高于IHA试剂的样品占87.5%。在117份脏器样品中,3种试剂均检出F1抗原阳性15份(12.82%),符合率100%。滴度差值频数比较,ELISA试剂检测敏感性高于反向间接血球凝集试验(RIHA)试剂的样品为78.57%。结论兰州生物制品研究所有限责任公司研制的鼠疫菌F1抗体酶联免疫诊断试剂盒和鼠疫菌F1抗原酶联免疫诊断试剂盒性质特异,其敏感性优于IHA试剂盒和GICA试剂条,值得在鼠疫的监测和快速诊断中推广应用。

Clinical evaluation of ELISA kit for antibody and antigen of Yersinia pestis F1

Objective To evaluate two kinds of ELISA kits in detection of Yersinia pestis F1 antibody and antigen, respec- tively, which were developed and manufactured by Lanzhou Institute of Biological Products Co, Ltd（LIBP）. Methods The samples, which previously stored in the laboratory or recently collected from the trial sites, were detected for Yersinia pestis antibody/antigen with 3 kinds of reagents and methods （ double antigen and double antibody sandwich enzyme-linked immu- nosorbent kit （ELISA）, indirect hemaglutination assay kits （IHA/RIHA）, and gold immune-chromatography assay strips （GICA） ）. The sera samples were tested for the specific F1 antibody. The samples of internal organ were tested for the spe- cific F1 antigen. Results A total of 358 sera samples were tested for the specific F1 antibody. The numbers of positive sam- pies are 52 （14.52%）, 37 （10.34%）, and 45 （12.57%） confirmed with ELISA, IHA, and GICA, respectively, the coin- cidence rate between ELISA and IHA is 95.23%, between ELISA and GICA is 96.92%. Through chi-square test, ELISA is superior to IHA in detecting F1 antibody （χ2 = 11. 53, P = 0.000 7）, it showed no statistically significant difference （χ2= 3.27, P=0.070 4） with GICA. According to comparison for the drop degree difference frequency, the ELISA kit exhibited a sen- sitivity higher than that of IHA kit on 87.5% human sera speci- mens. A total of 116 viscera suspensions and 1 rat bone marrowimmersion sample were tested for the specific F1 antigen. In detecting F1 antigen, three reagents and methods presented the same results, being confirmed as positive with the same 15 samples （ 12.82% ）. The coincidence rate of EL1SA compared with IHA and GICA are 100%. According to comparison for the drop degree difference frequency, the ELISA kit exhibited a sensitivity higher than that of RIHA kit on 78.57% human sera specimens. Conclusion Two kinds of ELISA kits in detec- tion of Yersinia pestis F1 antibody and antigens developed by LIBP are specific,