金标免疫层析法检测恙虫病抗体的效果测评

Effect evaluation of colloidal gold immunochromatographic assay for tsutsugamushi antibody detection

目的对新开发的恙虫病金标试剂做特异性和敏感性的效果测评。方法采用微量间接免疫荧光试验(IFA)检测发热患者血清的恙虫病IgG抗体,然后选取阴性及强阳性血清共242份,用3种金标免疫层析试剂条检测恙虫病东方体IgM、IgG和总抗体。在对照成立的情况下,观察检测线的反应情况,以出现红色条带判为阳性,再用统计学方法进行分析。结果金标免疫层析法检测恙虫病IgM、IgG和总抗体的敏感性分别为62.25%、30.12%和93.98%,特异性分别为98.11%、98.74%和96.23%,与IFA比较的统计学结果分别为P<0.05、P<0.05和P>0.05。结论 IgG和IgM抗体试剂条的检测结果与IFA检测结果差异有统计学意义;总抗体试剂条的检测结果与IFA检测结果差异无统计学意义,可替代IFA检测恙虫病抗体。

Objective To evaluate the specificity and sensitivity of the newly developed colloidal gold reagent for tsutsugamushi antibody detection.Methods A micro-indirect immunofluorescent assay（IFA） was performed to measure the tstsugamushi IgG antibody level in the serum samples of febrile patients,and 242 negative and strongly positive serum samples were drawn for determination of IgM,IgG and total antibody levels of Orientia tsutsugamushi using three colloidal gold reagent strips.If the control group was eligibly founded,the presence of red bands was indicative of positive results.Statistical analysis of the above results was then conducted.Results The sensitivity of the colloidal gold immunochromatographic assay for tsutsugamushi IgM,IgG and total antibody was 62.25%,30.12% and 93.98%,respectively;the specificity was 98.11%,98.74% and 96.23%,respectively.The results of IgM and IgG levels were statistically different from the IFA measurements,whereas that of total antibody was not（P〈0.05,P〈0.05 and P〉0.05,respectively）.Conclusion Statistically significant differences were shown between the results of IgG and IgM antibody reagent strips and that of the IFA,whereas no significant difference was shown between the results of total antibody.Therefore,the newly developed assay could be a substitute for the IFA in tsutsugamushi antibody detection.