双抗原夹心酶联免疫试验检测布鲁杆菌病患者方法的评价研究

The Study on Evaluation of the Double Antigen Sandwich Enzyme Immunoassay for the Detection of Specific Antibodies in Brucellosis Cases

[目的]在检测不同临床期的布病患者时,评价布鲁氏菌双抗原夹心酶免疫试验(DAgS-ELISA)真实性和诊断效能。[方法]采用病例对照的实验研究方法,布鲁氏菌试管凝集试验(SAT)为标准,比较DAgS-ELISA、快速双抗原夹心ELISA(QDAgS-ELISA)、虎红平板凝集试验(RBPT)、补体结合试验(CFT)以及间接酶联免疫试验(I-ELISA)5种血清学筛检方法。[结果]应用以上5种方法同时检测急性期病例组和对照组血清,DAgS-ELISA的总一致性和约登指数最高,为96.49%和93.44%,其假阴性率最低为2.27%,U检验显示DAgS-ELISA与CFT、Ⅰ-ELISA灵敏度差异有统计学意义(P<0.05),CFT诊断效能最高,为100.00%。对慢性期布病患者和对照组血清进行检测,QDAgS-ELISA、RBPT、Ⅰ-ELISA灵敏度均为100.00%,DAgS-ELISA为93.33%,CFT为40%,U检验显示DAgS-ELISA与RBPT、Ⅰ-ELISA灵敏度间差异无统计学意义(P>0.05),而与CFT间差异有统计学意义(P<0.05)。DAgS-ELISA与Ⅰ-ELISA、CFT间特异度差异有统计学意义(P<0.05)。[结论]以SAT方法为金标准,DAgS-ELISA方法在检测急性期布病患者时,其敏感度高、特异度强、一致性均较好。

[Objective]In order to evaluate the facticity and diagnostic power of the double antigen sandwich enzyme linked absorbent assay（DAgS-ELISA）in detecting Brucellosis cases of different clinical phases. [Methods]Case control study is applied in this study. To compare with SAT method,which is the standard diagnosis for Brucellosis,the same serum specimen of human is tested by 5 different serum methods,such as the DagS-ELISA,the Brucellosis serum agglutina- tion test （SAT） , complement fixation test （CFT）,Rose Bengal Plane Test （RBPT） and Indirect ELISA test （1-ELISA）, and to compare their sensitivity and predictive value, positive rate in different clinical stage,then evaluate the facticity and diagnostic power of 5 methods mentioned above. [Results]To detect simultaneously serum specimen of the cases in acute stage and the control, the agreement ratio and Youden index of DAgS-ELISA is respectively 96.49% and 93.44%, the false negative rate is 2.27 %. There is significant deviation in sensitivity through U test at α= 0.05 level, which suggest the sensitivity of DAgS-ELISA method is higher than CFT and I-ELISA. In chronic stage,The sensitivity of QDAgS-ELISA, RBPT and 1-ELISA are all 100% ,DAgS-ELISA 93.33% ,CFT 40%. When the DAgS-ELISA method is comparcd with the RBPT and I -ELISA in sensitivity, there is no significant deviation through U test at α= 0.05 level, compared with CFT, there is significant deviation through U test （ P = 0.05）. In the specificity, there is significant difference between DAgS-ELISA and 1-ELISA method through U test at α = 0.05 level（ P 〈0.05）. [Conclusion]The study of experiment and application on-the-spot indicate that the DAgS-ELISA is superior to the other methods such as RBPT, CFT and 2- ELISA in different clinical stage,especially in the acute stage.