布鲁氏菌4种高通量抗体检测方法的比较研究

旨在科学选择和使用布鲁氏菌抗体检测方法，推动布病诊断试剂标准化。本研究用布病阳性血清标准品测定了国家/OIE布鲁氏菌病参考实验室开发的布鲁氏菌荧光偏振（FPA）抗体检测试剂盒、动物布鲁氏菌病竞争ELSIA （cELISA）抗体检测试剂盒、牛布鲁氏菌病间接ELISA （iELISA）抗体检测试剂盒和改进的微量补体结合试验（mCFT）等4种方法的灵敏度。通过对已知阴、阳性血清样品的检测，比较了各检测方法的敏感性和特异性，并用临床样本进一步比较了各种方法检测结果的吻合性。结果表明，4种方法检测的灵敏度基本一致，当布病阳性血清标准品按1∶20稀释（即50 IU·mL^-1）时均检测为阳性，1∶40稀释（即25 IU·mL^-1）时均检测为阴性。FPA、cELISA、iELISA和mCFT方法的敏感性分别为97.14%、100.00%、100.00%、98.57%，特异性分别为96.34%、95.12%、97.56%、100.00%。对315份临床样本的检测结果显示，各方法之间的符合率均高于90.00%，其中iELISA、FPA、cELISA与mCFT符合率分别为97.14%、96.83%、92.70%；FPA、cELISA与iELISA符合率分别为95.24%、93.65%；FPA与cELISA符合率为91.43%。iELISA、FPA、mCFT 3种方法之间吻合性最高，cELISA与其他3种方法之间的吻合性略低。

Comparative Research of Four High Throughput Antibody Detection Methods for Brucella

To scientifically select and use brucellosis antibody detection method, and promote the standardization of brucellosis diagnostic reagents. In this study, the sensitivities of four methods, which included Brucella fluorescence polarisation assay (FPA) antibody test kit, animal brucellosis competitive ELISA (cELISA) antibody test kit, bovine brucellosis indirect ELISA (iELISA) antibody test kit and the improved micro complement fixation test (mCFT) developed by the National/OIE Reference Laboratory for Brucellosis, were determined with the brucellosis positive serum standard. The sensitivity and specificity of the four methods were assessed by the detection serum samples with known background. At the same time, the clinical bovine serum samples were detected by the above four methods, and the coincidence rates were compared. The results showed that the sensitivities of the four methods were the same. The detection results of brucellosis positive serum standard diluted 1∶20 (50 IU·mL^-1) was positive, and the detection results of brucellosis positive serum standard diluted 1∶40 (25 IU·mL^-1) was negative. The sensitivity of FPA, cELISA, iELISA and mCFT were 97.14%, 100.00%, 100.00%, 98.57%, respectively. The specificity of the four methods were 96.34%, 95.12%, 97.56%, 100.00%, respectively. By detecting the 315 clinical samples, the result showed that the coincidence rates of different methods were higher than 90.00%. According to the confirm result of mCFT, the coincidence rates of iELISA, FPA and cELISA were 97.14%, 96.83% and 92.70%, respectively. Compared with iELISA, the coincidence rates of FPA and cELISA were 95.24% and 93.65%, respectively. Compared with cELISA, the coincidence rate of FPA was 91.43%. The identical degree of iELISA, FPA and mCFT was the highest, while the identical degree of cELISA and the other three methods was slightly lower.