布鲁氏菌病补体结合酶联免疫吸附试验抗体检测试剂盒敏感性和特异性评价

Evaluation of the Sensibility and Specificity of the Complement Fixation Enzyme Linked Immunosorbent Assay Kit for Detecting Brucellosis Antibodies

为评价布鲁氏菌病补体结合酶联免疫吸附试验抗体检测试剂盒(CF-ELISA试剂盒)的敏感性、特异性及与其他试剂盒的符合率,用CF-ELISA试剂盒对布病感染地区牛、羊血清各200份,布病净化地区牛、羊群血清各100份进行抗体检测,同时与其他商品化检测试剂进行了比较。结果表明,感染地区牛、羊血清抗体的McNemar检验结果表明CF-ELISA试剂盒与间接酶联免疫吸附试验(iELISA)试剂盒和CGS的敏感性和特异性差异均不显著(P>0.05),Kappa一致性检验分析结果表明,CF-ELISA试剂盒与iELISA试剂盒检测结果有高度的符合性。检测净化地区牛、羊群血清抗体产品间的特异性和符合率均为100%。

To analysis the sensibility, specificity and coincidence rate of the complement fixation enzyme linked immunosorbent assay kit （ CF-ELISA kit ） for detecting brucellosis antibodies, 400 bovine and sheep serum specimens were collected from brucellosis-affected areas selecting CF-ELISA kit to detect brucellosis antibodies, where cases had already been identified. Another total of 200 bovine and sheep serum specimens for detecting antibodies were collected from no brucellosis-affected areas, where no cases had been identified. Results showed that there was no significant difference （P＆gt;0.05） among the CF-ELISA kit, iELISA kit and CGS for detecting antibodies of brucellosis-affected areas serum. Kappa statistics result showed that the method of CF-ELISA and iELISA had highly coincidence rate. The specificity and coincidence rate were 100% between the CF-ELISA kit and iELISA kit for detecting antibodies of no brucellosis-affected areas serum.