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目的评价自制的免疫胶体金诊断试剂盒对人间布鲁氏菌病(布病)的诊断价值。方法选取乌兰察布市地方病防治中心布病门诊的就诊者,确诊为布病患者做为病例组(34例),排除布病的非患者做为对照组(34例)。分别进行虎红平板凝集试验(RBPT)、试管凝集试验(SAT)、酶联免疫吸附试验(ELISA)以及自制免疫胶体金诊断试剂盒的检测,并对以上检测结果进行联合实验分析。结果自制免疫胶体金诊断试剂盒的检测结果与临床诊断结果差异无统计学意义(P>0.05)。该试剂盒的灵敏度为94.12%;漏诊率为5.88%;特异度为79.41%;误诊率为20.59%,正确指数为0.74;与临床诊断方法的符合率为86.76%,该试剂盒与虎红平板凝集试验串联使用,即两种试验结果均为阳性才诊断为布鲁氏菌阳性,灵敏度为94.12%,特异度为97.06%,正确指数为0.91,均高于其他几种方法的联合试验结果。结论自制免疫胶体金诊断试剂盒与虎红平板凝集试验的串联,方法简便、成本较低,对实验室仪器设备要求不高,容易操作,耗时较短,可应用于人间布病大面积的普查。
Objective To evaluate the diagnostic value of self-made immuno-colloidal gold diagnostic kit for human brucellosis (brucellosis). Methods Outpatients in the Clinics of Outpatient and Outpatient endeavors in Wulanchabu City were selected as the patients with brucellosis (34 cases) and non-patients with brucellosis as the control group (34 cases). RBPT, SAT, ELISA and self-made immuno-colloidal gold assay kit were used for the detection. The above-mentioned test results were combined with the experimental analysis. Results There was no significant difference between the results of self-made immunogold assay kit and clinical diagnosis (P> 0.05). The sensitivity of the kit was 94.12%, the rate of misdiagnosis was 5.88%, the specificity was 79.41%, the misdiagnosis rate was 20.59% and the correct index was 0.74. The coincidence rate with the clinical diagnostic method was 86.76% Agglutination test in series, that is, the two test results were positive diagnosed as Brucella positive, the sensitivity was 94.12%, the specificity was 97.06%, the correct index was 0.91, were higher than the combined test results of several other methods. Conclusion The self-made immune colloidal gold diagnostic kit is in tandem with tiger red plate agglutination test. The method is simple, low cost, less demanding on laboratory equipment, easy to operate and less time-consuming. It can be applied to a large area of human brucellosis Census.