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目的评价一种新型恶性疟和间日疟联合快速检测胶体金试剂盒的检测性能。方法对2001年1月~2016年4月解放军第三〇二医院及协助医院留取的疟原虫感染患者及其他发热患者全血样本345例,分别采用疟原虫免疫胶体金法与显微镜检法进行疟原虫检测,以显微镜检法结果为金标准评价免疫胶体金快速检测试剂的灵敏度、特异度和一致性。结果发热患者中血涂片镜检法检出疟原虫感染204例,快速检测胶体金试剂盒检出疟原虫感染207例。其中恶性疟原虫免疫胶体金法检出111例,显微镜检法检出112例,灵敏度为99.11%,特异度为100.00%,两种方法一致性检验Kappa值为0.993,两种检测结果具有很好的一致性。间日疟原虫免疫胶体金法检测出96例,显微镜检法检出92例,灵敏度为100.00%,特异度为98.42%,两种方法的一致性检验Kappa值0.971,两种检测结果具有很好的一致性。结论新型快速检测试剂盒疟原虫抗体免疫胶体金法与显微镜检法结果具有较好的一致性,且具有操作简便、快速、无需专业仪器和专门技术人员等优点,适合于临床实验室疟疾的辅助诊断和筛查。
Objective To evaluate the detection performance of a new type of Plasmodium falciparum and Plasmodium vivax rapid detection kit. Methods A total of 345 whole blood samples of Plasmodium infection patients and other febrile patients collected from the 202nd Hospital and the Assisted Hospital of People’s Liberation Army from January 2001 to April 2016 were detected by immunogold assay and microscopy Plasmodium test, the microscopic examination results as the gold standard for evaluation of the sensitivity, specificity and consistency of immunogold gold rapid detection reagent. Results 204 cases of Plasmodium infection were detected by blood smear microscopy in the febrile patients, and 207 cases were detected by the rapid detection of colloidal gold kit. One hundred and eleven cases were detected by immunogold assay of Plasmodium falciparum, and 112 cases were detected by microscopy. The sensitivity was 99.11% and the specificity was 100.00%. The Kappa value of consistency test of two methods was 0.993, and the results of two tests were very good Consistency. 96 cases were detected by immunogold assay of Plasmodium vivax, 92 cases were detected by microscopy, the sensitivity was 100.00%, the specificity was 98.42%, the Kappa value of the two methods was 0.971, the results of the two methods were very good Consistency. Conclusion The new rapid test kit for Plasmodium antibody immuno-colloidal gold method and microscopy results have good consistency, and has the advantages of easy operation, rapid, without professional equipment and specialized technical personnel, suitable for clinical laboratory malaria aids Diagnosis and screening.