国产RDT用于疟疾病人实验室检查效果评价 李卫东1 张滔1 姜静静1 许.doc

国产RDT用于疟疾病人实验室检查效果评价【摘要】 目的 将国产RDT的检测结果与镜检、进口RDT以及PCR分别进行比较、评价，探讨国产RDT能否取代进口RDT。 方法 收集1例疟疾病人或疑似疟疾病人血样，采用两种RDT、镜检和PCR分别进行检测，将国产RDT检测结果分别与其他检测结果进行比较。结果 Evaluation the effect of domestic RDT for diagnostic of malaria Li Weidong, Zhang Tao, Jiang Jingjing, Xu Xian, Yu Chen, Zhao Lisheng, Xu Shudong, Ying Yaru, Wang Jianjun 【Abstract】Objective This study aims to compare the sensibility, specificity and consistency among microscopic examination, domestic RDT, imported RDT and PCR in the diagnosis of malaria, and provide the basis for decide that if domestic RDT can replace imported RDT or not. Methods 160 blood samples from malaria cases or suspected cases were collected, and detected by two kinds of RDT, microscopic examination, and PCR. Then, compare the result of domestic RDT with results of the other three methods. Results Total of 160 samples was tested; the positive rates of domestic RDT, imported RDT, microscopic examination and PCR were 45.00%, 47.50%, 41.25% and 42.50%, respectively. There was no statistically significant difference. 2 plasmodium ovale were detected by microscopic examination and PCR, but RDT. Compared to microscopic examination, the sensitivity of domestic RDT is 94%, the specificity is 87%, false positive rate 13%, false negative rate 6%, positive predictive value 83%, negative predictive value95%; Compared to PCR, the sensitivity of domestic RDT is 94%, the specificity is 89%, false positive rate 11%, false negative rate 6%, positive predictive value 83%, negative predictive value95%. Results of domestic and imported RDT statistic in consistency check, there was no statistically significant difference. Kappa value is 0.95. Concludes Domestic RDT can replace imported RDT to support active surveillance system. 【Key Words】Malaria; Domestic RDT; Microscopic Examination; Imported RDT; PCR; sensitivity; specificity 第一作者：李卫东 *通讯作者：王建军 作者单位：1 安徽省疾病预防控制中心 2 安徽医科大学流行病与卫生统计系 随着安徽省疟疾发病大幅度下降，疟疾防治工作进入清除阶段，传染源监测与发现十分重要[]。常用的疟疾诊断检测方法有镜检（血涂片显微镜检查）、