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目的评价美国Inverness medical professional diagnostics公司生产的疟原虫检测试剂卡的临床应用效果。方法以镜检方法作为金标准比较BinaxNOW疟原虫检测试剂卡临床应用效果。结果 400份样本用镜检方法和BinaxNOW疟原虫检测试剂卡诊断,镜检法检出阳性138份,其中恶性疟77份、间日疟61份;疟原虫检测试剂卡检出阳性139例,其中恶性疟71份,间日疟68份。试剂卡检测疟疾的敏感度为98.55%,特异度为98.85%,检测恶性疟的灵敏度为87.01%、特异度为98.76%,检测间日疟的敏感度为93.44%、特异度为96.76%。存在交叉反应。结论BinaxNOW疟原虫检测试剂卡诊断疟疾敏感性与特异性高,操作简单,结果显示直观、快速,适合边远疟区无镜检能力的个体、乡村医生开展疟疾筛查。
Objective To evaluate the clinical application of Plasmodium test reagents produced by Inverness medical professional diagnostics in the United States. Methods The microscopic examination method was used as a gold standard to compare the clinical efficacy of BinaxNOW Plasmodium test reagent card. Results 400 samples were diagnosed by microscopic examination and BinaxNOW Plasmodium test kit, and 138 were positive by microscopy, of which 77 were Plasmodium falciparum and 61 were Plasmodium vivax. Plasmodium test kit was positive in 139 cases, Among them, 71 were Plasmodium falciparum and 68 were Plasmodium vivax. The sensitivity of the reagent card for detecting malaria was 98.55% and the specificity was 98.85%. The sensitivity and the specificity of detecting falciparum malaria were 87.01% and 98.76%. The sensitivity and specificity of the reagent card for detecting malaria were 93.44% and 96.76%. There is cross-reaction. Conclusion The BinaxNOW Plasmodium test kit has high sensitivity and specificity for diagnosis of malaria and simple operation. The results show that it is intuitive and rapid, suitable for individuals without microscopic features in remote malaria area, and rural doctors carry out malaria screening.