BinaxNOW 疟原虫检测试剂卡临床应用效果观察

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。

Results of clinical application of BinaxNOW Malaria Test Kit in diagnosis of plasmodium infection

Aim To evaluate the result of clinical application of BinaxNOW Malaria Test Kit produced by Inverness medical professional diagnostics in USA in detecting Plasmodium falciparum（P.falciparum）and Plasmodium vivax（P.vivax）. Methods Blood examination by microscopy was regarded as gold standard to evaluate the efficacy of BinaxNOW Malaria Test Kit in detection of malarial parasites. Results A total of 400 feverish cases were detected,138 cases were positive by microscopy examination including 77 P. falciparum positives and 61 P. vivax positives. There were 139 positives by BinaxNOW Malaria Test Kit including 71 P. falciparum positives and 68 P. vivax positives. The sensitivity and specificity of BinaxNOWR Malaria Test Kit were 98.55% and 98.85% respectively being 87.01% and 98.76% for detection of P. falciparum and 93.44%and 96.76% for detection of P. vivax. Crossreactions were also noticed. Conclusion The sensitivity and specificity of BinaxNOW R Malaria Test Kit is high,simple,reapid ,allowing direct obervation and thus it is suitable for application in detection of malaria parasites in remote areas.