Department of Parasitology-Mycology, Faculty of Medicine, Université des Sciences de la Santé, Libreville, Gabon.
Diagn Microbiol Infect Dis. 2013 Sep;77(1):58-63. doi: 10.1016/j.diagmicrobio.2013.05.007. Epub 2013 Jun 19.
The Malaria Pf Rapid Test Device Acon® (Acon Labs) and the pan HRP2/aldolase RDT, Malaria P.f/Pan Rapid Test Device Acon® (Acon Labs), performances were evaluated for malaria species diagnosis in 592 febrile patients living in Gabon using microscopy as gold standard. Sensitivities were equal or above 96.0% for Plasmodium falciparum detection, of 62.5% for non-P. falciparum malaria species detection and higher in younger children (100%). Negative predictive values were greater than 97.0%. Acon®HRP2 had a higher specificity (96.6%) and lower false-positive (FP) rate (9.3%) compared to Acon®Pf/Pan, which had a specificity of 87.3% and a FP rate of 27.1% (P < 0.01). Overall, 32.5% of all Acon® Pf/Pan tests resulted in a "faint band" with only 2 resulted from samples with a parasitemia below 100 p/μL. The accuracy of Acon®HRP2 RDT for the diagnosis of P. falciparum infection is confirmed. However, the high FP rate observed with Acon®Pf/Pan is a limitation for its use.
疟原虫 Pf 快速检测试剂盒 Acon®(Acon 实验室)和 pan HRP2/醛缩酶 RDT,疟疾 Pf/Pan 快速检测试剂盒 Acon®(Acon 实验室),在加蓬对 592 名发热患者进行了疟疾物种诊断的性能评估,以显微镜检查为金标准。用于检测恶性疟原虫的灵敏度等于或高于 96.0%,用于检测非恶性疟原虫的灵敏度为 62.5%,在年龄较小的儿童中更高(100%)。阴性预测值大于 97.0%。与 Acon®Pf/Pan 相比,Acon®HRP2 的特异性更高(96.6%),假阳性率(FP)更低(9.3%),Acon®Pf/Pan 的特异性为 87.3%,FP 率为 27.1%(P<0.01)。总体而言,所有 Acon®Pf/Pan 检测中有 32.5%的结果出现“微弱带”,仅 2 个结果来自寄生虫血症低于 100 p/μL 的样本。Acon®HRP2 RDT 对恶性疟原虫感染的诊断准确性得到了证实。然而,Acon®Pf/Pan 观察到的高 FP 率限制了其使用。