Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia, AP 4314, Lima 100, Peru.
Malar J. 2010 Jun 7;9:154. doi: 10.1186/1475-2875-9-154.
The rapid diagnostic tests for malaria (RDT) constitute a fast and opportune alternative for non-complicated malaria diagnosis in areas where microscopy is not available. The objective of this study was to validate a RDT named Parascreen under field conditions in Iquitos, department of Loreto, Peru. Parascreen is a RDT that detects the histidine-rich protein 2 (HRP2) antigen from Plasmodium falciparum and lactate deshydrogenase from all Plasmodium species.
Parascreen was compared with microscopy performed by experts (EM) and polymerase chain reaction (PCR) using the following indicators: sensitivity (Se), specificity (Sp), positive (PV+) and negative predictive values (PV-), positive (LR+) and negative likehood ratio (LR-).
332 patients with suspected non-complicated malaria who attended to the MOH health centres were enrolled between October and December 2006. For P. falciparum malaria, Parascreen in comparison with EM, had Se: 53.5%, Sp: 98.7%, PV+: 66.7%, PV-: 97.8%, LR+: 42.27 and LR-: 0.47; and for non-P. falciparum malaria, Se: 77.1%, Sp: 97.6%, PV+: 91.4%, PV-: 92.7%, LR+: 32.0 and LR-: 0.22. The comparison of Parascreen with PCR showed, for P. falciparum malaria, Se: 81.8%, Sp: 99.1%, PV+: 75%, PV-: 99.4, LR+: 87.27 and LR-: 0.18; and for non-P. falciparum malaria Se: 76.1%, Sp: 99.2%, PV+: 97.1%, PV-: 92.0%, LR+: 92.51 and LR-: 0.24.
The study results indicate that Parascreen is not a valid and acceptable test for malaria diagnosis under the field conditions found in the Peruvian Amazon. The relative proportion of Plasmodium species, in addition to the genetic characteristics of the parasites in the area, must be considered before applying any RDT, especially after the finding of P. falciparum malaria parasites lacking pfhrp2 gene in this region.
快速诊断疟疾检测(RDT)是一种快速而适时的选择,可用于在没有显微镜的情况下诊断非复杂性疟疾。本研究的目的是在秘鲁洛雷托省伊基托斯地区对一种名为 Parascreen 的 RDT 进行现场验证。Parascreen 是一种检测恶性疟原虫 HRP2 抗原和所有疟原虫种乳酸脱氢酶的 RDT。
将 Parascreen 与专家显微镜(EM)和聚合酶链反应(PCR)进行比较,使用以下指标:敏感性(Se)、特异性(Sp)、阳性预测值(PV+)和阴性预测值(PV-)、阳性似然比(LR+)和阴性似然比(LR-)。
2006 年 10 月至 12 月期间,共有 332 名疑似非复杂性疟疾患者在卫生部医疗中心就诊。对于恶性疟原虫疟疾,与 EM 相比,Parascreen 的 Se 为 53.5%、Sp 为 98.7%、PV+为 66.7%、PV-为 97.8%、LR+为 42.27 和 LR-为 0.47;对于非恶性疟原虫疟疾,Se 为 77.1%、Sp 为 97.6%、PV+为 91.4%、PV-为 92.7%、LR+为 32.0 和 LR-为 0.22。与 PCR 相比,Parascreen 对恶性疟原虫疟疾的 Se 为 81.8%、Sp 为 99.1%、PV+为 75%、PV-为 99.4%、LR+为 87.27 和 LR-为 0.18;对于非恶性疟原虫疟疾,Se 为 76.1%、Sp 为 99.2%、PV+为 97.1%、PV-为 92.0%、LR+为 92.51 和 LR-为 0.24。
研究结果表明,Parascreen 在秘鲁亚马逊地区的现场条件下不是一种有效的、可接受的疟疾诊断检测方法。在应用任何 RDT 之前,除了该地区寄生虫的遗传特征外,还必须考虑到疟原虫种类的相对比例,特别是在该地区发现恶性疟原虫缺乏 pfhrp2 基因之后。