BACKGROUND The sensitivity of rapid diagnostic tests (RDTs) for malaria is inadequate for detecting low-density, often asymptomatic infections, such as those that can occur when screening pregnant women for malaria. The performance of the Alere™ Ultra-sensitive Malaria Ag Plasmodium falciparum RDT (uRDT) was assessed retrospectively in pregnant women in Indonesia. METHODS The diagnostic performance of the uRDT and the CareStart™ Malaria HRP2/pLDH VOM (Plasmodium vivax, Plasmodium ovale and Plasmodium malariae) Combo RDT (csRDT) were assessed using 270 stored red blood cell pellets and plasma samples from asymptomatic pregnant women. These included 112 P. falciparum negative and 158 P. falciparum positive samples detected by a composite test (qPCR, LAMP, nPCR) as reference standard. Diagnostic indicators: sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), diagnostic odds ratio (DOR) and the level of agreement (kappa) were calculated for comparison. RESULTS Compared with the reference test, the uRDT had a sensitivity of 19.6% (95% CI 13.9-26.8) and specificity of 98.2% (93.1-99.7%). The csRDT was 22.8% (16.7-30.3) sensitive and 95.5% (89.4-98.3) specific for P. falciparum infections. Performance of the uRDT was non-significantly different to the csRDT (p = 0.169). RDT outcome was stratified by qPCR cycling threshold (Ct), and performance of the RDTs was found to be comparable across parasite loads. CONCLUSION The uRDT performed similarly to the currently used csRDTs in detecting P. falciparum infections in asymptomatic pregnant women. In these settings, molecular diagnostics are currently the most sensitive for malaria.

中文翻译：

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使用高度敏感的快速诊断测试来筛查印度尼西亚怀孕期间的疟疾。

背景技术对疟疾的快速诊断测试（RDT）的敏感性不足以检测低密度，通常无症状的感染，例如在对孕妇进行疟疾筛查时可能发生的感染。回顾性评估了印度尼西亚孕妇的Alere™超敏感疟疾Ag恶性疟原虫RDT（uRDT）的性能。方法使用270例无症状孕妇的红细胞沉淀物和血浆样本评估了uRDT和CareStart™疟疾HRP2 / pLDH VOM（间日疟，卵形疟原虫和疟原虫）Combo RDT（csRDT）的诊断性能。这些包括112份恶性疟原虫阴性和158份恶性疟原虫阳性样品，这些样品通过复合检测（qPCR，LAMP，nPCR）作为参考标准进行检测。诊断指标：敏感性，特异性，计算阴性预测值（NPV），阳性预测值（PPV），诊断比值比（DOR）和一致性水平（kappa）进行比较。结果与参考测试相比，uRDT的敏感性为19.6％（95％CI 13.9-26.8），特异性为98.2％（93.1-99.7％）。对于恶性疟原虫感染，csRDT敏感性为22.8％（16.7-30.3），特异性为95.5％（89.4-98.3）。uRDT的性能与csRDT无显着差异（p = 0.169）。通过qPCR循环阈值（Ct）对RDT的结果进行分层，发现在寄生虫负荷下RDT的性能可比。结论在无症状孕妇中，uRDT的表现与目前使用的csRDT相似。在这些情况下，分子诊断方法目前对疟疾最为敏感。