a Anti Malaria Campaign, Ministry of Health , Colombo , Sri Lanka.
b World Health Organization -Regional Office for South East Asia , New Delhi , India.
Pathog Glob Health. 2018 Oct;112(7):360-367. doi: 10.1080/20477724.2018.1536855. Epub 2018 Oct 24.
The utility of CareStart Malaria Pf/PAN (HRP2/pLDH) Ag Combo Test, in detecting non-endemic clinical malaria cases was evaluated in Sri Lanka, a country in prevention of re-establishment of malaria following elimination. RDT, microscopy and nested PCR were performed for 350 suspected malaria patients recruited prospectively. There were 173 PCR confirmed malaria patients and 177 PCR negative subjects. Plasmodium falciparum amounted to 48% of infections with 44% P. vivax, 6% P. ovale and 2% P. malariae. Performance characteristics of RDTs and microscopy were compared with nested PCR. Sensitivity and specificity of RDT with 95% confidence intervals (CI) were as follows: any malaria infection 95.95% (CI = 91.84-98.36) and 94.92% (CI = 90.57-97.65); P. falciparum 100% (CI = 95.65-100) and 97.00% (CI = 94.18-98.70) and other species 92.22% (CI = 84.63-96.82) and 99.62% (97.88-99.99) respectively. A significant difference between sensitivities of HRP2 (100%, CI = 95.65-100) and pan pLDH line (68.67%, CI = 57.56-78.41) was seen for P. falciparum, parasite densities less than 1000 parasites/microliter being detected only by HRP2. Sensitivity and specificity of microscopy with 95% CI were as follows: any malaria infection, 94.22% (CI = 89.63-97.19) and 99.44% (CI = 96.89-99.99); P. falciparum 89.16% (CI = 80.40-94.90) and 99.63% (CI = 97.94-99.99); other species 98.89% (CI = 93.96-99.97) and 100% (CI = 98.59-100) respectively. The low sensitivity of pan specific pLDH for P. falciparum, P. ovale and P. malariae should be taken in to consideration when using this RDT as a point of care test when and wherever microscopy facilities are not readily available. Considering the low sensitivity of microscopy for P. falciparum, it is preferable to perform both tests, when malaria is highly suspected.
在斯里兰卡，人们评估了 CareStart 疟疾 Pf/PAN（HRP2/pLDH）Ag Combo 检测试剂盒用于检测非地方性临床疟疾病例的效用。对 350 名前瞻性招募的疑似疟疾患者进行了 RDT、显微镜检查和巢式 PCR 检测。有 173 例 PCR 确诊的疟疾患者和 177 例 PCR 阴性患者。疟原虫感染中恶性疟原虫占 48%，间日疟原虫占 44%，卵形疟原虫占 6%，三日疟原虫占 2%。将 RDT 和显微镜检查的性能特征与巢式 PCR 进行了比较。RDT 的灵敏度和特异性（95%置信区间）如下：任何疟疾感染 95.95%（91.84-98.36）和 94.92%（90.57-97.65）；恶性疟原虫 100%（95.65-100）和 97.00%（94.18-98.70）；其他物种 92.22%（84.63-96.82）和 99.62%（97.88-99.99）。HRP2（100%，95.65-100）和 pan pLDH 线（68.67%，57.56-78.41）对恶性疟原虫的敏感性存在显著差异，检测到的寄生虫密度小于 1000 个/微升仅 HRP2 可检测到。显微镜检查的灵敏度和特异性（95%CI）如下：任何疟疾感染，94.22%（89.63-97.19）和 99.44%（96.89-99.99）；恶性疟原虫 89.16%（80.40-94.90）和 99.63%（97.94-99.99）；其他物种 98.89%（93.96-99.97）和 100%（98.59-100）。当显微镜检查设施无法随时获得时，应考虑到 pan 特异性 pLDH 对恶性疟原虫、卵形疟原虫和三日疟原虫的敏感性较低，在使用这种 RDT 作为即时护理检测时应予以考虑。鉴于显微镜检查对恶性疟原虫的敏感性较低，在高度怀疑疟疾时，最好同时进行这两种检查。
