Department of Medical Microbiology, Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands.
Malar J. 2010 Jun 18;9:171. doi: 10.1186/1475-2875-9-171.
Malaria Rapid Diagnostic Tests (RDTs) are widely used for diagnosing malaria. The present retrospective study evaluated the CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test targeting the Plasmodium falciparum specific antigen histidine-rich protein (HRP-2) and the pan-Plasmodium antigen lactate dehydrogenase (pLDH) in a reference setting.
The CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test was evaluated on a collection of samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included were P. falciparum (n = 320), Plasmodium vivax (n = 76), Plasmodium ovale (n = 76), Plasmodium malariae (n = 23) and Plasmodium negative samples (n = 95).
Overall sensitivity for the detection of P. falciparum was 88.8%, increasing to 94.3% and 99.3% at parasite densities above 100 and 1,000/microl respectively. For P. vivax, P. ovale and P. malariae, overall sensitivities were 77.6%, 18.4% and 30.4% respectively. For P. vivax sensitivity reached 90.2% for parasite densities above 500/microl. Incorrect species identification occurred in 11/495 samples (2.2%), including 8/320 (2.5%) P. falciparum samples which generated only the pan-pLDH line. For P. falciparum samples, 205/284 (72.2%) HRP-2 test lines had strong or medium line intensities, while for all species the pan-pLDH lines were less intense, especially in the case of P. ovale. Agreement between observers was excellent (kappa values > 0.81 for positive and negative readings) and test results were reproducible. The test was easy to perform with good clearing of the background.
The CareStart Malaria HRP-2/pLDH (Pf/pan) Combo Test performed well for the detection of P. falciparum and P. vivax, but sensitivities for P. ovale and P. malariae were poor.
疟疾快速诊断检测（RDT）被广泛用于诊断疟疾。本回顾性研究在参考环境下评估了针对恶性疟原虫特异性抗原组氨酸丰富蛋白（HRP-2）和泛疟原虫抗原乳酸脱氢酶（pLDH）的 CareStart 疟疾 HRP-2/pLDH（Pf/pan）组合检测。
使用聚合酶链反应校正的显微镜作为参考方法，对从返回的国际旅行者中采集的样本进行了 CareStart 疟疾 HRP-2/pLDH（Pf/pan）组合检测。包括恶性疟原虫（n=320）、间日疟原虫（n=76）、卵形疟原虫（n=76）、三日疟原虫（n=23）和疟原虫阴性样本（n=95）。
恶性疟原虫检测的总灵敏度为 88.8%，在寄生虫密度分别高于 100 和 1000/μl 时，灵敏度分别增加到 94.3%和 99.3%。间日疟原虫、卵形疟原虫和三日疟原虫的总灵敏度分别为 77.6%、18.4%和 30.4%。间日疟原虫的灵敏度在寄生虫密度高于 500/μl 时达到 90.2%。在 495 个样本中（2.2%）发生了 11 次错误的物种鉴定，包括仅产生泛 pLDH 线的 8/320（2.5%）恶性疟原虫样本。对于恶性疟原虫样本，284 个 HRP-2 测试线中的 205 个（72.2%）具有强或中强度线，而对于所有物种，泛 pLDH 线的强度较弱，尤其是卵形疟原虫。观察者之间的一致性极好（阳性和阴性读数的kappa 值>0.81），并且测试结果可重现。该测试易于执行，背景清除良好。
CareStart 疟疾 HRP-2/pLDH（Pf/pan）组合检测对恶性疟原虫和间日疟原虫的检测效果良好，但卵形疟原虫和三日疟原虫的敏感性较差。
