Faculty of Health, Medicine and Life Sciences (FHML), Maastricht, The Netherlands.
Malar J. 2009 Dec 12;8:293. doi: 10.1186/1475-2875-8-293.
Palutop+4 (All. Diag, Strasbourg, France), a four-band malaria rapid diagnostic test (malaria RDT) targeting the histidine-rich protein 2 (HRP-2), Plasmodium vivax-specific parasite lactate dehydrogenase (Pv-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) was evaluated in a non-endemic setting on stored whole blood samples from international travellers suspected of malaria.
Microscopy corrected by PCR was the reference method. Samples include those infected by Plasmodium falciparum (n = 323), Plasmodium vivax (n = 97), Plasmodium ovale (n = 73) and Plasmodium malariae (n = 25) and 95 malaria negative samples.
The sensitivities for the diagnosis of P. falciparum, P. vivax, P. malariae and P. ovale were 85.1%, 66.0%, 32.0% and 5.5%. Sensitivities increased at higher parasite densities and reached 90.0% for P. falciparum >100/microl and 83.8% for P. vivax > 500/microl. Fourteen P. falciparum samples reacted with the Pv-pLDH line, one P. vivax sample with the HRP-2 line, and respectively two and four P. ovale and P. malariae samples reacted with the HRP-2 line. Two negative samples gave a signal with the HRP-2 line. Faint and weak line intensities were observed for 129/289 (44.6%) HRP-2 lines in P. falciparum samples, for 50/64 (78.1%) Pv-pLDH lines in P. vivax samples and for 9/13 (69.2%) pan-pLDH lines in P. ovale and P. malariae samples combined. Inter-observer reliabilities for positive and negative readings were excellent for the HRP-2 and Pv-pLDH lines (overall agreement > 92.0% and kappa-values for each pair of readers >or= 0.88), and good for the pan-pLDH line (85.5% overall agreement and kappa-values >or= 0.74).
Palutop+4 performed moderately for the detection of P. falciparum and P. vivax, but sensitivities were lower than those of three-band malaria RDTs.
Palutop+4（All. Diag，斯特拉斯堡，法国）是一种针对组氨酸丰富蛋白 2（HRP-2）、间日疟原虫特异性虫体乳酸脱氢酶（Pv-pLDH）和泛疟原虫特异性 pLDH（pan-pLDH）的四带疟疾快速诊断检测（疟疾 RDT），在非流行地区对疑似疟疾的国际旅行者的储存全血样本进行了评估。
以 PCR 校正的显微镜检查为参考方法。样本包括感染恶性疟原虫（n = 323）、间日疟原虫（n = 97）、卵形疟原虫（n = 73）和三日疟原虫（n = 25）以及 95 例疟疾阴性样本。
诊断恶性疟原虫、间日疟原虫、三日疟原虫和卵形疟原虫的敏感性分别为 85.1%、66.0%、32.0%和 5.5%。敏感性随着寄生虫密度的增加而增加，恶性疟原虫 >100/µl 达到 90.0%，间日疟原虫 >500/µl 达到 83.8%。14 份恶性疟原虫样本与 Pv-pLDH 线反应，1 份间日疟原虫样本与 HRP-2 线反应，分别有 2 份和 4 份卵形疟原虫和三日疟原虫样本与 HRP-2 线反应。两份阴性样本与 HRP-2 线有信号。在恶性疟原虫样本中，289 个 HRP-2 线中的 129 个（44.6%）、间日疟原虫样本中 64 个 Pv-pLDH 线中的 50 个（78.1%）和卵形疟原虫和三日疟原虫样本中 13 个 pan-pLDH 线中的 9 个（69.2%）线的强度较弱。HRP-2 线和 Pv-pLDH 线的阳性和阴性读数的观察者间可靠性极好（总体一致性>92.0%，每对读者的kappa 值>0.88），pan-pLDH 线的可靠性良好（总体一致性为 85.5%，kappa 值>0.74）。
Palutop+4 对恶性疟原虫和间日疟原虫的检测效果中等，但敏感性低于三带疟疾 RDT。
