Department of Clinical Medicine, Institute of Tropical Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium.
Malar J. 2009 Nov 22;8:262. doi: 10.1186/1475-2875-8-262.
The SD FK80 P.f/P.v Malaria Antigen Rapid Test (Standard Diagnostics, Korea) (FK80) is a three-band malaria rapid diagnostic test detecting Plasmodium falciparum histidine-rich protein-2 (HRP-2) and Plasmodium vivax-specific lactate dehydrogenase (Pv-pLDH). The present study assessed its performance in a non-endemic setting.
Stored blood samples (n = 416) from international travellers suspected of malaria were used, with microscopy corrected by PCR as the reference method. Samples infected by Plasmodium falciparum (n = 178), Plasmodium vivax (n = 99), Plasmodium ovale (n = 75) and Plasmodium malariae (n = 24) were included, as well as 40 malaria negative samples.
Overall sensitivities for the diagnosis of P. falciparum and P. vivax were 91.6% (95% confidence interval (CI): 86.2% - 95.0%) and 75.8% (65.9% - 83.6%). For P. falciparum, sensitivity at parasite densities >or= 100/microl was 94.6% (88.8% - 97.6%); for P. vivax, sensitivity at parasite densities >or= 500/microl was 86.8% (75.4% - 93.4%). Four P. falciparum samples showed a Pv-pLDH line, three of them had parasite densities exceeding 50.000/microl. Two P. vivax samples, one P. ovale and one P. malariae sample showed a HRP-2 line. For the HRP-2 and Pv-pLDH lines, respectively 81.4% (136/167) and 55.8% (43/77) of the true positive results were read as medium or strong line intensities. The FK80 showed good reproducibility and reliability for test results and line intensities (kappa values for both exceeding 0.80).
The FK80 test performed satisfactorily in diagnosing P. falciparum and P. vivax infections in a non-endemic setting.
SD FK80 P.f/P.v 疟原虫抗原快速检测试剂盒（韩国标准诊断公司）（FK80）是一种三带疟原虫快速诊断检测试剂盒，可检测恶性疟原虫（Plasmodium falciparum）组氨酸丰富蛋白-2（HRP-2）和间日疟原虫（Plasmodium vivax）特异性乳酸脱氢酶（Pv-pLDH）。本研究在非流行地区评估了其性能。
使用了来自疑似疟疾的国际旅行者的储存血样（n = 416），以聚合酶链反应校正的显微镜检查作为参考方法。样本中包括感染恶性疟原虫（n = 178）、间日疟原虫（n = 99）、卵形疟原虫（n = 75）和三日疟原虫（n = 24），以及 40 个疟疾病例阴性样本。
诊断恶性疟原虫和间日疟原虫的总体敏感性分别为 91.6%（95%置信区间：86.2% - 95.0%）和 75.8%（65.9% - 83.6%）。对于寄生虫密度≥100/µl 的恶性疟原虫，敏感性为 94.6%（88.8% - 97.6%）；对于寄生虫密度≥500/µl 的间日疟原虫，敏感性为 86.8%（75.4% - 93.4%）。4 份恶性疟原虫样本出现 Pv-pLDH 线，其中 3 份寄生虫密度超过 50.000/µl。2 份间日疟原虫样本、1 份卵形疟原虫和 1 份三日疟原虫样本出现 HRP-2 线。对于 HRP-2 和 Pv-pLDH 线，分别有 81.4%（136/167）和 55.8%（43/77）的真阳性结果被读为中或强线强度。FK80 对检测结果和线强度具有良好的重现性和可靠性（kappa 值均超过 0.80）。
FK80 试验在非流行地区诊断恶性疟原虫和间日疟原虫感染时表现良好。
