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Abstract：
The early diagnosis of malaria is crucial to controlling morbidity and mortality. The World Health Organization (WHO) recommends diagnosing malaria either using light microscopy or a malaria rapid diagnostic test (RDT). Most RDTs use antibodies to detect two P. falciparum histidine-rich proteins named PfHRP2 and PfHRP3. However, false-negative results are known to occur due to the poor performance of RDTs depending on the species and the deletion of the Pfhrp2 and Pfhrp3 genes. This study evaluated new malaria RDTs for the detection of the human Plasmodium species. The Acro Malaria P.f./P.v./Pan Rapid Test Cassette allows the qualitative detection of parasite antigens, such as PfHRP2 specific to Plasmodium falciparum, PvLDH specific to Plasmodium vivax, and/or panLDH Plasmodium genus lactate dehydrogenase, in the blood of infected individuals. This RDT was assessed against 229 samples collected from imported malaria cases, mainly from Africa. The samples were previously diagnosed using light microscopy and RDT (SD Malaria Ag P.f./Pan, SD Bioline Alere Abbott), then confirmed using real time PCR. The two RDTs were evaluated using a comparison with real time PCR as the reference method, and their performances were compared with each other. Compared to SD RDT, the Acro RDT showed a better sensitivity to P. falciparum (96.8% vs. 89.8%), P. vivax (78.6% vs. 64.3%), P. ovale (73.7% vs. 5.3%), and P. malariae (20.0% vs. 0%). The respective specificities of the Acro RDT and SD RDT are 90.7% vs. 95.3% to P. falciparum, 100% to P. vivax, and 100% vs. 100% to Plasmodium genus. Therefore, Acro RDT showed better performance in the identification of P. ovale and low parasitaemia of P. falciparum. In addition, Acro RDT has the advantage of detecting PvLDH-specific antigens. The Acro Malaria RDT presents the benefits of detecting a P. falciparum antigen (PfHRP2) and a P. vivax antigen (PvLDH) with high sensitivity (96.8% and 73.7%, respectively) and specificity (90.7% and 100%, respectively). Acro Malaria P.f./P.v./Pan rapid diagnostic tests could be effectively used in endemic areas, especially when microscopic examination cannot be performed.
摘要：
疟疾的早期诊断对于控制发病率和死亡率至关重要。世界卫生组织（WHO）建议使用光学显微镜或疟疾快速诊断测试（RDT）诊断疟疾。大多数RDT使用抗体来检测两种名为PfHRP2和PfHRP3的恶性疟原虫富含组氨酸的蛋白质。然而,已知由于取决于物种的RDT的性能差以及Pfhrp2和Pfhrp3基因的缺失而发生假阴性结果。这项研究评估了用于检测人类疟原虫物种的新型疟疾RDT。AcroMalariaP.f./P.v./Pan快速检测盒允许定性检测寄生虫抗原，例如对恶性疟原虫具有特异性的PfHRP2，间日疟原虫特异性PvLDH，和/或panLDH疟原虫属乳酸脱氢酶，在感染者的血液中。对从输入的疟疾病例中收集的229个样本进行了RDT评估，主要来自非洲。先前使用光学显微镜和RDT（SD疟疾AgP.f./Pan，SDBiolineAlereAbbott)，然后使用实时PCR进行确认。使用实时PCR作为参考方法的比较来评估两个RDT，并对他们的表现进行了比较。与SDRDT相比，AcroRDT对恶性疟原虫表现出更好的敏感性(96.8%vs.89.8%），间日疟原虫（78.6%与64.3%），P.卵形（73.7%与5.3%），和疟原虫(20.0%与0%)。AcroRDT和SDRDT各自的特异性为90.7%与95.3%至恶性疟原虫，100%对间日疟原虫，和100%vs.100%为疟原虫属。因此,AcroRDT在鉴定卵形疟原虫和恶性疟原虫的低寄生虫血症方面表现出更好的性能。此外,AcroRDT具有检测PvLDH特异性抗原的优点。AcroMalariaRDT具有高灵敏度（96.8%和73.7%）检测恶性疟原虫抗原（PfHRP2）和间日疟原虫抗原（PvLDH）的优点，分别)和特异性(90.7%和100%，分别)。AcroMalariaP.f./P.v./Pan快速诊断测试可以有效地用于流行地区，特别是当显微镜检查不能进行。
