背景:中国于2021年6月30日获得世界卫生组织的无疟疾认证。然而,由于输入的疟疾,在中国保持无疟疾状态是一个持续的挑战。在通过现有工具检测进口疟疾方面存在重大差距,尤其是非恶性疟疾。在研究中,在现场评估了一种用于检测输入型疟疾感染的新型即时快速诊断检测方法.
方法:纳入2018-2019年中国广西和安徽省报告的疑似输入性疟疾病例,以评估新型RDT。新型RDT的诊断性能是根据其灵敏度进行评估的,特异性,阳性和阴性预测值,和科恩的卡帕系数,使用聚合酶链反应作为黄金标准。计算加法和绝对净重新分类指数,以比较新型RDT和WondfoRDT(对照组)之间的诊断性能。
结果:使用新型RDT测试了总共602个样品。与PCR的结果相比,新型RDT呈现灵敏度,特异性,PPV,NPV,诊断准确率为78.37%,95.05%,94.70%,79.59%,和86.21%,分别。在阳性样本中,新的RDT发现了87.01%,71.31%,81.82%,恶性疟原虫的61.54%,P.Ovale,间日疟原虫,和疟原虫,分别。新型和WondfoRDT(对照组)检测非恶性疟疾的能力没有显着差异。然而,WondfoRDT可以检测到比新型RDT更多的恶性疟原虫病例(96.10%vs.87.01%,p<0.001)。在小说RDT的介绍之后,加性和绝对净重新分类指数的值分别为1.83%和1.33%,分别。
结论:新型RDT显示出能够区分卵卵圆虫和malariae与间日疟原虫的能力,这可能有助于改善中国消除疟疾后的监测工具。
BACKGROUND: China was certified malaria-free by the World Health Organization on 30 June 2021. However, due to imported malaria, maintaining a malaria-free status in
China is an ongoing challenge. There are critical gaps in the detection of imported malaria through the currently available tools, especially for non-falciparum malaria. In the study, a novel point-of-care Rapid Diagnostic Test designed for the detection of imported malaria infections was evaluated in the field.
METHODS: Suspected imported malaria cases reported from Guangxi and Anhui Provinces of
China during 2018-2019 were enrolled to evaluate the novel RDTs. Diagnostic performance of the novel RDTs was evaluated based on its sensitivity, specificity, positive and negative predictive values, and Cohen\'s kappa coefficient, using polymerase chain reaction as the gold standard. The Additive and absolute Net Reclassification Index were calculated to compare the diagnostic performance between the novel RDTs and Wondfo RDTs (control group).
RESULTS: A total of 602 samples were tested using the novel RDTs. Compared to the results of PCR, the novel RDTs presented sensitivity, specificity, PPV, NPV, and diagnostic accuracy rates of 78.37%, 95.05%, 94.70%, 79.59%, and 86.21%, respectively. Among the positive samples, the novel RDTs found 87.01%, 71.31%, 81.82%, and 61.54% of P. falciparum, P. ovale, P. vivax, and P. malariae, respectively. The ability to detect non-falciparum malaria did not differ significantly between the novel and Wondfo RDTs (control group). However, Wondfo RDTs can detect more P. falciparum cases than the novel RDTs (96.10% vs. 87.01%, p < 0.001). After the introduction of the novel RDTs, the value of the additive and absolute Net Reclassification Index is 1.83% and 1.33%, respectively.
CONCLUSIONS: The novel RDTs demonstrated the ability to distinguish P. ovale and P. malariae from P. vivax which may help to improve the malaria post-elimination surveillance tools in
China.