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在塞内加尔的Kédougou,三种基于LDH的疟疾快速诊断测试的性能和可用性评估

Babacar Souleymane Sambe¹, Stephanie Zobrist², William Sheahan³

¹Institut Pasteur de Dakar, Dakar, Senegal.

Parasites & vectors

|July 12, 2025

概括

疟疾快速诊断测试 (RDTs) 使用Plasmodium falciparum胺丰富蛋白2 (HRP2) 受到基因删除的威胁. 基于乳酸脱酶 (LDH) 的RDTs显示出潜力,但HRP2仍然对最佳测试性能做出了重大贡献.

科学领域:

疟疾学疟疾学
诊断测试开发诊断测试开发
寄生虫学的寄生虫学

背景情况:

寄生虫Plasmodium falciparum (Pf) 的出现,其中被删除的胺丰富蛋白2和3 (hrp2/hrp3) 基因损害了基于HRP2的疟疾快速诊断测试 (RDT) 的准确性.
针对Pf乳酸脱酶 (LDH) 的RDTs提供了减轻当前产品限制和加强疟疾病例管理的潜在替代方案.

研究的目的:

评估基于乳酸脱酶 (LDH) 的三种RDTs在塞内加尔Kédougou发烧患者的诊断性能和可用性.

主要方法:

进行了一项横截面诊断精度研究,涉及220名发烧患者.
使用基于HRP2的RDTs,三个基于LDH的RDTs (BIOCREDIT疟疾Ag Pf [pLDH],BIOCREDIT Pf [pLDH/HRPII],BIOCREDIT Pf/Pv [pLDH/pLDH]),显微镜和参考PCR试验测试了毛细血管和静脉血液样本.
对抗原度分析了RDT的性能,并通过问卷评估了可用性.

主要成果:

在220名参与者中,有154人 (70%) 通过PCR获得了Pf阳性. 生物信贷Pf (pLDH/HRPII) 测试显示了最高的灵敏度 (78%) 和特异性 (89%).
所有测试的RDTs都超过了显微镜 (53%的灵敏度). 与SD BIOLINE HRP2测试相比,BIOCREDIT Pf (pLDH/HRPII) 测试中的HRP2线提高了灵敏度,而单独的PfLDH线具有较低的灵敏度.
RDT性能与抗原度相关,检测的分析极限预测了观察到的灵敏度.

结论:

性能最好的Plasmodium falciparum RDT使用了HRP2和LDH的灵敏度.
在HRP2/HRP3缺失率较低的地区,单独使用PfLDH线不完全弥补HRP2线的性能,即使检测极限得到改善.
检测RDTs的分析极限可以有效地预测已知抗原度的人群中的测试性能.

关键词:

诊断诊断诊断诊断诊断胺丰富的蛋白质2 胺丰富的蛋白质2 乳酸脱酶的使用方法疟疾:疟疾是一种疾病.快速诊断测试是一种快速诊断测试.

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