Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo.
Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo.
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DOI：
10.1038/s41598-021-85913-z
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发表时间：
2021-03-22
影响因子：
4.6
通讯作者：
Kalonji A
中科院分区：
文献类型：
--
作者：
Parr JB;Kieto E;Phanzu F;Mansiangi P;Mwandagalirwa K;Mvuama N;Landela A;Atibu J;Efundu SU;Olenga JW;Thwai KL;Morgan CE;Denton M;Poffley A;Juliano JJ;Mungala P;Likwela JL;Sompwe EM;Rogier E;Tshefu AK;N'Siala A;Kalonji A
在非洲，大多数恶性疟原虫疟疾诊断是使用快速诊断测试（RDTs）来检测富含组氨酸的蛋白2。由于pfhrp 2和/或pfhrp 3基因（pfhrp 2/3）缺失的寄生虫引起的假阴性RDT结果的报道越来越多，引起了对现有疟疾诊断策略的关注。我们以前在刚果民主共和国（DRC）的无症状儿童中发现了pfhrp 2阴性寄生虫，但它们对诊断有症状疟疾的影响尚不清楚。我们在2017年对有症状的受试者进行了一项假阴性RDT的横断面研究。寄生虫的特点是显微镜; RDT; pfhrp 2/3基因分型和种属特异性PCR检测;疟原虫抗原的珠粒免疫测定;和/或全基因组测序。在3627例有症状的受试者中，427例（11.8%）的RDT-/显微镜检查结果为+。从8个（0.2%）样本的寄生虫最初被归类为推定的pfhrp 2/3缺失PCR，但抗原检测和全基因组测序证实存在完整的基因。56.8%的受试者患有PCR证实的疟疾。非恶性疟原虫合并恶性疟原虫感染常见（13.2%）。PCR和基于HRP 2的RDT之间的一致性是令人满意的（Cohen's kappa = 0.66），并且上级于显微镜检查（0.33）。没有观察到由pfhrp 2/3缺失的恶性疟原虫引起的症状性疟疾。正在进行的基于HRP 2的RDT使用适合于检测刚果民主共和国的恶性疟疾。
The majority of Plasmodium falciparum malaria diagnoses in Africa are made using rapid diagnostic tests (RDTs) that detect histidine-rich protein 2. Increasing reports of false-negative RDT results due to parasites with deletions of the pfhrp2 and/or pfhrp3 genes (pfhrp2/3) raise concern about existing malaria diagnostic strategies. We previously identified pfhrp2-negative parasites among asymptomatic children in the Democratic Republic of the Congo (DRC), but their impact on diagnosis of symptomatic malaria is unknown. We performed a cross-sectional study of false-negative RDTs in symptomatic subjects in 2017. Parasites were characterized by microscopy; RDT; pfhrp2/3 genotyping and species-specific PCR assays; a bead-based immunoassay for Plasmodium antigens; and/or whole-genome sequencing. Among 3627 symptomatic subjects, 427 (11.8%) had RDT-/microscopy + results. Parasites from eight (0.2%) samples were initially classified as putative pfhrp2/3 deletions by PCR, but antigen testing and whole-genome sequencing confirmed the presence of intact genes. 56.8% of subjects had PCR-confirmed malaria. Non-falciparum co-infection with P. falciparum was common (13.2%). Agreement between PCR and HRP2-based RDTs was satisfactory (Cohen’s kappa = 0.66) and superior to microscopy (0.33). Symptomatic malaria due to pfhrp2/3-deleted P. falciparum was not observed. Ongoing HRP2-based RDT use is appropriate for the detection of falciparum malaria in the DRC.
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