Department of Clinical Microbiology, Hospital Universitario 12 de Octubre, Avenida de Córdoba, s/n, 28041, Madrid, Spain.
Malaria & Emerging Parasitic Diseases Laboratory, Parasitology Department, National Microbiology Centre, Instituto de Salud Carlos III, Madrid, Spain.
Malar J. 2018 Aug 29;17(1):314. doi: 10.1186/s12936-018-2459-2.
Malaria is currently the most important human parasitic disease in the world responsible for high morbidity and mortality. Appropriate diagnostic methods are essential for early detection. Microscopy examination remains the gold standard, although molecular techniques have higher sensitivity and are very useful in cases of low parasitaemia and mixed infections. The objective of this study was to evaluate a new commercial molecular diagnostic technique.
A prospective, observational, multicentre study was performed between January 2015 and April 2017. All participants were immigrants from malaria-endemic areas, who were divided into two groups: asymptomatic group and symptomatic. Samples from both groups were evaluated by a rapid diagnostic test (ImmunoQuick Malaria + 4 RDT), microscopy examination, and two commercial molecular malaria tests (FTD Malaria and FTD Malaria Differentiation), then compared against an in-house reference PCR technique.
In all, 250 patients were included: 164 (65.6%) in the asymptomatic group, and 86 (34.4%) in the symptomatic group. There were seven cases of asymptomatic parasitaemia (prevalence = 2.8%) that were detected only by molecular methods. In the symptomatic group, there were seven cases of submicroscopic malaria. The main species detected was Plasmodium falciparum (96.6%). The commercial molecular technique had higher sensitivity than the other methods (S = 96%) and a high rate of concordance with the in-house reference PCR technique (Kappa score = 0.93).
The molecular techniques, although slower than microscopy, have adequate diagnostic accuracy and are very useful for the detection of P. falciparum in cases with low parasitaemia.
疟疾是目前世界上最重要的人类寄生虫病，导致高发病率和死亡率。适当的诊断方法对于早期发现至关重要。显微镜检查仍然是金标准，尽管分子技术具有更高的灵敏度，并且在低寄生虫血症和混合感染的情况下非常有用。本研究的目的是评估一种新的商业分子诊断技术。
进行了一项前瞻性、观察性、多中心研究，时间为 2015 年 1 月至 2017 年 4 月。所有参与者均为来自疟疾流行地区的移民，分为无症状组和有症状组。两组样本均通过快速诊断检测（ImmunoQuick 疟疾+4 RDT）、显微镜检查和两种商业分子疟疾检测（FTD 疟疾和 FTD 疟疾分化）进行评估，然后与内部参考 PCR 技术进行比较。
共纳入 250 例患者：无症状组 164 例（65.6%），有症状组 86 例（34.4%）。有 7 例无症状寄生虫血症（患病率=2.8%）仅通过分子方法检测到。在有症状组中，有 7 例亚微观疟疾。主要检测到的物种是恶性疟原虫（96.6%）。商业分子技术比其他方法具有更高的灵敏度（S=96%），并且与内部参考 PCR 技术的一致性很高（Kappa 评分=0.93）。
虽然比显微镜检查慢，但分子技术具有足够的诊断准确性，对于检测低寄生虫血症中的恶性疟原虫非常有用。
