Background

Two commercial PCR assays were assessed in a retrospective study to determine their reliability as tools for the differentiation of Plasmodium species in human blood.

Methods

A total of 1022 blood samples from 817 patients with suspected or confirmed malaria submitted to the German National Reference Centre for Tropical Pathogens were subjected to malaria microscopy using thick and thin blood films as well as to a genus-specific malaria real-time PCR. Parasite-positive samples were analysed by RealStar Malaria S&T PCR Kit 1.0 (altona Diagnostics) and FTD Malaria Differentiation (Fast Track Diagnostics) multiplex real-time PCR assays targeting species-specific Plasmodium DNA.

Results

Out of the 1022 blood samples, 247 (24.2%) tested positive for Plasmodium spp. The two multiplex assays showed rather similar performance characteristics and provided concordant species information in 98.9% of samples positive by malaria microscopy and in 95.1% (RealStar) and 96.8% (FTD) of samples positive by genus-specific PCR. Compared to FTD, RealStar revealed slightly reduced sensitivity for submicroscopic, low-level P. falciparum infections, while FTD was unable to detect P. knowlesi.

Conclusions

The two commercial malaria PCR assays assessed are suitable for discriminating Plasmodium species in clinical samples, and can provide additional information in cases of microscopically uncertain findings.

中文翻译：

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多重实时PCR分析的评估RealStar疟疾S＆T PCR试剂盒1.0和FTD疟疾分化法可用于临床样品中疟原虫物种的分化。

背景

在一项回顾性研究中评估了两种商业PCR检测方法，以确定它们作为区分人血中疟原虫种类的工具的可靠性。

方法

提交至德国国家热带病原体参考中心的817例疑似或确诊的疟疾患者的1022份血液样本经过厚，薄血膜以及属特异​​性疟疾实时PCR的疟疾显微镜检查。寄生虫阳性样品通过RealStar Malaria S＆T PCR Kit 1.0（altona Diagnostics）和FTD Malaria Differentiation（Fast Track Diagnostics）多重实时PCR测定法进行分析，这些测定法针对物种特异性疟原虫DNA。

结果

在1022份血液样本中，有247份（24.2％）的血浆疟原虫呈阳性。两种多重检测显示出相当相似的性能特征，并在疟疾显微镜检阳性的98.9％的样本中和属特异性PCR阳性的95.1％（RealStar）和96.8％（FTD）的样本中提供了一致的物种信息。与FTD相比，RealStar显示其对亚显微低水平恶性疟原虫感染的敏感性略有降低，而FTD无法检测到诺氏疟原虫。

结论

评估的两种商业性疟疾PCR检测方法适用于区分临床样品中的疟原虫种类，并且在显微镜不确定的发现情况下可以提供其他信息。