Department of Microbiology and Hospital Hygiene, Tropical Microbiology and Entomology Unit, Bundeswehr Hospital Hamburg, Hamburg, Germany; Institute for Medical Microbiology, Virology and Hygiene, University Medicine Rostock, Rostock, Germany.
National Reference Centre for Tropical Pathogens, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.
Travel Med Infect Dis. 2019 Sep-Oct;31:101442. doi: 10.1016/j.tmaid.2019.06.013. Epub 2019 Jun 27.
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.
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.
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.
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.
本回顾性研究评估了两种商业 PCR 检测法，以确定其在区分人血中疟原虫种方面的可靠性。
将 817 例疑似或确诊疟疾患者的 1022 份血样提交至德国热带病国家参考中心，采用厚、薄血膜进行疟疾显微镜检查，并采用种属特异性疟疾实时 PCR 进行检测。对寄生虫阳性样本采用 RealStar 疟疾 S&T PCR 试剂盒 1.0（altona Diagnostics）和 FTD 疟疾鉴别（Fast Track Diagnostics）多重实时 PCR 检测法进行分析，这两种方法均针对种属特异性疟原虫 DNA。
1022 份血样中，247 份（24.2%）检测出疟原虫 spp.。两种多重检测法的性能特征非常相似，在疟疾显微镜检查阳性的 98.9%的样本中和在种属特异性 PCR 阳性的 95.1%（RealStar）和 96.8%（FTD）的样本中，提供了一致的种属信息。与 FTD 相比，RealStar 对亚微观、低水平的 P. falciparum 感染的敏感性略有降低，而 FTD 无法检测到 P. knowlesi。
评估的两种商业疟疾 PCR 检测法适用于区分临床样本中的疟原虫种，并且可以在显微镜检查结果不确定的情况下提供额外的信息。
