Playford E Geoffrey, Walker John
Centre for Infectious Diseases and Microbiology Laboratory Services, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead NSW 2145, Australia.
J Clin Microbiol. 2002 Nov;40(11):4166-71. doi: 10.1128/JCM.40.11.4166-4171.2002.
Rapid diagnostic tests (RDTs) are less reliant on expert microscopy and have the potential to reduce errors in malaria diagnosis but have not been extensively evaluated in nonimmune persons or in countries where infection is not endemic. We evaluated the ICT P.f/P.v (ICT-Amrad, Sydney, Australia) and OptiMal (Flow Inc., Portland, Oreg.) assays prospectively for the diagnosis of malaria in 158 specimens from 144 febrile returned travellers in Australia by using expert microscopy and PCR as reference standards. Malaria was diagnosed in 93 specimens from 87 patients by expert microscopy, with 3 additional specimens from recently treated patients testing positive for Plasmodium falciparum by PCR. For the diagnosis of asexual-stage P. falciparum malaria, the sensitivity and specificity of the ICT P.f/P.v assay were 97 and 90%, respectively, and those of the OptiMal assay were 85 and 96%, respectively. The ICT P.f/P.v assay missed one infection with a density of 45 parasites/ micro l, whereas the OptiMal assay missed infections up to 2,500/ micro l; below 1,000/ micro l, its sensitivity was only 43%. For the diagnosis of P. vivax malaria, the sensitivity and specificity of the ICT P.f/P.v assay were 44 and 100%, respectively, and those of the OptiMal assay were 80 and 97%, respectively. Both assays missed infections with parasite densities over 5,000/ micro l: up to 10,000/ micro l with the former and 5,300/ micro l with the latter. Despite the high sensitivity of the ICT P.f/P.v assay for P. falciparum malaria, caution is warranted before RDTs are widely adopted for the diagnosis of malaria in nonimmune patients or in countries where malaria is not endemic.
快速诊断检测（RDTs）对专业显微镜检查的依赖较小，有潜力减少疟疾诊断中的错误，但尚未在非免疫人群或疟疾非流行国家进行广泛评估。我们以前瞻性方式，通过使用专业显微镜检查和PCR作为参考标准，对144名发热回国旅行者的158份标本，评估了ICT P.f/P.v（ICT - Amrad，悉尼，澳大利亚）和OptiMal（Flow Inc.，波特兰，俄勒冈州）检测法用于疟疾诊断的情况。通过专业显微镜检查，在87名患者的93份标本中诊断出疟疾，另外有3份来自近期接受治疗患者的标本经PCR检测恶性疟原虫呈阳性。对于无性阶段恶性疟原虫疟疾的诊断，ICT P.f/P.v检测法的敏感性和特异性分别为97%和90%，OptiMal检测法的敏感性和特异性分别为85%和96%。ICT P.f/P.v检测法漏检了1例密度为45个寄生虫/微升的感染，而OptiMal检测法漏检了密度高达2500个/微升的感染；在1000个/微升以下，其敏感性仅为43%。对于间日疟原虫疟疾的诊断，ICT P.f/P.v检测法的敏感性和特异性分别为44%和100%，OptiMal检测法的敏感性和特异性分别为80%和97%。两种检测法都漏检了寄生虫密度超过5000个/微升的感染：前者高达10000个/微升，后者为5300个/微升。尽管ICT P.f/P.v检测法对恶性疟原虫疟疾具有高敏感性，但在非免疫患者或疟疾非流行国家广泛采用RDTs进行疟疾诊断之前，仍需谨慎。
