Evaluation of the ICT malaria P.f/P.v and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers
Evaluation of the ICT malaria P.f/P.v and the OptiMal rapid diagnostic tests for malaria in febrile returned travellers
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DOI：
10.1128/jcm.40.11.4166-4171.2002
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发表时间：
2002-11-01
影响因子：
9.4
通讯作者：
Walker, J
中科院分区：
文献类型：
--
作者：
Playford, EG;Walker, J
快速诊断测试对专家显微镜的依赖程度较低，有可能减少疟疾诊断中的错误，但尚未在无免疫力的人或未流行感染的国家中进行广泛评估。我们评估了ICT的P /P。v （ICT-Amrad，澳大利亚悉尼）和OptiMal （Flow Inc.，俄勒冈州波特兰）采用专家显微镜和PCR作为参考标准，对来自澳大利亚144名发热回国旅行者的158份标本进行了前瞻性疟疾诊断分析。通过专家显微镜在87名患者的93份标本中诊断出疟疾，另外3份来自最近接受治疗的患者的标本经聚合酶链反应检测呈恶性疟原虫阳性。用于诊断无性期恶性疟疾P， ICT P.f/P的敏感性和特异性。v法的回收率分别为97%和90%，OptiMal法的回收率分别为85%和96%。ICT P.f/P。v方法漏检1例，漏检密度为45只/例，而最优方法最多可漏检2500只/例；在1000 / μ l以下，其灵敏度仅为43%。对于间日疟原虫疟疾的诊断，ICT P.f/P的敏感性和特异性比较。v法的回收率分别为44%和100%，OptiMal法的回收率分别为80%和97%。两种检测方法均未发现寄生虫密度超过5000 / μ l的感染病例：前者高达10000 / μ l，后者高达5300 / μ l。尽管ICT P.f/P的灵敏度很高。对于恶性疟原虫疟疾的检测，在非免疫患者或疟疾不流行的国家广泛采用RDTs诊断疟疾之前，有必要谨慎。
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/mul, whereas the OptiMal assay missed infections up to 2,500/mul; below 1,000/mul, 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/mul: up to 10,000/mul with the former and 5,300/mul 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.