Clinical evaluation of a loop-mediated amplification kit for diagnosis of imported malaria.

Clinical evaluation of a loop-mediated amplification kit for diagnosis of imported malaria.
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DOI:
10.1093/infdis/jit183
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发表时间:
2013-08-15
期刊:
The Journal of infectious diseases
影响因子:
--
通讯作者:
Sutherland CJ
Sutherland CJ
中科院分区:
其他
文献类型:
--
作者:
Polley SD;González IJ;Mohamed D;Daly R;Bowers K;Watson J;Mewse E;Armstrong M;Gray C;Perkins MD;Bell D;Kanda H;Tomita N;Kubota Y;Mori Y;Chiodini PL;Sutherland CJ

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背景:疟疾的诊断依赖于通过显微镜或抗原检测的寄生虫检测;这两种方法都不能检测低密度感染。 新的检测方法可提供快速、敏感的诊断,而且培训需求最小,这将加强疟疾诊断和疟疾控制活动。我们确定了一种新的环介导扩增(LAMP)试剂盒在发热回国旅客中的诊断准确性。方法:从返回的旅行者中连续采集血样,送到专业的寄生虫学实验室进行病原体检测,对试剂盒进行评价。 进行显微镜检查,然后并行使用疟原虫属和恶性疟原虫特异性测试进行疟疾LAMP。对作为参比标准品的所有样品进行巢式聚合酶链反应(PCR)。与巢式PCR相比,LAMP诊断准确性的主要结果指标是灵敏度和特异性。结果:在初步分析中总共检测了705个样本。 LAMP恶性疟原虫引物的敏感性和特异性分别为98.4%和98.1%,疟原虫属引物的敏感性和特异性分别为97.0%和99.2%。对所有15项检测结果不一致的事后重复PCR分析解决了4个有利于LAMP的结果,表明初步分析低估了诊断准确性。结论:疟疾LAMP的诊断准确性与巢式PCR相似,但得到结果的时间大大缩短,且上级专业显微镜。 
Background. Diagnosis of malaria relies on parasite detection by microscopy or antigen detection; both fail to detect low-density infections. New tests providing rapid, sensitive diagnosis with minimal need for training would enhance both malaria diagnosis and malaria control activities. We determined the diagnostic accuracy of a new loop-mediated amplification (LAMP) kit in febrile returned travelers. Methods. The kit was evaluated in sequential blood samples from returned travelers sent for pathogen testing to a specialist parasitology laboratory. Microscopy was performed, and then malaria LAMP was performed using Plasmodium genus and Plasmodium falciparum–specific tests in parallel. Nested polymerase chain reaction (PCR) was performed on all samples as the reference standard. Primary outcome measures for diagnostic accuracy were sensitivity and specificity of LAMP results, compared with those of nested PCR. Results. A total of 705 samples were tested in the primary analysis. Sensitivity and specificity were 98.4% and 98.1%, respectively, for the LAMP P. falciparum primers and 97.0% and 99.2%, respectively, for the Plasmodium genus primers. Post hoc repeat PCR analysis of all 15 tests with discrepant results resolved 4 results in favor of LAMP, suggesting that the primary analysis had underestimated diagnostic accuracy. Conclusions. Malaria LAMP had a diagnostic accuracy similar to that of nested PCR, with a greatly reduced time to result, and was superior to expert microscopy.
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期刊: CLINICAL CHEMISTRY
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