Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections.

Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections.
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DOI:
10.4269/ajtmh.17-0245
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发表时间:
2017-11
期刊:
The American journal of tropical medicine and hygiene
影响因子:
--
通讯作者:
Domingo GJ
Domingo GJ
中科院分区:
其他
文献类型:
--
作者:
Das S;Jang IK;Barney B;Peck R;Rek JC;Arinaitwe E;Adrama H;Murphy M;Imwong M;Ling CL;Proux S;Haohankhunnatham W;Rist M;Seilie AM;Hanron A;Daza G;Chang M;Nakamura T;Kalnoky M;Labarre P;Murphy SC;McCarthy JS;Nosten F;Greenhouse B;Allauzen S;Domingo GJ

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敏感的现场可部署诊断测试可帮助疟疾规划实现消除。将一种新的Alere™疟疾Ag P.f超灵敏快速诊断试剂盒(uRDT)与目前可用的SD Bioline疟疾Ag P.f RDT在乌干达Nagongera和缅甸Karen村(分别代表高传播区和低传播区)无症状个体的血液标本以及来自四项恶性疟原虫诱导的血期疟疾(IBSM)研究参与者的预处理标本中的表现进行了比较。采用定量反转录PCR (qRT-PCR)和高灵敏度酶联免疫吸附法(ELISA)检测富组氨酸蛋白II (HRP2)作为参比检测。与RDT相比,uRDT对HRP2的检测下限大于10倍。乌干达和缅甸的uRDT对qRT-PCR的敏感性分别为84%和44%,RDT对相同两个位点的敏感性分别为62%和0%。乌干达和缅甸的uRDT与qRT-PCR的特异性分别为92%和99.8%,与HRP2参考ELISA的特异性分别为99%和99.8%。RDT对乌干达和缅甸的qRT-PCR的特异性分别为95%和100%,对HRP2参考ELISA的特异性分别为96%和100%。在IBSM研究参与者中,uRDT检测新感染的时间比RDT早1.5天。uRDT具有与目前可用的rdt相同的工作流程,但改进了识别无症状疟疾感染的性能特征。uRDT可能是消除疟疾战略的有用工具。
Sensitive field-deployable diagnostic tests can assist malaria programs in achieving elimination. The performance of a new Alere™ Malaria Ag P.f Ultra Sensitive rapid diagnostic test (uRDT) was compared with the currently available SD Bioline Malaria Ag P.f RDT in blood specimens from asymptomatic individuals in Nagongera, Uganda, and in a Karen Village, Myanmar, representative of high- and low-transmission areas, respectively, as well as in pretreatment specimens from study participants from four Plasmodium falciparum-induced blood-stage malaria (IBSM) studies. A quantitative reverse transcription PCR (qRT-PCR) and a highly sensitive enzyme-linked immunosorbent assay (ELISA) test for histidine-rich protein II (HRP2) were used as reference assays. The uRDT showed a greater than 10-fold lower limit of detection for HRP2 compared with the RDT. The sensitivity of the uRDT was 84% and 44% against qRT-PCR in Uganda and Myanmar, respectively, and that of the RDT was 62% and 0% for the same two sites. The specificities of the uRDT were 92% and 99.8% against qRT-PCR for Uganda and Myanmar, respectively, and 99% and 99.8% against the HRP2 reference ELISA. The RDT had specificities of 95% and 100% against qRT-PCR for Uganda and Myanmar, respectively, and 96% and 100% against the HRP2 reference ELISA. The uRDT detected new infections in IBSM study participants 1.5 days sooner than the RDT. The uRDT has the same workflow as currently available RDTs, but improved performance characteristics to identify asymptomatic malaria infections. The uRDT may be a useful tool for malaria elimination strategies.
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