Das Smita, Jang Ihn Kyung, Barney Becky, Peck Roger, Rek John C, Arinaitwe Emmanuel, Adrama Harriet, Murphy Maxwell, Imwong Mallika, Ling Clare L, Proux Stephane, Haohankhunnatham Warat, Rist Melissa, Seilie Annette M, Hanron Amelia, Daza Glenda, Chang Ming, Nakamura Tomoka, Kalnoky Michael, Labarre Paul, Murphy Sean C, McCarthy James S, Nosten Francois, Greenhouse Bryan, Allauzen Sophie, Domingo Gonzalo J
Diagnostics Program, PATH, Seattle, Washington.
Infectious Disease Research Collaboration, Kampala, Uganda.
Am J Trop Med Hyg. 2017 Nov;97(5):1540-1550. doi: 10.4269/ajtmh.17-0245. Epub 2017 Aug 18.
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 -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.
灵敏的可现场部署诊断检测可助力疟疾防治项目实现消除疟疾目标。在乌干达纳贡埃拉和缅甸一个克伦族村庄（分别代表高传播地区和低传播地区）的无症状个体血液样本中，以及在四项诱导性血液期疟疾（IBSM）研究的参与者治疗前样本中，对新型Alere™疟疾抗原恶性疟原虫超灵敏快速诊断检测（uRDT）与目前可用的SD Bioline疟疾抗原恶性疟原虫快速诊断检测（RDT）的性能进行了比较。采用定量逆转录聚合酶链反应（qRT-PCR）和针对富含组氨酸蛋白II（HRP2）的高灵敏度酶联免疫吸附测定（ELISA）作为参考检测方法。与RDT相比，uRDT对HRP2的检测下限低10倍以上。在乌干达和缅甸，uRDT对qRT-PCR的灵敏度分别为84%和44%，而同一两个地点RDT的灵敏度分别为62%和0%。uRDT对乌干达和缅甸qRT-PCR的特异性分别为92%和99.8%，对HRP2参考ELISA的特异性分别为99%和99.8%。RDT对乌干达和缅甸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%。uRDT比RDT提前1.5天检测到IBSM研究参与者中的新感染。uRDT与目前可用的RDT具有相同的工作流程，但在识别无症状疟疾感染方面具有更好的性能特征。uRDT可能是疟疾消除策略的一个有用工具。
