Evaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malaria.
Evaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malaria.
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DOI：
10.1186/1475-2875-8-241
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发表时间：
2009-10-27
期刊：
影响因子：
3
通讯作者：
Guerin PJ
中科院分区：
文献类型：
--
作者：
Ashley EA;Touabi M;Ahrer M;Hutagalung R;Htun K;Luchavez J;Dureza C;Proux S;Leimanis M;Lwin MM;Koscalova A;Comte E;Hamade P;Page AL;Nosten F;Guerin PJ
在非恶性疟疾普遍存在的地区，需要能够可靠区分疟疾种类的快速诊断测试。这些测试通常基于寄生虫乳酸脱氢酶（pLDH）的检测。在缅甸南部的Dawei，对临床疑似疟疾患者进行了三种基于pLDH的RDTs （CareStart™Malaria pLDH （Pan）、CareStart™Malaria pLDH （Pan, Pf）和OptiMAL-IT®）评估。每份RDT由两名阅读者独立阅读。显微镜下确诊的一部分疟疾患者在第2天和第7天重复rdt，然后每周重复一次，直到阴性。在研究结束时，研究批次的样品被送去进行热稳定性测试。2007年8月至11月期间，1004名年龄在1岁至93岁之间的患者参加了这项研究。玻片镜检（参考标准）诊断单间日疟原虫感染213例，单恶性疟原虫感染98例，650例无疟疾。检测疟疾的RDTs的灵敏度（sens）和特异性（spec）分别为：CareStart malaria™pLDH (Pan) test: sens 89.1% [CI95 84.2-92.6], spec 97.6% [CI95 96.5-98.4] OptiMal-IT®：Pf+/-其他物种检测：sens 95.2% [CI95 87.5-98.2], spec 94.7% [CI95 93.3-95.8]；非Pf单独检测：sens 89.6% [CI95 83.6-93.6], spec 96.5% [CI95 94.8-97.7] CareStart Malaria™pLDH (Pan, Pf): Pf+/-其他物种：sens 93.5% [CI9585.4-97.3], spec 97.4% [ci95.9 -98.3]；非pf: sens 78.5% [CI9571.1-84.4], spec 97.8% [CI95 96.3-98.7]，所有试验的观察者间一致性都很好（kappa > 0.9）。CareStart™疟疾检测中rdt变为阴性的中位时间为2天，OptiMAL-IT®为7天。除了OptiMAL-IT®（Pf特异性pLDH在35°C下稳定至第20天）外，测试的热稳定性可达90天。所有评估的基于pldh的RDTs都不能以高灵敏度检测非恶性疟疾，特别是在低寄生虫率的情况下。OptiMAL-IT®的总体表现最好，在疟疾高发地区的筛查发热病例中表现最好。然而，热稳定性是不可接受的，并且执行该测试的步骤数量是该领域的一个重大缺点。一种可靠的、热稳定的、高度敏感的、能够诊断所有疟原虫种类的RDT尚未确定。
In areas where non-falciparum malaria is common rapid diagnostic tests (RDTs) capable of distinguishing malaria species reliably are needed. Such tests are often based on the detection of parasite lactate dehydrogenase (pLDH). In Dawei, southern Myanmar, three pLDH based RDTs (CareStart™ Malaria pLDH (Pan), CareStart™ Malaria pLDH (Pan, Pf) and OptiMAL-IT®)were evaluated in patients presenting with clinically suspected malaria. Each RDT was read independently by two readers. A subset of patients with microscopically confirmed malaria had their RDTs repeated on days 2, 7 and then weekly until negative. At the end of the study, samples of study batches were sent for heat stability testing. Between August and November 2007, 1004 patients aged between 1 and 93 years were enrolled in the study. Slide microscopy (the reference standard) diagnosed 213 Plasmodium vivax (Pv) monoinfections, 98 Plasmodium falciparum (Pf) mono-infections and no malaria in 650 cases. The sensitivities (sens) and specificities (spec), of the RDTs for the detection of malaria were- CareStart Malaria™ pLDH (Pan) test: sens 89.1% [CI95 84.2-92.6], spec 97.6% [CI95 96.5-98.4] OptiMal-IT®: Pf+/- other species detection: sens 95.2% [CI95 87.5-98.2], spec 94.7% [CI95 93.3-95.8]; non-Pf detection alone: sens 89.6% [CI95 83.6-93.6], spec 96.5% [CI95 94.8-97.7] CareStart Malaria™ pLDH (Pan, Pf): Pf+/- other species: sens 93.5% [CI9585.4-97.3], spec 97.4% [95.9-98.3]; non-Pf: sens 78.5% [CI9571.1-84.4], spec 97.8% [CI95 96.3-98.7] Inter-observer agreement was excellent for all tests (kappa > 0.9). The median time for the RDTs to become negative was two days for the CareStart™ Malaria tests and seven days for OptiMAL-IT®. Tests were heat stable up to 90 days except for OptiMAL-IT® (Pf specific pLDH stable to day 20 at 35°C). None of the pLDH-based RDTs evaluated was able to detect non-falciparum malaria with high sensitivity, particularly at low parasitaemias. OptiMAL-IT® performed best overall and would perform best in an area of high malaria prevalence among screened fever cases. However, heat stability was unacceptable and the number of steps to perform this test is a significant drawback in the field. A reliable, heat-stable, highly sensitive RDT, capable of diagnosing all Plasmodium species has yet to be identified.
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DOI：
10.1016/j.trstmh.2007.09.014
发表时间：
2008-01-01
影响因子：
2.2
作者：
Fogg, Carole;Twesigye, Rogers;Guthmann, Jean-Paul
通讯作者：
Guthmann, Jean-Paul
DOI：
10.1016/s0035-9203(03)80100-1
发表时间：
2003-11-01
影响因子：
2.2
作者：
Pattanasin, S.;Proux, S.;Nosten, F.
通讯作者：
Nosten, F.
快速疟疾诊断测试对发烧患者治疗和健康结果的影响，桑给巴尔：一项跨界验证研究。
影响因子：
15.8
作者：
Msellem MI;Mårtensson A;Rotllant G;Bhattarai A;Strömberg J;Kahigwa E;Garcia M;Petzold M;Olumese P;Ali A;Björkman A
通讯作者：
Björkman A
影响因子：
--
作者：
Reyburn, Hugh;Mbakilwa, Hilda;Whitty, Christopher J. M.
通讯作者：
Whitty, Christopher J. M.
影响因子：
6.4
作者：
Baker, J;McCarthy, J;Cheng, Q
通讯作者：
Cheng, Q