Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia.

Performance of three multi-species rapid diagnostic tests for diagnosis of Plasmodium falciparum and Plasmodium vivax malaria in Oromia Regional State, Ethiopia.
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DOI:
10.1186/1475-2875-9-297
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发表时间:
2010-10-27
期刊:
影响因子:
3
通讯作者:
Kolaczinski JH
Kolaczinski JH
中科院分区:
医学3区
文献类型:
--
作者:
Ashton RA;Kefyalew T;Tesfaye G;Counihan H;Yadeta D;Cundill B;Reithinger R;Kolaczinski JH

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埃塞俄比亚的疟疾传播是不稳定和可变的,由恶性疟原虫和间日疟原虫引起。联邦卫生部正在各级卫生系统扩大疟疾的寄生虫学诊断;在外围卫生设施,这将通过使用快速诊断测试来实现。本研究比较了三种RDT产品,为FMoH提供证据,以指导适当的产品选择。在奥罗米亚州Jimma区的三个健康中心,将三种多物种(pf-HRP 2/pan-pLDH和pf-HRP 2/醛缩酶)RDT(CareStart®、ParaScreen®和ICT Combo®)的性能与“金标准”显微镜进行了比较。在社区卫生站评估了卫生推广工作者使用RDT的便利性。RDT热稳定性根据WHO程序在受控实验室环境中进行测试。2009年5月至7月期间,共有2,383名疑似疟疾患者入组,其中23.2%经显微镜检查发现感染疟原虫。所有三种RDT在检测恶性疟原虫或混合感染方面的敏感性相同:85.6%(95%置信区间81.2-89.4)。RDT检测恶性疟原虫或混合感染的特异性相似,约为92%。对于检测间日疟原虫感染,所有三种RDT的灵敏度相似,范围为82.5%至85.0%。CareStart检测间日疟原虫的特异性(97.2%)高于ParaScreen和ICT Combo(分别为p < 0.001和p = 0.05)。卫生推广工作者更喜欢CareStart和ParaScreen而不是ICT Combo,因为卡匣上的条带标签清晰,而CareStart的“实验室包装”风格是首选设计。ParaScreen和CareStart通过了所有热稳定性测试,而ICT Combo的表现则不佳。考虑到定量性能、易用性和热稳定性的结合,CareStart似乎是埃塞俄比亚卫生站使用的最合适选择。当有新产品可用时,应定期重新评估埃塞俄比亚多物种RDT的选择,因为最好确定一种比此处评估的灵敏度更高的测试。
Malaria transmission in Ethiopia is unstable and variable, caused by both Plasmodium falciparum and Plasmodium vivax. The Federal Ministry of Health (FMoH) is scaling up parasitological diagnosis of malaria at all levels of the health system; at peripheral health facilities this will be through use of rapid diagnostic tests (RDTs). The present study compared three RDT products to provide the FMoH with evidence to guide appropriate product selection. Performance of three multi-species (pf-HRP2/pan-pLDH and pf-HRP2/aldolase) RDTs (CareStart®, ParaScreen® and ICT Combo®) was compared with 'gold standard' microscopy at three health centres in Jimma zone, Oromia Regional State. Ease of RDT use by health extension workers was assessed at community health posts. RDT heat stability was tested in a controlled laboratory setting according to WHO procedures. A total of 2,383 patients with suspected malaria were enrolled between May and July 2009, 23.2% of whom were found to be infected with Plasmodium parasites by microscopy. All three RDTs were equally sensitive in detecting P. falciparum or mixed infection: 85.6% (95% confidence interval 81.2-89.4). RDT specificity was similar for detection of P. falciparum or mixed infection at around 92%. For detecting P. vivax infection, all three RDTs had similar sensitivity in the range of 82.5 to 85.0%. CareStart had higher specificity in detecting P. vivax (97.2%) than both ParaScreen and ICT Combo (p < 0.001 and p = 0.05, respectively). Health extension workers preferred CareStart and ParaScreen to ICT Combo due to the clear labelling of bands on the cassette, while the 'lab in a pack' style of CareStart was the preferred design. ParaScreen and CareStart passed all heat stability testing, while ICT Combo did not perform as well. CareStart appeared to be the most appropriate option for use at health posts in Ethiopia, considering the combination of quantitative performance, ease of use and heat stability. When new products become available, the choice of multi-species RDT for Ethiopia should be regularly re-evaluated, as it would be desirable to identify a test with higher sensitivity than the ones evaluated here.
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