Determinants of the accuracy of rapid diagnostic tests in malaria case management: evidence from low and moderate transmission settings in the East African highlands.
Determinants of the accuracy of rapid diagnostic tests in malaria case management: evidence from low and moderate transmission settings in the East African highlands.
复制标题
疟疾病例管理中快速诊断检测准确性的决定因素：来自东非高地低度和中度传播环境的证据。
DOI：
10.1186/1475-2875-7-202
复制
发表时间：
2008-10-03
期刊：
影响因子：
3
通讯作者：
Cox J
中科院分区：
文献类型：
--
作者：
Abeku TA;Kristan M;Jones C;Beard J;Mueller DH;Okia M;Rapuoda B;Greenwood B;Cox J
近年来，疟疾诊断的准确性重新受到关注，原因是治疗政策发生变化，倾向于采用成本相对较高的青蒿素类复方疗法。基于恶性疟原虫合成的富组氨酸蛋白2（HRP2）的快速诊断试验（RDTs）的使用已被广泛提倡，以节省成本，并最大限度地减少非疟疾发热性疾病的不适当治疗。基于HRP2的RDT是高度敏感和稳定的;然而，它们的特异性是引起关注的原因，特别是在由于先前感染的HRP2抗原持续存在而导致疟疾传播密集的地区。在这项研究中，78,454名临床诊断的疟疾患者在肯尼亚和乌干达的四个高原地区进行了为期约四年的基于HRP2的RDT检测，代表了低流行到中流行的环境。此外，在4个月内，在两个具有不同地方病水平的地点的2，241名受试者中，与专家显微镜进行疾病管理比较，评估了测试的效用。RDT阳性率因季节和年份而异，表明临床诊断准确性的时间变化。与专家显微镜检查相比，低流行地区RDT的敏感性、特异性、阳性预测值和阴性预测值分别为90.0%、99.9%、90.0%和99.9%。中度流行区相应指标分别为91.0%、65.0%、71.6%和88.1%。尽管两个研究中心的敏感性大致相当，但两个研究中心之间以及根据检测月份、患者年龄和咨询期间有无发热，特异性水平差异很大。特异性相对较高的年龄组和增加对年底的传输季节，表明抗HRP 2抗体所发挥的作用。寄生虫密度高的患者比寄生虫密度低的患者更有可能用RDTs检测阳性。RDT在低流行情况下使用可能有效，但在传播率中等高的地区可能会出现高误报率。应谨慎解释RDT特异性报告及其使用的成本效益分析，因为这些测量结果可能存在很大差异，具体取决于研究的患者的流行病学、季节和年龄组。
The accuracy of malaria diagnosis has received renewed interest in recent years due to changes in treatment policies in favour of relatively high-cost artemisinin-based combination therapies. The use of rapid diagnostic tests (RDTs) based on histidine-rich protein 2 (HRP2) synthesized by Plasmodium falciparum has been widely advocated to save costs and to minimize inappropriate treatment of non-malarial febrile illnesses. HRP2-based RDTs are highly sensitive and stable; however, their specificity is a cause for concern, particularly in areas of intense malaria transmission due to persistence of HRP2 antigens from previous infections. In this study, 78,454 clinically diagnosed malaria patients were tested using HRP2-based RDTs over a period of approximately four years in four highland sites in Kenya and Uganda representing hypoendemic to mesoendemic settings. In addition, the utility of the tests was evaluated in comparison with expert microscopy for disease management in 2,241 subjects in two sites with different endemicity levels over four months. RDT positivity rates varied by season and year, indicating temporal changes in accuracy of clinical diagnosis. Compared to expert microscopy, the sensitivity, specificity, positive predictive value and negative predictive value of the RDTs in a hypoendemic site were 90.0%, 99.9%, 90.0% and 99.9%, respectively. Corresponding measures at a mesoendemic site were 91.0%, 65.0%, 71.6% and 88.1%. Although sensitivities at the two sites were broadly comparable, levels of specificity varied considerably between the sites as well as according to month of test, age of patient, and presence or absence of fever during consultation. Specificity was relatively high in older age groups and increased towards the end of the transmission season, indicating the role played by anti-HRP2 antibodies. Patients with high parasite densities were more likely to test positive with RDTs than those with low density infections. RDTs may be effective when used in low endemicity situations, but high false positive error rates may occur in areas with moderately high transmission. Reports on specificity of RDTs and cost-effectiveness analyses on their use should be interpreted with caution as there may be wide variations in these measurements depending upon endemicity, season and the age group of patients studied.
登录
查看更多内容
DOI：
10.2471/blt.07.042259
发表时间：
2008-02-01
期刊：
Bulletin of the World Health Organization: International Journal of Public Health
影响因子：
--
作者：
Shillcutt, Samuel;Morel, Chantal;Mills, A
通讯作者：
Mills, A
影响因子：
6.4
作者：
Hopkins, Heidi;Bebell, Lisa;Dorsey, Grant
通讯作者：
Dorsey, Grant
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
影响因子：
9.6
作者：
Abeku, TA;Hay, SI;Ochola, S;Langi, P;Beard, B;de Vlas, SJ;Cox, J
通讯作者：
Cox, J