National Institute for Medical Research, Tanga Medical Research Centre, P.O. Box 5004, Tanga, Tanzania.
Malar J. 2011 Jun 26;10:176. doi: 10.1186/1475-2875-10-176.
Despite some problems related to accuracy and applicability of malaria rapid diagnostic tests (RDTs), they are currently the best option in areas with limited laboratory services for improving case management through parasitological diagnosis and reducing over-treatment. This study was conducted in areas with declining malaria burden to assess; 1) the accuracy of RDTs when used at different community settings, 2) the impact of using RDTs on anti-malarial dispensing by community-owned resource persons (CORPs) and 3) adherence of CORPs to treatment guidelines by providing treatment based on RDT results.
Data were obtained from: 1) a longitudinal study of passive case detection of fevers using CORPs in six villages in Korogwe; and 2) cross-sectional surveys (CSS) in six villages of Korogwe and Muheza districts, north-eastern, Tanzania. Performance of RDTs was compared with microscopy as a gold standard, and factors affecting their accuracy were explored using a multivariate logistic regression model.
Overall sensitivity and specificity of RDTs in the longitudinal study (of 23,793 febrile cases; 18,154 with microscopy and RDTs results) were 88.6% and 88.2%, respectively. In the CSS, the sensitivity was significantly lower (63.4%; χ2=367.7, p<0.001), while the specificity was significantly higher (94.3%; χ2=143.1, p<0.001) when compared to the longitudinal study. As determinants of sensitivity of RDTs in both studies, parasite density of<200 asexual parasites/μl was significantly associated with high risk of false negative RDTs (OR≥16.60, p<0.001), while the risk of false negative test was significantly lower among cases with fever (axillary temperature ≥37.5 °C) (OR≤0.63, p≤0.027). The risk of false positive RDT (as a determinant of specificity) was significantly higher in cases with fever compared to afebrile cases (OR≥2.40, p<0.001). Using RDTs reduced anti-malarials dispensing from 98.9% to 32.1% in cases aged ≥5 years.
Although RDTs had low sensitivity and specificity, which varied widely depending on fever and parasite density, using RDTs reduced over-treatment with anti-malarials significantly. Thus, with declining malaria prevalence, RDTs will potentially identify majority of febrile cases with parasites and lead to improved management of malaria and non-malaria fevers.
尽管疟疾快速诊断检测(RDT)在准确性和适用性方面存在一些问题,但在实验室服务有限的地区,它们仍是改善寄生虫病诊断病例管理和减少过度治疗的最佳选择。本研究在疟疾负担下降的地区进行,旨在评估:1)RDT 在不同社区环境下的准确性;2)社区拥有资源人员(CORP)使用 RDT 对抗疟药物配给的影响;3)CORP 根据 RDT 结果提供治疗的方式对治疗指南的遵守情况。
数据来自:1)在 Korogwe 的六个村庄中,通过 CORP 进行的被动病例检测的纵向研究;2)Korogwe 和 Muheza 区六个村庄的横断面调查(CSS),坦桑尼亚东北部。将 RDT 的性能与显微镜作为金标准进行比较,并使用多变量逻辑回归模型探讨影响其准确性的因素。
纵向研究(23793 例发热病例;18154 例有显微镜和 RDT 结果)中 RDT 的总体敏感性和特异性分别为 88.6%和 88.2%。在 CSS 中,与纵向研究相比,敏感性显著降低(63.4%;χ2=367.7,p<0.001),而特异性显著升高(94.3%;χ2=143.1,p<0.001)。在这两项研究中,作为 RDT 敏感性的决定因素,寄生虫密度<200 个无性体/μl 与假阴性 RDT 的高风险显著相关(OR≥16.60,p<0.001),而发热病例(腋窝温度≥37.5°C)(OR≤0.63,p≤0.027)中假阴性试验的风险显著降低。与无热病例相比,发热病例的 RDT 假阳性(作为特异性的决定因素)风险显著升高(OR≥2.40,p<0.001)。在年龄≥5 岁的病例中,使用 RDT 将抗疟药物的配给从 98.9%降低至 32.1%。
尽管 RDT 的敏感性和特异性较低,且差异很大,但取决于发热和寄生虫密度,使用 RDT 可显著减少对抗疟药物的过度治疗。因此,随着疟疾发病率的下降,RDT 将有可能识别出大多数有寄生虫的发热病例,并改善疟疾和非疟疾发热的管理。