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Paracheck® 快速诊断检测试剂盒用于检测五岁以下儿童疟疾感染:布基纳法索的一项基于人群的调查。

Paracheck® rapid diagnostic test for detecting malaria infection in under five children: a population-based survey in Burkina Faso.

机构信息

Pôle Epidémiologie et Biostatistique, Institut de Recherche Expérimentale et Clinique (IREC), Faculté de Santé Publique (FSP), Université catholique de Louvain (UCL), Clos Chapelle-aux-champs 30, bte B1,30,13, 1200 Bruxelles, Belgium.

出版信息

Malar J. 2014 Mar 17;13:101. doi: 10.1186/1475-2875-13-101.

Abstract

BACKGROUND

Over the past ten years, Rapid Diagnostic Tests (RDT) played a major role in improving the use of biological malaria diagnosis, in particular in poor-resources settings. In Burkina Faso, a recent Demography and Health Survey (DHS) gave the opportunity to assess the performance of the Paracheck® test in under five children nationwide at community level.

METHODS

A national representative sample of 14,947 households was selected using a stratified two-stage cluster sampling. In one out of two households, all under five children were eligible to be tested for malaria using both RDT and microscopy diagnosis. Paracheck® performance was assessed using miscroscopy as the gold standard. Sensitivity and specificity were calculated as well as the diagnosis accuracy (DA) and the Youden index.

RESULTS

The malaria infection prevalence was estimated at 66% (95% CI: 64.8-67.2) according to microscopy and at 76.2% (95% CI: 75.1-77.3) according to Paracheck®. The sensitivity and specificity were estimated at 89.9% (95% CI: 89.0-90.8) and 50.4% (95% CI: 48.3-52.6) respectively with a Diagnosis Accuracy of 77% and a Youden index of 40%. The positive predictive value for malaria infection was 77.9% (95% CI: 76.7-79.1) and the negative predictive value was 72.1% (95% CI: 69.7-74.3). Variations were found by age group, period of the year and urban and rural areas, as well as across the 13 regions of the country.

CONCLUSION

While the sensitivity of the Paracheck® test was high, its specificity was poor in the general under five population of Burkina Faso. These results suggest that Paracheck® is not suitable to assess malaria infection prevalence at community level in areas with high malaria transmission. In such settings, malaria prevalence in the general population could be estimated using microscopy.

摘要

背景

在过去十年中,快速诊断检测(RDT)在改善生物疟疾诊断的应用方面发挥了重要作用,尤其是在资源匮乏的环境中。在布基纳法索,最近的人口与健康调查(DHS)提供了机会,在全国社区层面上评估 Paracheck® 检测在五岁以下儿童中的表现。

方法

使用分层两阶段聚类抽样方法选择了一个具有全国代表性的 14947 户家庭样本。在每两个家庭中,都有一个家庭的所有五岁以下儿童都有资格使用 RDT 和显微镜诊断进行疟疾检测。以显微镜检查为金标准评估 Paracheck® 的性能。计算了灵敏度和特异性,以及诊断准确性(DA)和 Youden 指数。

结果

根据显微镜检查,疟疾感染的流行率估计为 66%(95%CI:64.8-67.2),根据 Paracheck® 检查为 76.2%(95%CI:75.1-77.3)。灵敏度和特异性分别估计为 89.9%(95%CI:89.0-90.8)和 50.4%(95%CI:48.3-52.6),诊断准确性为 77%,Youden 指数为 40%。疟疾感染的阳性预测值为 77.9%(95%CI:76.7-79.1),阴性预测值为 72.1%(95%CI:69.7-74.3)。年龄组、一年中的时段以及城乡地区以及全国 13 个地区之间存在差异。

结论

虽然 Paracheck® 检测的灵敏度很高,但在布基纳法索五岁以下一般人群中的特异性很差。这些结果表明,在疟疾传播率高的地区,Paracheck® 不适合评估社区层面的疟疾感染流行率。在这种情况下,可以使用显微镜检查估计一般人群中的疟疾流行率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1cb9/3995324/c3817a9d47fd/1475-2875-13-101-1.jpg

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