巴拉圭农村地区恰加斯病血清学检测的质量保证。

IF 2.1 3区 医学 Q2 PARASITOLOGY Acta tropica Pub Date : 2024-09-05 DOI:10.1016/j.actatropica.2024.107382
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引用次数: 0

摘要

恰加斯病的诊断主要依赖于多种血清学检测,而在恰加斯病高发的许多偏远地区,这些检测往往无法使用。在巴拉圭中部的 Teniente Irala Fernández 市,人们一直在努力提高特定农村医疗中心的诊断能力,但却没有对结果进行质量保证。我们对伊拉拉-费尔南德斯卫生中心实验室(CSTIF)使用商用快速诊断检测(RDT)和酶联免疫吸附测定(ELISA)对 300 个样本进行检测后得出的结果,与在设备齐全的独立研究实验室(CEDIC)重复检测后得出的结果进行了比较分析。巴拉圭中央公共卫生实验室(LCSP)采用不同的技术对 52 份样本进行了进一步检测,以评估 CSTIF 所做检测的诊断性能。我们观察到,CSTIF 和 CEDIC 的 ELISA 检测结果非常吻合(每种检测试剂盒的卡帕系数在 0.85 和 0.93 之间),CSTIF 的检测结果总体良好。不过,在 CSTIF,一种试剂盒的灵敏度(81.3%)低于 CEDIC(100%)。在 CSTIF 单独使用 RDT 检测感染的灵敏度与结合 ELISA 检测获得的灵敏度相似(92.3% vs 88.5,p =1)。尽管如此,这一结果的普遍性仍然有限,需要进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Quality assurance of serologic testing for Chagas disease in a primary care setting of rural Paraguay

The diagnosis of Chagas disease mostly relies on the use of multiple serologic tests that are often unavailable in many of the remote settings where the disease is highly prevalent. In the Teniente Irala Fernández Municipality, in central Paraguay, efforts have been made to increase the diagnostic capabilities of specific rural health centres, but no quality assurance of the results produced has been performed. We comparatively analysed the results obtained with 300 samples tested using a commercial rapid diagnostic test (RDT) and enzyme linked immunosorbent assays (ELISA) at the laboratory of the Teniente Irala Fernández Health Center (CSTIF) with those generated upon repeating the tests at an independent well-equipped research laboratory (CEDIC). A subgroup of 52 samples were further tested at Paraguay's Central Public Health Laboratory (LCSP) by means of a different technique to evaluate the diagnostic performance of the tests carried out at CSTIF. We observed an excellent agreement between the ELISA results obtained at CSTIF and CEDIC (kappa coefficients between 0.85 and 0.93 for every kit evaluated), and an overall good performance of the tests carried out at CSTIF. However, the sensitivity of one kit was lower at CSTIF (81.3 %) than at CEDIC (100 %). The individual use of an RDT to detect the infection at CSTIF showed a similar sensitivity to that obtained combining it to an ELISA test (92.3% vs 88.5, p = 1). Nonetheless, the generalizability of this result is yet limited and will require of further studies.

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来源期刊
Acta tropica
Acta tropica 医学-寄生虫学
CiteScore
5.40
自引率
11.10%
发文量
383
审稿时长
37 days
期刊介绍: Acta Tropica, is an international journal on infectious diseases that covers public health sciences and biomedical research with particular emphasis on topics relevant to human and animal health in the tropics and the subtropics.
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