Universitary Hospital of Burgos, Burgos, Spain.
National Microbiology Centre, Carlos III Health Institute, Madrid, Spain.
BMJ Open. 2021 Oct 29;11(10):e047825. doi: 10.1136/bmjopen-2020-047825.
The goal of this systematic scoping review is to collect and summarise scientific evidence regarding the validity of two simultaneous immunochromatographic tests for the conclusive diagnosis of Chagas disease. The research was informed by the following review questions: Will the use of two rapid tests be a valid method for the definitive diagnosis of Chagas disease when compared with conventional serological tests? In what type of population has the operation of two rapid tests been tried for the diagnosis of Chagas disease? What are the biomedical and public health advantages of the diagnostic method resulting from the combination of two rapid tests over the conventional serological method? Will it be a cost-benefit strategy for the diagnosis of Chagas with respect to conventional serological tests?
Systematic scoping review.
A search of the published and unpublished literature in five databases was carried out, in order to identify, screen and select the studies included in this review.
468 studies were identified, of which 46 were screened with a full-text reading, and finally, three articles were included in the review. All studies were in endemic countries with adult and paediatric populations (n=1133) and, together, they evaluated four different rapid tests. The rapid tests showed good sensitivity (97.4%-100%) and specificity (96.1%-100%) for the diagnosis of Chagas when used in combination and compared with the reference tests.
The simultaneous use of at least two immunochromatographic rapid tests is a valid option for the definitive diagnosis of chronic Chagas in endemic rural areas, as long as there are studies that previously evaluate their performance on the areas of implementation. Therefore, this could be an alternative to the current diagnostic standard. However, additional studies are still needed in more countries in order to provide further evidence and to investigate the cost-benefit.
本系统范围综述的目的是收集和总结有关两种同时免疫层析检测用于恰加斯病确证诊断的有效性的科学证据。研究依据以下综述问题：与传统血清学检测相比，使用两种快速检测是否将成为恰加斯病的一种有效确诊方法？在哪些人群中尝试了两种快速检测用于诊断恰加斯病？与传统血清学方法相比，两种快速检测联合的诊断方法在生物医学和公共卫生方面有何优势？与传统血清学检测相比，该方法在恰加斯病诊断方面是否具有成本效益？
系统范围综述。
在五个数据库中进行了已发表和未发表文献的搜索，以识别、筛选和选择纳入本综述的研究。
共确定了 468 项研究，其中 46 项进行了全文筛选，最终纳入了 3 篇文章。所有研究均在流行国家开展，纳入了成人和儿童人群（n=1133），并对四种不同的快速检测进行了评估。当联合使用并与参考检测相比时，快速检测对恰加斯病的诊断显示出良好的敏感性（97.4%-100%）和特异性（96.1%-100%）。
至少同时使用两种免疫层析快速检测是在流行地区的农村地区对慢性恰加斯病进行明确诊断的有效选择，只要有研究先前评估过它们在实施地区的性能。因此，这可能是当前诊断标准的替代方法。然而，还需要在更多国家进行更多研究，以提供进一步的证据并研究成本效益。
