Clemente Benjie M, Pineda-Cortel Maria Ruth, Villaflores Oliver
Department of Medical Technology, Faculty of Pharmacy, University of Santo Tomas, España Boulevard, Sampaloc, Manila, Metro Manila, 1008, Philippines.
The Graduate School, University of Santo Tomas, España Boulevard, Sampaloc, Manila, Metro Manila, 1008, Philippines.
Heliyon. 2022 Nov 24;8(11):e11829. doi: 10.1016/j.heliyon.2022.e11829. eCollection 2022 Nov.
Leptospirosis, a common zoonotic infection in developing countries, usually progresses to severe conditions and poor outcomes when not detected early. Microscopic agglutination test (MAT) and culture are available but are not accessible in all areas and are usually confined to specialized laboratories. There are several available immunochromatographic test kits (ICT) that offer ease of use, access, and affordability, but diagnostic accuracy is not yet well established. In this paper, we aim to review published literature on the use of ICTs for the detection of leptospirosis and evaluate their diagnostic efficiency.
We systematically searched multiple databases (PubMed, Cochrane Library, and Google Scholar), including gray literature sources for published research articles as of April 13, 2022, on the diagnosis of acute leptospirosis using ICT. We assessed the methodological quality of each article using the revised QUADAS-2.
From a total of 41 articles, 30 (73.2%) were identified as potentially relevant after reviewing the title and abstract and eliminating duplicate articles; then, 22 (53.7%) articles were included after scrutinizing and applying the inclusion/exclusion criteria to the full text. Almost all test kits detect IgM antibodies against the except for one which used IgG as a marker for diagnosis of acute leptospirosis. A wide range of sensitivity (15.8%-100.0%) and specificity (37.3%-100.0%) were recorded. Lipopolysaccharide (LPS)-specific Immunochromatographic Lateral Flow Assay presented the highest sensitivity (∼93-100%) and specificity (∼99.19-100%).
Rapid diagnosis of acute leptospirosis is highly warranted; however, available test kits present a wide range of diagnostic accuracy. We found that LPS-specific ICT kit has the highest diagnostic efficiency; however, our analysis was limited by the included studies' heterogeneity in design and reporting; thus, we recommend standardization in the conduct and reporting of diagnostic accuracy of test kits as it is vital to evaluate the reliability of the test kit.
钩端螺旋体病是发展中国家常见的人畜共患感染病，若不及早发现，通常会发展为严重病症且预后不佳。显微镜凝集试验（MAT）和培养法虽可行，但并非在所有地区都能采用，且通常局限于专业实验室。市面上有几种免疫层析检测试剂盒（ICT），使用方便、易于获取且价格实惠，但诊断准确性尚未得到充分确立。在本文中，我们旨在回顾已发表的关于使用ICT检测钩端螺旋体病的文献，并评估其诊断效率。
我们系统检索了多个数据库（PubMed、Cochrane图书馆和谷歌学术），包括灰色文献来源，以查找截至2022年4月13日发表的关于使用ICT诊断急性钩端螺旋体病的研究文章。我们使用修订后的QUADAS-2评估每篇文章的方法学质量。
在总共41篇文章中，经标题和摘要审查并剔除重复文章后，确定30篇（73.2%）可能相关；然后，在对全文进行仔细审查并应用纳入/排除标准后，纳入22篇（53.7%）文章。几乎所有检测试剂盒都检测抗[此处原文缺失相关内容]的IgM抗体，只有一种试剂盒使用IgG作为急性钩端螺旋体病诊断的标志物。记录到的灵敏度范围很广（15.8%-100.0%），特异性范围也很广（37.3%-100.0%）。脂多糖（LPS）特异性免疫层析侧向流动分析的灵敏度最高（约93%-100%），特异性最高（约99.19%-100%）。
急性钩端螺旋体病的快速诊断非常必要；然而，现有的检测试剂盒诊断准确性差异很大。我们发现LPS特异性ICT试剂盒诊断效率最高；然而，我们的分析受到纳入研究在设计和报告方面异质性的限制；因此，我们建议在检测试剂盒诊断准确性的实施和报告方面进行标准化，因为这对于评估检测试剂盒的可靠性至关重要。
