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Use of Schistosoma mansoni soluble egg antigen (SEA) for antibody detection and diagnosis of schistosomiasis: The need for improved accuracy evaluations of diagnostic tools
Acta Tropica ( IF 2.1 ) Pub Date : 2020-12-23 , DOI: 10.1016/j.actatropica.2020.105800
Carlos Graeff-Teixeira , Vivian Favero , Renata Perotto de Souza , Vanessa Fey Pascoal , Hélio Radke Bittencourt , Mizuho Fukushige , Stefan Michael Geiger , Deborah Negrão-Corrêa

Many antigens for use in antibody-detection systems for schistosomiasis have been investigated over the past 40 years. In particular, soluble egg antigens (SEA) are still widely used in enzyme-linked immunosorbent assays (ELISAs) for detection of immunoglobulin classes and subclasses. Here, we conducted a literature review to examine accuracy evaluations of SEA-Immunoglobulin G (IgG)-ELISAs performed to detect Schistosoma mansoni infections and published between 1979 and 2019. S. mansoni is the main causative agent for intestinal schistosomiasis in many countries in Africa and Central and South America. After retrieving 214 relevant abstracts from the PubMed database, we selected 15 publications to undergo a full review. Sensitivity and specificity values varied from 71 to 99%, and from 6 to 100%, respectively. In addition, 11/15 studies did not state confidence intervals. Therefore, the findings from this review indicate that after four decades, we still do not have consistent evaluation estimates of SEA-IgG-ELISAs. Antigen mass per well and dilution of test sera in these articles varied from 0.018 µg to 1.5 µg, and from 1:50 to 1:500, respectively. Most of the reported accuracy evaluations used control sera which were selected based on parasitological examinations for egg detection, although ill-defined criteria were also noted. The number and composition of control serum panels was considered not adequate in approximately half of the studies. It is also noteworthy that among more than 30 diagnostic antigen preparations under development since the 1970s, most were not validated in the field and they failed to reach populations in need. Thus, attention to guidelines for standardization, estimations of accuracy, and reporting of results is needed to facilitate coordinated efforts aimed at schistosomiasis control and elimination.



中文翻译:

曼氏血吸虫可溶卵抗原(SEA)在血吸虫病抗体检测和诊断中的应用:需要改进诊断工具的准确性评估

在过去的40年中,已经研究了许多用于血吸虫病抗体检测系统的抗原。特别是,可溶性蛋抗原(SEA)仍广泛用于酶联免疫吸附测定(ELISAs)中,以检测免疫球蛋白的种类和亚类。在这里,我们进行了文献综述,以检查SEA-免疫球蛋白G(IgG)-ELISA的准确性,该检测用于检测曼氏血吸虫感染并于1979年至2019年发布是非洲和中南美洲许多国家肠道血吸虫病的主要病原体。从PubMed数据库检索了214个相关摘要之后,我们选择了15种出版物进行全面审查。灵敏度和特异性值分别从71%到99%和6%到100%不等。此外,11/15研究没有说明置信区间。因此,本次审查的结果表明,在四十年后,我们仍然没有一致的SEA-IgG-ELISA评估评估。这些制品中每孔的抗原质量和测试血清的稀释度分别为0.018 µg至1.5 µg,以及1:50至1:500。尽管也注意到了定义不明确的标准,但是大多数报告的准确性评估都使用了对照血清,该血清是根据寄生虫学检查选择的,用于检测鸡蛋。大约一半的研究认为对照血清板的数量和组成不充分。还值得注意的是,自1970年代以来正在开发的30多种诊断性抗原制剂中,大多数未经现场验证,因此无法满足需要的人群。因此,需要注意标准化指南,准确性评估和结果报告,以促进旨在控制和消除血吸虫病的协调努力。

更新日期:2020-12-29
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