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一种系统性综述和荟萃分析,评估快速免疫层析试验在登革热诊断中的准确性。

A systematic review and meta-analysis on the accuracy of rapid immunochromatographic tests for dengue diagnosis.

机构信息

Programa de Pós-Graduação Em Gestão E Economia da Saúde, Universidade Federal de Pernambuco, Recife, PE, 50670-901, Brazil.

Programa de Pós-Graduação Em Inovação Terapêutica, Universidade Federal de Pernambuco, Recife, PE, 50670-901, Brazil.

出版信息

Eur J Clin Microbiol Infect Dis. 2022 Sep;41(9):1191-1201. doi: 10.1007/s10096-022-04485-6. Epub 2022 Aug 20.

Abstract

Rapid immunochromatographic tests are frequently used to diagnose dengue due to their easy use, low cost, and fast response. A high level of accuracy is essential for rapid diagnostic tests to support their large-scale use. Thus, this systematic review aims to evaluate the accuracy of rapid dengue diagnostic tests. The investigation was run through the following databases: LILACS, Medline (Pubmed), CRD, The Cochrane Library, Trip Medical Database, and Google Scholar. To solve difficulties, two independent reviewers performed document screening and selection. ELISA assay was adopted as a reference test because of several methodologic advantages. Seventeen articles were included accordingly, reckoning 6837 participating individuals. The receiver operating characteristic (ROC) and Forest Plot were conducted to evaluate the sensitivity and specificity for each analyzed parameter (anti-dengue IgM, IgG, and NS1 antigen). The risk of bias and quality of evidence were assessed as moderate using QUADAS-2 and Grading of Recommendations Assessment, Development, and Evaluation (GRADE), respectively. The sensitivity of IgM concerning the studied tests ranged from 13.8 to 90%, while that of NS1 ranged from 14.7 to 100% (95% CI). The antibodies with NS1 presented increased sensitivity; pooled data show that the association of the three analytes bestows the best result, with a combined sensitivity of 90% (CI 95%: 87-92%) and a pooled specificity of 89% (CI 95%: 87-92%). Thus, the present review provides relevant knowledge for decision-making between available rapid diagnostic tests.

摘要

快速免疫层析试验因其使用方便、成本低、反应迅速而常用于登革热的诊断。快速诊断试验的准确性对于支持其大规模使用至关重要。因此,本系统评价旨在评估快速登革热诊断试验的准确性。该研究通过以下数据库进行:LILACS、Medline(PubMed)、CRD、The Cochrane Library、Trip 医学数据库和 Google Scholar。为了解决困难,两名独立评审员进行了文件筛选和选择。由于具有多种方法学优势,采用 ELISA 检测作为参考检测。因此,相应地纳入了 17 篇文章,共涉及 6837 名参与者。进行了受试者工作特征(ROC)和森林图分析,以评估每个分析参数(抗登革热 IgM、IgG 和 NS1 抗原)的敏感性和特异性。使用 QUADAS-2 和推荐评估、制定和评估分级(GRADE)分别评估了偏倚风险和证据质量,均为中度。研究检测中 IgM 的敏感性范围为 13.8%至 90%,而 NS1 的敏感性范围为 14.7%至 100%(95%CI)。具有 NS1 的抗体具有更高的敏感性;汇总数据表明,三种分析物的联合具有最佳结果,合并敏感性为 90%(95%CI:87-92%),合并特异性为 89%(95%CI:87-92%)。因此,本综述为决策者在现有快速诊断试验之间提供了相关知识。

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