PDF(Pubmed)
Abstract：
BACKGROUND: In the last two decades, several rapid lateral flow immunoassays (LFIs) for the diagnosis of human leptospirosis were developed and commercialized. However, the accuracy and reliability of these LFIs are not well understood. In this study, we aimed to evaluate the accuracy of leptospirosis LFIs as well as the factors affecting the test efficiency using systematic review and meta-analysis.
RESULTS: Original articles reporting the accuracy of human leptospirosis LFIs against microagglutination tests (MAT) or immunofluorescent assays (IFA) were searched from PubMed, Embase, and Scopus, and selected as per pre-set inclusion and exclusion criteria. A total of 49 data entries extracted from 24 eligible records published between 2003 and 2023 were included for meta-analysis. A meta-analysis was performed using STATA. The quality of the included studies was assessed according to the revised QUADAS-2. Only nine studies (32.1%) were considered to have a low risk of bias and no concern for applicability. Pooled sensitivity and specificity were calculated to be 68% (95% confidence interval, CI: 57-78) and 93% (95% CI: 90-95), respectively. However, the ranges of sensitivity (3.6 - 100%) and specificity (53.5 - 100%) of individual entries are dramatically broad, possibly due to the heterogeneity found in both study designs and LFIs themselves. Subgroup analysis demonstrated that IgM detection has better sensitivity than detection of IgG alone. Moreover, the test performance seems to be unaffected by samples from different phases of infection.
CONCLUSIONS: The pooled specificity of LFIs observed is somewhat acceptable, but the pooled sensitivity is low. These results, however, must be interpreted with caution because of substantial heterogeneity. Further evaluations of the LFIs with well-standardized design and reference test will be needed for a greater understanding of the test performance. Additionally, IgM detection type should be employed when leptospirosis LFIs are developed in the future.
RESULTS: Original articles reporting the accuracy of human leptospirosis LFIs against microagglutination tests (MAT) or immunofluorescent assays (IFA) were searched from PubMed, Embase, and Scopus, and selected as per pre-set inclusion and exclusion criteria. A total of 49 data entries extracted from 24 eligible records published between 2003 and 2023 were included for meta-analysis. A meta-analysis was performed using STATA. The quality of the included studies was assessed according to the revised QUADAS-2. Only nine studies (32.1%) were considered to have a low risk of bias and no concern for applicability. Pooled sensitivity and specificity were calculated to be 68% (95% confidence interval, CI: 57-78) and 93% (95% CI: 90-95), respectively. However, the ranges of sensitivity (3.6 - 100%) and specificity (53.5 - 100%) of individual entries are dramatically broad, possibly due to the heterogeneity found in both study designs and LFIs themselves. Subgroup analysis demonstrated that IgM detection has better sensitivity than detection of IgG alone. Moreover, the test performance seems to be unaffected by samples from different phases of infection.
CONCLUSIONS: The pooled specificity of LFIs observed is somewhat acceptable, but the pooled sensitivity is low. These results, however, must be interpreted with caution because of substantial heterogeneity. Further evaluations of the LFIs with well-standardized design and reference test will be needed for a greater understanding of the test performance. Additionally, IgM detection type should be employed when leptospirosis LFIs are developed in the future.
摘要：
背景：在过去的二十年中，已开发并商业化了几种用于诊断人类钩端螺旋体病的快速侧流免疫分析（LFIs）。然而,这些LFI的准确性和可靠性还没有得到很好的理解。在这项研究中,我们旨在通过系统评价和荟萃分析评估钩端螺旋体病LFI的准确性以及影响检测效率的因素.
结果：从PubMed搜索了报告人类钩端螺旋体病LFI对微凝集试验（MAT）或免疫荧光测定（IFA）准确性的原始文章，Embase,还有Scopus,并根据预先设定的纳入和排除标准进行选择。从2003年至2023年发布的24条合格记录中提取的49条数据条目被纳入荟萃分析。使用STATA进行荟萃分析。根据修订的QUADAS-2评估纳入研究的质量。只有9项研究（32.1％）被认为具有低偏倚风险且不关心适用性。合并的敏感性和特异性计算为68%(95%置信区间，CI：57-78）和93%（95%CI：90-95），分别。然而,单个条目的灵敏度（3.6-100%）和特异性（53.5-100%）的范围非常广泛，可能是由于在研究设计和LFI本身中发现的异质性。亚组分析表明，IgM检测比单独检测IgG具有更好的灵敏度。此外，测试性能似乎不受感染不同阶段的样品的影响。
结论：观察到的LFI的合并特异性在某种程度上是可以接受的，但合并敏感性较低。这些结果,然而,由于实质性的异质性，必须谨慎解释。为了更好地了解测试性能，需要对具有良好标准化设计和参考测试的LFI进行进一步评估。此外,将来开发钩端螺旋体病LFI时，应采用IgM检测类型。
结果：从PubMed搜索了报告人类钩端螺旋体病LFI对微凝集试验（MAT）或免疫荧光测定（IFA）准确性的原始文章，Embase,还有Scopus,并根据预先设定的纳入和排除标准进行选择。从2003年至2023年发布的24条合格记录中提取的49条数据条目被纳入荟萃分析。使用STATA进行荟萃分析。根据修订的QUADAS-2评估纳入研究的质量。只有9项研究（32.1％）被认为具有低偏倚风险且不关心适用性。合并的敏感性和特异性计算为68%(95%置信区间，CI：57-78）和93%（95%CI：90-95），分别。然而,单个条目的灵敏度（3.6-100%）和特异性（53.5-100%）的范围非常广泛，可能是由于在研究设计和LFI本身中发现的异质性。亚组分析表明，IgM检测比单独检测IgG具有更好的灵敏度。此外，测试性能似乎不受感染不同阶段的样品的影响。
结论：观察到的LFI的合并特异性在某种程度上是可以接受的，但合并敏感性较低。这些结果,然而,由于实质性的异质性，必须谨慎解释。为了更好地了解测试性能，需要对具有良好标准化设计和参考测试的LFI进行进一步评估。此外,将来开发钩端螺旋体病LFI时，应采用IgM检测类型。
