Consejo Nacional de Investigaciones Científicas y Técnicas, Instituto Nacional de Tecnología Agropecuaria EEA Rafaela, Provincia de Santa Fe, Argentina.
Epidemiol Infect. 2013 Jan;141(1):22-32. doi: 10.1017/S0950268812001951. Epub 2012 Sep 7.
We report an evaluation of the accuracy of ELISA for the detection of Leptospira-specific antibodies in humans. Eighty-eight studies published in 35 articles met all inclusion criteria and were submitted to meta-analysis. Pooled sensitivity and specificity were 0·779 (95% CI 0·770-0·789) and 0·913 (95% CI 0·908-0·917), respectively, and the area under the curve was 0·964. Heterogeneity across studies was statistically significant, but none of the sources of heterogeneity (disease stage, antigen used, antibody detected) could fully explain this finding. Although the convalescent stage of disease was significantly associated with higher diagnostic accuracy, IgM ELISA was the best choice, regardless of the stage of disease. Negative ELISAs (IgG or IgM) applied in the acute phase do not rule out leptospirosis due to the possibility of false-negative results. In this case it is advisable to request a second blood sample or to apply a direct method for leptospiral DNA.
我们报告了一项评估 ELISA 检测人类钩端螺旋体特异性抗体准确性的研究。35 篇文章中发表的 88 项研究符合所有纳入标准，并进行了荟萃分析。合并后的敏感性和特异性分别为 0.779（95%CI 0.770-0.789）和 0.913（95%CI 0.908-0.917），曲线下面积为 0.964。研究之间的异质性具有统计学意义，但没有任何异质性来源（疾病阶段、使用的抗原、检测到的抗体）可以完全解释这一发现。尽管疾病的恢复期与更高的诊断准确性显著相关，但无论疾病阶段如何，IgM ELISA 都是最佳选择。由于可能出现假阴性结果，因此在急性阶段进行阴性 ELISA（IgG 或 IgM）检测并不能排除钩端螺旋体病。在这种情况下，建议采集第二份血样或应用直接检测钩端螺旋体 DNA 的方法。
