酶联免疫吸附试验诊断人类钩端螺旋体病：文献的荟萃分析。
Enzyme-linked immunosorbent assay to diagnose human leptospirosis: a meta-analysis of the published literature.
机构信息
Consejo Nacional de Investigaciones Científicas y Técnicas, Instituto Nacional de Tecnología Agropecuaria EEA Rafaela, Provincia de Santa Fe, Argentina.
出版信息
Epidemiol Infect. 2013 Jan;141(1):22-32. doi: 10.1017/S0950268812001951. Epub 2012 Sep 7.
Abstract
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.
摘要
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。
相似文献
1
Enzyme-linked immunosorbent assay to diagnose human leptospirosis: a meta-analysis of the published literature.酶联免疫吸附试验诊断人类钩端螺旋体病：文献的荟萃分析。
Epidemiol Infect. 2013 Jan;141(1):22-32. doi: 10.1017/S0950268812001951. Epub 2012 Sep 7.
2
Recombinant ligA for leptospirosis diagnosis and ligA among the Leptospira spp. clinical isolates.用于钩端螺旋体病诊断的重组连接蛋白A以及钩端螺旋体属临床分离株中的连接蛋白A
J Microbiol Methods. 2008 Jan;72(1):73-81. doi: 10.1016/j.mimet.2007.10.012. Epub 2007 Nov 17.
3
Development of in-house ELISAs as an alternative method for the serodiagnosis of leptospirosis.建立内部 ELISA 作为钩端螺旋体病血清学诊断的替代方法。
Int J Infect Dis. 2021 Apr;105:135-140. doi: 10.1016/j.ijid.2021.01.074. Epub 2021 Feb 5.
4
Detection of Leptospira-specific antibodies using a recombinant antigen-based enzyme-linked immunosorbent assay.应用重组抗原酶联免疫吸附试验检测钩端螺旋体特异性抗体。
Am J Trop Med Hyg. 2013 Dec;89(6):1088-94. doi: 10.4269/ajtmh.13-0041. Epub 2013 Oct 28.
5
6
Evaluation of recombinant Leptospira antigen-based enzyme-linked immunosorbent assays for the serodiagnosis of leptospirosis.基于重组钩端螺旋体抗原的酶联免疫吸附测定法用于钩端螺旋体病血清学诊断的评估。
J Clin Microbiol. 2001 Sep;39(9):3303-10. doi: 10.1128/JCM.39.9.3303-3310.2001.
7
Nucleic acid and antigen detection tests for leptospirosis.钩端螺旋体病的核酸和抗原检测试验
Cochrane Database Syst Rev. 2019 Aug 1;8(8):CD011871. doi: 10.1002/14651858.CD011871.pub2.
8
Evaluation of a modified Taqman assay detecting pathogenic Leptospira spp. against culture and Leptospira-specific IgM enzyme-linked immunosorbent assay in a clinical environment.在临床环境中，对一种检测致病性钩端螺旋体属的改良Taqman检测法与培养法及钩端螺旋体特异性IgM酶联免疫吸附测定法的评估。
Diagn Microbiol Infect Dis. 2007 Apr;57(4):361-6. doi: 10.1016/j.diagmicrobio.2006.10.004. Epub 2006 Dec 22.
9
Detection of LipL32-specific IgM by ELISA in sera of patients with a clinical diagnosis of leptospirosis.通过 ELISA 检测临床诊断为钩端螺旋体病患者血清中的 LipL32 特异性 IgM。
Pathog Glob Health. 2013 Apr;107(3):130-5. doi: 10.1179/2047773213Y.0000000088.
10
Advancing serologic diagnosis: assessing the efficacy of rErpY-like protein in human leptospirosis detection.推进血清学诊断：评估 rErpY 样蛋白在人类钩端螺旋体病检测中的功效。
Braz J Microbiol. 2024 Sep;55(3):2279-2284. doi: 10.1007/s42770-024-01364-4. Epub 2024 May 28.
引用本文的文献
1
Leptospirosis.钩端螺旋体病
Nat Rev Dis Primers. 2025 May 2;11(1):32. doi: 10.1038/s41572-025-00614-5.
2
Prevalence of leptospirosis among soldiers: A systematic review.士兵中钩端螺旋体病的患病率：一项系统评价。
PLoS Negl Trop Dis. 2025 Mar 17;19(3):e0012927. doi: 10.1371/journal.pntd.0012927. eCollection 2025 Mar.
3
Into the spotlight: A spatial study of potentially underreported leptospirosis among dengue-negative patients in São Paulo city, Brazil.聚焦：巴西圣保罗市登革热阴性患者中可能报告不足的钩端螺旋体病的空间研究。
PLoS Negl Trop Dis. 2025 Mar 5;19(3):e0012888. doi: 10.1371/journal.pntd.0012888. eCollection 2025 Mar.
4
An Unusual Presentation of Leptospirosis: A Case of Septic Shock and Proteinuria.钩端螺旋体病的一种不寻常表现：一例感染性休克和蛋白尿病例。
Cureus. 2024 Jul 20;16(7):e64982. doi: 10.7759/cureus.64982. eCollection 2024 Jul.
5
Leptospirosis seroprevalence and risk factors among slaughterhouse workers in Burkina Faso.布基纳法索屠宰场工人中钩端螺旋体病血清流行率及危险因素
IJID Reg. 2023 Oct 30;9:125-130. doi: 10.1016/j.ijregi.2023.10.008. eCollection 2023 Dec.
6
Role of Diagnostics in Epidemiology, Management, Surveillance, and Control of Leptospirosis.诊断在钩端螺旋体病的流行病学、管理、监测及控制中的作用
Pathogens. 2022 Mar 24;11(4):395. doi: 10.3390/pathogens11040395.
7
Diagnostic method-based underestimation of leptospirosis in clinical and research settings; an experience from a large prospective study in a high endemic setting.基于诊断方法的临床和研究环境中钩端螺旋体病低估；在高流行地区进行的大型前瞻性研究中的经验。
PLoS Negl Trop Dis. 2022 Apr 4;16(4):e0010331. doi: 10.1371/journal.pntd.0010331. eCollection 2022 Apr.
8
Leptospirosis as a cause of fever associated with jaundice in the Democratic Republic of the Congo.刚果民主共和国发热伴黄疸病例中钩端螺旋体病的病因。
PLoS Negl Trop Dis. 2021 Aug 17;15(8):e0009670. doi: 10.1371/journal.pntd.0009670. eCollection 2021 Aug.
9
Seroprevalence of Leptospirosis among High-Risk Individuals in Morocco.摩洛哥高危人群中钩端螺旋体病的血清阳性率
Interdiscip Perspect Infect Dis. 2020 May 20;2020:5236045. doi: 10.1155/2020/5236045. eCollection 2020.
10
An unusual case of fulminant leptospiral myocarditis: a case report.暴发性钩端螺旋体性心肌炎一例：病例报告
Eur Heart J Case Rep. 2019 Oct 21;3(4):1-5. doi: 10.1093/ehjcr/ytz180. eCollection 2019 Dec.
本文引用的文献
1
Evaluation of high performance liquid chromatography purified leptospiral antigen for the diagnosis of leptospirosis.评价高效液相色谱纯化钩端螺旋体抗原在钩端螺旋体病诊断中的应用。
Jpn J Infect Dis. 2009 Nov;62(6):428-31.
2
Invited review: Use of meta-analysis in animal health and reproduction: methods and applications.特邀综述：荟萃分析在动物健康与繁殖中的应用：方法与应用
J Dairy Sci. 2009 Aug;92(8):3545-65. doi: 10.3168/jds.2009-2140.
3
Leptospiral glycolipoprotein as a candidate antigen for serodiagnosis of human leptospirosis.钩端螺旋体糖脂蛋白作为人类钩端螺旋体病血清学诊断的候选抗原。
Lett Appl Microbiol. 2009 Aug;49(2):267-73. doi: 10.1111/j.1472-765X.2009.02650.x. Epub 2009 May 28.
4
Synthetic peptide issued from Hap1/LipL32 for new early serodiagnosis of human leptospirosis.合成肽来源于 Hap1/LipL32，用于人类钩端螺旋体病的早期血清学诊断。
Comp Immunol Microbiol Infect Dis. 2010 Sep;33(5):375-87. doi: 10.1016/j.cimid.2009.01.001. Epub 2009 Mar 23.
5
Diagnosis of leptospirosis by recombinant antigen based single serum dilution ELISA.基于重组抗原的单血清稀释酶联免疫吸附测定法诊断钩端螺旋体病
Indian J Med Res. 2008 Aug;128(2):172-7.
6
Clinical characteristics and risk factors of human leptospirosis in Argentina (1999-2005).阿根廷人钩端螺旋体病的临床特征及危险因素（1999 - 2005年）
Acta Trop. 2008 Sep;107(3):255-8. doi: 10.1016/j.actatropica.2008.06.007. Epub 2008 Jul 12.
7
Recombinant ligA for leptospirosis diagnosis and ligA among the Leptospira spp. clinical isolates.用于钩端螺旋体病诊断的重组连接蛋白A以及钩端螺旋体属临床分离株中的连接蛋白A
J Microbiol Methods. 2008 Jan;72(1):73-81. doi: 10.1016/j.mimet.2007.10.012. Epub 2007 Nov 17.
8
[Diagnosis of leptospirosis: evaluation of a solid-phase enzyme immunoassay in different stages of the disease].[钩端螺旋体病的诊断：疾病不同阶段固相酶免疫测定法的评估]
Rev Panam Salud Publica. 2007 Jun;21(6):388-95. doi: 10.1590/s1020-49892007000500007.
9
Evaluation of four whole-cell Leptospira-based serological tests for diagnosis of urban leptospirosis.评估四种基于钩端螺旋体全细胞的血清学检测方法用于诊断城市型钩端螺旋体病
Clin Vaccine Immunol. 2007 Sep;14(9):1245-8. doi: 10.1128/CVI.00217-07. Epub 2007 Jul 25.
10
Polymerase chain reaction in comparison with serological tests for early diagnosis of human leptospirosis.聚合酶链反应与血清学检测在人类钩端螺旋体病早期诊断中的比较。
Trop Med Int Health. 2006 Nov;11(11):1699-707. doi: 10.1111/j.1365-3156.2006.01727.x.
Zotero 插件