Evaluation of the Panbio Leptospira IgM ELISA among Outpatients Attending Primary Care in Southeast Asia.
Evaluation of the Panbio Leptospira IgM ELISA among Outpatients Attending Primary Care in Southeast Asia.
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DOI：
10.4269/ajtmh.20-0818
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发表时间：
2021-03-15
期刊：
影响因子：
--
通讯作者：
Blacksell SD
中科院分区：
文献类型：
--
作者：
Dhawan S;Althaus T;Lubell Y;Suwancharoen D;Blacksell SD
尽管估计表明钩端螺旋体属。该病在东南亚流行，但证据仍然有限。基于钩端螺旋体ELISA的诊断准确性评估主要依靠住院患者和重症患者；因此，测量社区病原体负担的研究可能不准确。我们对泰国清莱和缅甸仰光 Hlaing Tha Yar 初级保健的 656 名发热门诊患者进行了 Panbio 钩端螺旋体 ELISA IgM 评估。与我们的参考测试 PCR 检测相比，ELISA 证明使用制造商推荐的临界值检测急性钩端螺旋体感染的诊断准确性有限，灵敏度为 71.4%，特异性为 36.4%，受试者操作特征曲线下面积值为 0.65（95% CI：0.41-0.89）。 ELISA 作为检测近期接触钩端螺旋体的筛查工具也表现不佳。与“金标准”显微凝集试验相比，特异性为42.7%。我们的结论是，钩端螺旋体 IgM ELISA 在血清诊断和血清流行率方面的效用在我们的环境中受到限制。
Despite estimates suggesting Leptospira spp. being endemic in Southeast Asia, evidence remains limited. Diagnostic accuracy evaluations based on Leptospira ELISA mainly rely on hospitalized and severe patients; therefore, studies measuring the pathogen burden may be inaccurate in the community. We evaluated the Panbio Leptospira ELISA IgM among 656 febrile outpatients attending primary care in Chiangrai, Thailand, and Hlaing Tha Yar, Yangon, Myanmar. ELISA demonstrated limited diagnostic accuracy for the detection of acute leptospiral infection using the manufacturer recommended cutoff, with a sensitivity of 71.4% and specificity of 36.4%, and an area under the receiver operator characteristic curve value of 0.65 (95% CI: 0.41–0.89), compared with our reference test, the PCR assay. ELISA also performed poorly as a screening tool for detecting recent exposure to Leptospira spp. compared with the “gold-standard” microscopic agglutination test, with a specificity of 42.7%. We conclude that the utility of the Leptospira IgM ELISA for both serodiagnosis and seroprevalence is limited in our setting.
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