莱姆病血清学检测的前瞻性研究。
Prospective study of serologic tests for lyme disease.
作者信息
Steere Allen C, McHugh Gail, Damle Nitin, Sikand Vijay K
机构信息
Center for Immunology and Inflammatory Diseases, Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
出版信息
Clin Infect Dis. 2008 Jul 15;47(2):188-95. doi: 10.1086/589242.
BACKGROUND
Tests to determine serum antibody levels-the 2-tier sonicate immunoglobulin M (IgM) and immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA) and Western blot method or the IgG of the variable major protein-like sequence-expressed (VlsE) sixth invariant region (C6) peptide ELISA method-are the major tests available for support of the diagnosis of Lyme disease. However, these tests have not been assessed prospectively.
METHODS
We used these tests prospectively to determine serologic responses in 134 patients with various manifestations of Lyme disease, 89 patients with other illnesses (with or without a history of Lyme disease), and 136 healthy subjects from areas of endemicity and areas in which the infection was not endemic.
RESULTS
With 2-tier tests and the C6 peptide ELISA, only approximately one-third of 76 patients with erythema migrans had results that were positive for IgM or IgG seroreactivity with Borrelia burgdorferi in acute-phase samples. During convalescence, 3-4 weeks later, almost two-thirds of patients had seroreactivity with the spirochete B. burgdorferi. The frequencies of seroreactivity were significantly greater among patients with spirochetal dissemination than they were among those who lacked evidence of disseminated disease. Of the 44 patients with Lyme disease who had neurologic, heart, or joint involvement, all had positive C6 peptide ELISA results, 42 had IgG responses with 2-tier tests, and 2 patients with facial palsy had only IgM responses. However, among the control groups, the IgG Western blot was slightly more specific than the C6 peptide ELISA. The differences between the 2 test systems (2-tier testing and C6 peptide ELISA) with respect to sensitivity and specificity were not statistically significant.
CONCLUSIONS
Except in patients with erythema migrans, both test systems were sensitive for support of the diagnosis of Lyme disease. However, with current methods, 2-tier testing was associated with slightly better specificity.
背景
用于测定血清抗体水平的检测方法——两层超声裂解物免疫球蛋白M（IgM）和免疫球蛋白G（IgG）酶联免疫吸附测定（ELISA）以及蛋白质印迹法，或可变主要蛋白样序列表达（VlsE）第六恒定区（C6）肽ELISA法——是目前可用于支持莱姆病诊断的主要检测方法。然而，这些检测方法尚未经过前瞻性评估。
方法
我们前瞻性地使用这些检测方法，以确定134例有莱姆病各种表现的患者、89例患有其他疾病（有或无莱姆病病史）的患者以及136例来自疾病流行地区和非流行地区的健康受试者的血清学反应。
结果
采用两层检测法和C6肽ELISA法时，在76例游走性红斑患者中，急性期样本中仅有约三分之一的患者针对伯氏疏螺旋体的IgM或IgG血清反应呈阳性。在恢复期，即3至4周后，近三分之二的患者针对螺旋体伯氏疏螺旋体呈血清反应阳性。螺旋体播散患者的血清反应频率显著高于无播散性疾病证据的患者。在44例有神经、心脏或关节受累的莱姆病患者中，所有患者的C6肽ELISA结果均为阳性，42例患者两层检测法的IgG反应呈阳性，2例面神经麻痹患者仅呈IgM反应。然而，在对照组中，蛋白质印迹法IgG比C6肽ELISA法略具特异性。两种检测系统（两层检测法和C6肽ELISA法）在敏感性和特异性方面的差异无统计学意义。
结论
除游走性红斑患者外，两种检测系统对支持莱姆病的诊断均敏感。然而，就目前的方法而言，两层检测法的特异性略好。
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