莱姆病的血清学诊断：采用基于鞭毛的酶联免疫吸附测定（ELISA）和免疫印迹法两步法的准确性

Serodiagnosis of Lyme disease: accuracy of a two-step approach using a flagella-based ELISA and immunoblotting.

作者信息

Johnson B J, Robbins K E, Bailey R E, Cao B L, Sviat S L, Craven R B, Mayer L W, Dennis D T

机构信息

Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention Ft. Collins, Colorado 80522, USA.

出版信息

J Infect Dis. 1996 Aug;174(2):346-53. doi: 10.1093/infdis/174.2.346.

DOI:10.1093/infdis/174.2.346

PMID:8699065

Abstract

An ELISA containing a purified flagellar antigen from Borrelia burgdorferi (FLA-ELISA) was evaluated. The FLA-ELISA, detecting IgM and IgG together, did not have adequate specificity by itself. Good accuracy was obtained, however, when the FLA-ELISA was the first step in a two-step protocol that used immunoblotting as a conditional second test. Samples that scored positive or equivocal by the FLA-ELISA were evaluated with separate IgM and IgG immunoblots. The sensitivity of the two-step process for patients with erythema migrans or with later manifestations of Lyme disease was 64% and 100%, respectively. The specificity for health blood donors was 100% and was 90% for the aggregate of all persons with illness that may cause serologic cross-reactivity (98% if the samples from relapsing fever patients were excluded). Test precision was 96% overall, 99% for Lyme disease case serum samples, 100% for specimens from blood donors, and 88% for samples from persons with other illness.

摘要

对一种含有来自伯氏疏螺旋体的纯化鞭毛抗原的酶联免疫吸附测定（FLA-ELISA）进行了评估。该FLA-ELISA同时检测IgM和IgG，其本身特异性不足。然而，当FLA-ELISA作为两步检测方案的第一步，第二步使用免疫印迹作为条件性检测时，获得了良好的准确性。通过FLA-ELISA检测呈阳性或疑似阳性的样本，用单独的IgM和IgG免疫印迹进行评估。对于患有游走性红斑或莱姆病后期表现的患者，两步检测法的敏感性分别为64%和100%。对健康献血者的特异性为100%，对于所有可能导致血清学交叉反应的患病者总体特异性为90%（如果排除回归热患者的样本，则为98%）。总体检测精度为96%，莱姆病病例血清样本为99%，献血者样本为100%，其他疾病患者样本为88%。