Mathiesen M J, Christiansen M, Hansen K, Holm A, Asbrink E, Theisen M
Department of Clinical Biochemistry, Statens Serum Institut, Copenhagen, Denmark.
J Clin Microbiol. 1998 Dec;36(12):3474-9. doi: 10.1128/JCM.36.12.3474-3479.1998.
Sera from 210 patients with Lyme borreliosis (LB) were studied by an enzyme-linked immunosorbent assay (ELISA) based on a synthetic peptide (pepC10) comprising the C-terminal 10-amino-acid residues of OspC of Borrelia burgdorferi. We found that 36.3 and 45.0% of the serum samples from patients with erythema migrans (EM) and neuroborreliosis (NB), respectively, displayed immunoglobulin M (IgM) anti-pepC10 reactivities, while these samples rarely (</=8%) displayed IgG antibody reactivities. Sera from patients with acrodermatitis chronica atrophicans did not contain anti-pepC10 antibodies. The diagnostic performance of this newly developed peptide ELISA was compared with those of an ELISA based on the full-length recombinant OspC protein (rOspC) and a commercially available ELISA based on the B. burgdorferi flagellum (Fla). The sensitivity of the IgM pepC10 ELISA was slightly lower (P < 0.04) than that of the rOspC ELISA for EM patients (36.3 versus 43.8%), while there was no difference for NB patients (45.0 versus 48.0%). However, the optical density values obtained by the pepC10 ELISA were generally higher than those obtained by the rOspC ELISA, leading to a significantly better quantitative discrimination between seropositive patients with NB and controls (P < 0.008). The specificity of the pepC10 ELISA was similar to those of the rOspC ELISA and the Fla ELISA for relevant controls including patients with syphilis and mononucleosis. Although the overall diagnostic sensitivity of the Fla ELISA was superior, 8.8 and 12.0% of the EM and NB patients, respectively, were antibody positive only by the pepC10 ELISA. Thus, use of a diagnostic test for LB based on the detection of IgM antibodies to pepC10 and Fla has increased sensitivity for the diagnosis of early LB.
采用基于合成肽（pepC10）的酶联免疫吸附测定（ELISA）法，对210例莱姆病（LB）患者的血清进行了研究。该合成肽包含伯氏疏螺旋体OspC的C端10个氨基酸残基。我们发现，分别有36.3%和45.0%的游走性红斑（EM）患者和神经莱姆病（NB）患者的血清样本显示出免疫球蛋白M（IgM）抗pepC10反应性，而这些样本很少（≤8%）显示出IgG抗体反应性。慢性萎缩性肢端皮炎患者的血清不含抗pepC10抗体。将这种新开发的肽ELISA的诊断性能与基于全长重组OspC蛋白（rOspC）的ELISA以及基于伯氏疏螺旋体鞭毛（Fla）的市售ELISA的诊断性能进行了比较。对于EM患者，IgM pepC10 ELISA的敏感性略低于rOspC ELISA（P < 0.04）（36.3%对43.8%），而对于NB患者则无差异（45.0%对48.0%）。然而，pepC10 ELISA获得的光密度值通常高于rOspC ELISA获得的值，从而在NB血清阳性患者与对照之间实现了显著更好的定量区分（P < 0.008）。对于包括梅毒和单核细胞增多症患者在内的相关对照，pepC10 ELISA的特异性与rOspC ELISA和Fla ELISA相似。尽管Fla ELISA的总体诊断敏感性更高，但分别有8.8%和12.0%的EM和NB患者仅通过pepC10 ELISA呈抗体阳性。因此，基于检测针对pepC10和Fla的IgM抗体的LB诊断试验提高了早期LB诊断的敏感性。
