The 83-kDa
antigen of Borrelia burgdorferi was expressed as a
recombinant protein in Escherichia coli and purified for use in an
enzyme-linked
immunosorbent assay (p83-ELISA).
Antibodies to the 83-kDa
antigen of both the
immunoglobulin G (
IgG) and
IgM isotypes could be detected in all stages of
Lyme disease. Sensitivity varied, depending on the clinical stage of illness. In early stages, as defined for 118 patients with
erythema migrans, it was found to be 20% (24 of 118 patients: 7 with
IgM, 16 with
IgG, and 1 with
IgM and
IgG). Of the patients with late-stage
Lyme arthritis and
acrodermatitis chronica atrophicans, 94% (16 of 17:2 with
IgM and
IgG and 14 with
IgG) and 86% (36 of 42:2 with
IgG and
IgM and 34 with
IgG) revealed positive results in the p83-ELISA, respectively. p83 displays sequence heterogeneity according to the genomospecies, but when the reactions of serum specimens from
acrodermatitis chronica atrophicans patients and
arthritis patients with p83 derived from representative strains of B. burgdorferi sensu stricto and Borrelia afzelii in ELISAs were compared, no differences in specificity and sensitivity were seen. When 82 serum specimens from healthy controls were tested, none had
IgG and only 3 (4%) had
IgM antibodies, indicating a high specificity. Positive reactions with
antibodies against Treponema pallidum (1 of 37 patients;
IgG) and Epstein-Barr virus (1 of 44 patients;
IgM) and with
autoantibodies of various specificities (1 of 53 patients;
IgG) were seen with < 3% of the serum samples te11111111111111111111 high speficicity for B. burgdorferi.2+ 13% for
IgM antibodies, the
IgM p83-ELISA provided little diagnostic information for
Lyme disease, whereas the
IgG p83-ELISA appears to be a suita ;e test for serodiagnosis of advanced-stage
Lyme disease.