Sensitive and specific serodiagnosis of Lyme disease by enzyme-linked immunosorbent assay with a peptide based on an immunodominant conserved region of Borrelia burgdorferi VlsE

VlsE, the variable surface antigen of Borrelia burgdorferi, contains an imm unodominant conserved region named IR,, In the present study, the diagnosti c performance of a peptide enzyme-linked immunosorbent assay (ELISA) based on a 26-mer synthetic peptide (C-6) with the IR, sequence was explored, Sen sitivity was assessed with serum samples (n = 210) collected from patients with clinically defined Lyme disease at the acute (early Localized or early disseminated disease), convalescent, or late disease phase, The sensitivit ies for acute-, convalescent-, and late-phase specimens were 74% (29 of 39) , 85 to 90% (34 of 40 to 35 of 39), and 100% (59 of 59), respectively. Seru m specimens from early neuroborreliosis patients were 95% positive (19 of 2 0), and those from an additional group of patients with posttreatment Lyme disease syndrome yielded a sensitivity of 62% (8 of 13), To assess the spec ificity of the peptide ELISA, 77 serum samples from patients with other spi rochetal or chronic infections, autoimmune diseases, or neurologic diseases and 99 serum specimens from hospitalized patients in an area where Lyme di sease is not endemic were examined. Only two potential false positives from the hospitalized patients were found, and the overall specificity was 99% (174 of 176), Precision, which was assessed with a panel of positive and ne gative serum specimens arranged in blinded duplicates, was 100%. Four serum samples with very high anti-OspA antibody titers obtained from four monkey s given the OspA vaccine did not react with the C-6 peptide. This simple, s ensitive, specific, and precise ELISA may contribute to alleviate some of t he remaining problems in Lyme disease serodiagnosis. Because of its synthet ic peptide base, it will be inexpensive to manufacture. It also will be app licable to serum specimens from OspA-vaccinated subjects.