Evaluation of four commercially available ELISA assays for the serologic diagnosis of Lyme disease.

We evaluated four commercially available ELISAs for detection of antibody to Borrelia burgdorferi with 21 sera from patients with clinically diagnosed Lyme disease and 89 patient control sera. Patient control sera included 28 sera from patients with rheumatoid arthritis (RA), 17 sera from patients with systemic lupus erythematosus (SLE), and 44 sera containing antibodies reported to cross-react in some Lyme disease tests. The ELISAs tested (Cambridge Bioscience, Diamedix, 3M, and Zeus) detect antibodies (IgM and/or IgG) that bind Borrelia burgdorferi antigen attached to microtiter wells. Antibody reactivity in the sera from patients with clinically diagnosed Lyme disease was characterized by using Zeus immunoglobulin class-specific assays (IgM and IgG). Sensitivities in early and late Lyme disease were as follows: Cambridge and Diamedix, 57% and 100%; 3M, 57% and 93%; and Zeus, 71% and 86%. Reactivities within a patient control population were: Cambridge and Diamedix, 3%; 3M, 7%; and Zeus, 10%.