A mu-capture
enzyme-linked
immunosorbent assay (ELISA) for detection of serum
immunoglobulin M (
IgM)
antibodies to Borrelia burgdorferi by using biotinylated purified B. burgdorferi flagella was developed. The diagnostic performance of the mu-capture ELISA was compared with that of a conventional indirect ELISA. Sera from untreated patients with
erythema migrans (n = 50), neuroborreliosis (n = 100), and
acrodermatitis chronica atrophicans (ACA; n = 48) were investigated. The cutoff of the ELISAs was adjusted to a diagnostic specificity of 98% on the basis of examination of 200 serum specimens from healthy controls. The mu-capture ELISA increased the diagnostic sensitivity in patients with
erythema migrans from 32 to 48% (P less than 0.01) and in patients with neuroborreliosis from 37 to 57% (P less than 0.001). Because of an increased signal/noise ratio, the mu-capture ELISA yielded a significantly better quantitative discrimination of individual positive measurements from the cutoff (P less than 0.001). The increased signal/noise ratio was most likely a consequence of the elimination of
IgG competition for the test
antigen. This may also explain why 12% of patients with ACA showed significantly increased specific
IgM levels only by the mu-capture ELISA. Of patients with ACA, 27% had
IgM rheumatoid factor. The mu-capture principle with a directly labeled
antigen showed no interference with
IgM rheumatoid factor, in contrast to the indirect ELISA. The high diagnostic performance and ease of this three-step mu-capture ELISA make it suitable for routine anti-B. burgdorferi
IgM serodiagnosis.