title: Serodiagnosis of Lyme disease: accuracy of a two-step approach using a flagella-based ELISA and immunoblotting.
abstract: An ELISA containing a purified flagellar antigen from Borrelia burgdorferi (FLA-ELISA) was evaluated. The FLA-ELISA, detecting IgM and IgG together, did not have adequate specificity by itself. Good accuracy was obtained, however, when the FLA-ELISA was the first step in a two-step protocol that used immunoblotting as a conditional second test. Samples that scored positive or equivocal by the FLA-ELISA were evaluated with separate IgM and IgG immunoblots. The sensitivity of the two-step process for patients with erythema migrans or with later manifestations of Lyme disease was 64% and 100%, respectively. The specificity for health blood donors was 100% and was 90% for the aggregate of all persons with illness that may cause serologic cross-reactivity (98% if the samples from relapsing fever patients were excluded). Test precision was 96% overall, 99% for Lyme disease case serum samples, 100% for specimens from blood donors, and 88% for samples from persons with other illness.
authors.affiliation: Division of Vector-Borne Infectious Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention Ft. Collins, Colorado 80522, USA.
authors.forename: B J
authors.initials: BJ
authors.lastname: Johnson
authors.forename: K E
authors.initials: KE
authors.lastname: Robbins
authors.forename: R E
authors.initials: RE
authors.lastname: Bailey
authors.forename: B L
authors.initials: BL
authors.lastname: Cao
authors.forename: S L
authors.initials: SL
authors.lastname: Sviat
authors.forename: R B
authors.initials: RB
authors.lastname: Craven
authors.forename: L W
authors.initials: LW
authors.lastname: Mayer
authors.forename: D T
authors.initials: DT
authors.lastname: Dennis
mesh_terms: D000942:Antigens, Bacterial; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005069:Evaluation Studies as Topic; D005407:Flagella / Q000276:immunology*; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis*; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial