title: A first-tier rapid assay for the serodiagnosis of Borrelia burgdorferi infection.
abstract: BACKGROUND
  The present recommendation for the serologic diagnosis of Lyme disease is a 2-tier process in which a serum sample with a positive or equivocal result by an enzyme-linked immunosorbent assay (ELISA) or immunofluorescent assay is then followed by supplemental testing by Western blot. Our laboratory has developed recombinant chimeric proteins composed of key Borrelia epitopes. These novel antigens are consistent and are easily standardized.
  
  
  METHODS
  We adapted these recombinant proteins into a new immunochromatographic format that can be used as a highly sensitive and specific first-tier assay that can be used to replace the ELISA or immunofluorescent assay.
  
  
  RESULTS
  This rapid test was equally sensitive (P>.05) and more specific (P<.05) than a frequently used commercial whole cell ELISA. The overall clinical accuracy achieved on agreement studies among 3 Lyme research laboratories on clinically defined serum panels was shown to be statistically equivalent to the commercial ELISA. The assay can detect anti-Borrelia burgdorferi antibodies in either serum or whole blood.
  
  
  CONCLUSIONS
  This sensitive and specific rapid assay, which is suited for the physician's office, streamlines the 2-tier system by allowing the physician to determine if a Western blot is necessary at the time of the initial office visit.
authors.affiliation: Brook Biotechnologies, Inc, Stony Brook, NY, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Gomes-Solecki
authors.forename: G P
authors.initials: GP
authors.lastname: Wormser
authors.forename: D H
authors.initials: DH
authors.lastname: Persing
authors.forename: B W
authors.initials: BW
authors.lastname: Berger
authors.forename: J D
authors.initials: JD
authors.lastname: Glass
authors.forename: X
authors.initials: X
authors.lastname: Yang
authors.forename: R J
authors.initials: RJ
authors.lastname: Dattwyler
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D015153:Blotting, Western; D001899:Borrelia Infections / Q000175:diagnosis* / Q000276:immunology; D015748:Borrelia burgdorferi Group / Q000276:immunology*; D002845:Chromatography; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000032:analysis*; D005455:Fluorescent Antibody Technique; D006801:Humans; D011993:Recombinant Fusion Proteins / Q000032:analysis*; D012680:Sensitivity and Specificity
chemical_list: D000907:Antibodies, Bacterial; D000939:Epitopes; D011993:Recombinant Fusion Proteins