title: Recombinant assay for serodiagnosis of Lyme disease regardless of OspA vaccination status.
abstract: All current seroassays using cultured Borrelia burgdorferi as their antigen source have been rendered obsolete by the recombinant OspA Lyme disease vaccine. OspA is the major outer surface protein expressed in cultured B. burgdorferi, and any seroassay that uses whole organisms as its antigen source cannot differentiate between subjects who received the vaccine and those who were naturally infected. We developed a new sensitive and specific enzyme-linked immunosorbent assay (ELISA) utilizing recombinant chimeric borrelia proteins devoid of OspA (rNon-OspA) that can be used to detect antibodies to diagnostically important B. burgdorferi antigens in both OspA-vaccinated and nonvaccinated individuals. We tested sera from patients with Lyme disease and with conditions associated with false-positive serologies, OspA-vaccinated individuals, and healthy high-risk workers from an area of endemicity and normal sera from individuals from areas of nonendemicity. The rNon-OspA test was compared with two commercially available whole-cell immunoassays. The rNon-OspA assay is as sensitive and specific as the whole-cell assay (P > 0.05) for detection of anti-B. burgdorferi antibodies. However, the rNon-OspA assay can differentiate between populations comprised of naturally infected and OspA-vaccinated individuals (P < 0.05). Our data demonstrate that this new sensitive rNon-OspA ELISA can be used for the laboratory detection of B. burgdorferi antibodies regardless of vaccination status and could replace existing serologic assays for Lyme disease.
authors.affiliation: Brook Biotechnologies, Inc., Stony Brook, New York 11790-3350, USA.
authors.forename: Maria J C
authors.initials: MJ
authors.lastname: Gomes-Solecki
authors.forename: Gary P
authors.initials: GP
authors.lastname: Wormser
authors.forename: Martin
authors.initials: M
authors.lastname: Schriefer
authors.forename: Glenn
authors.initials: G
authors.lastname: Neuman
authors.forename: Laura
authors.initials: L
authors.lastname: Hannafey
authors.forename: John D
authors.initials: JD
authors.lastname: Glass
authors.forename: Raymond J
authors.initials: RJ
authors.lastname: Dattwyler
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000954:Antigens, Surface / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D001426:Bacterial Proteins / Q000235:genetics / Q000276:immunology*; D001428:Bacterial Vaccines; D025065:Borrelia burgdorferi / Q000235:genetics / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008074:Lipoproteins; D008193:Lyme Disease / Q000175:diagnosis* / Q000382:microbiology / Q000517:prevention & control; D022123:Lyme Disease Vaccines / Q000008:administration & dosage / Q000276:immunology; D011993:Recombinant Fusion Proteins / Q000276:immunology*; D012680:Sensitivity and Specificity; D014611:Vaccination; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001426:Bacterial Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; D022123:Lyme Disease Vaccines; C072045:OspA protein; D011993:Recombinant Fusion Proteins; D019444:Vaccines, DNA