title: Comparative evaluation of three different ELISA methods for the diagnosis of early culture-confirmed Lyme disease in Italy.
abstract: In this study the raising and development of the immune response to Borrelia burgdorferi infection in 45 Italian patients suffering from culture-confirmed Lyme borreliosis erythema migrans was investigated. A total of 95 serially collected serum samples were tested by using three different commercial ELISAs: recomWell Borrelia (Mikrogen), Enzygnost Borreliosis (DADE Behring) and Quick ELISA C6 Borrelia (Immunetics). The sensitivities of the ELISAs were as follows: Enzygnost Borreliosis IgM, 70.5 %; Quick ELISA C6 Borrelia, 62.1 %; recomWell Borrelia IgM, 55.7 %; recomWell Borrelia IgG, 57.9 %; and Enzygnost Borreliosis IgG, 36.8 %. In order to compare the specificity values of the three ELISAs, a panel of sera obtained from blood donors (210 samples coming from a non-endemic area and 24 samples from an endemic area) was tested, as well as sera from patients suffering from some of the most common biological conditions that could result in false-positive reactivity in Lyme disease serology (n = 40). RecomWell Borrelia IgG and recomWell Borrelia IgM were the most specific (97.1 % and 98.9 %, respectively), followed by Quick ELISA C6 Borrelia (96.7 %). Enzygnost Borreliosis IgG and IgM achieved 90.1 % and 92.3 % specificity, respectively. Sera that gave discrepant results when tested by the three ELISAs were further analysed by Western blotting.
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Marangoni
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Sparacino
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Cavrini
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Storni
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Mondardini
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Sambri
authors.affiliation: Sezione di Microbiologia - DMCSS, University of Bologna, St Orsola Hospital, via Massarenti 9, Bologna, Italy 2Centro di Riferimento Regionale per le Emergenze Microbiologiche, Ospedale Policlinico S. Orsola, Bologna, Italy 3Division of Infectious Diseases, Ospedale di Belluno, Belluno, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cevenini
mesh_terms: D025065:Borrelia burgdorferi / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005189:False Positive Reactions; D006801:Humans; D007558:Italy; D008193:Lyme Disease / Q000097:blood / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity