Borrelia burgdorferi VlsE antigen for the serological diagnosis of Lyme borreliosis.

In this study the raising and development of the antibody response to Borrelia burgdorferi infection in 66 Italian patients suffering from culture-confirmed Lyme borreliosis erythema migrans (EM) was investigated. 62/66 cultures obtained from the biopsies were identified as B. afzelii by PCR A total of 175 serially collected serum samples were tested by using two different sets of commercial assays: Enzygnost® Lyme link VlsE/IgG and Enzygnost® Borreliosis IgM (DADE Behring, Marburg, Germany) and LIAISON® Borrelia IgG and IgM (Saluggia Italy). Considering only samples obtained at first presentation when EM was clinically evident, 49/66 patients (72.4%) were IgG or IgM positive by Enzygnost®, whereas 33/66 (50.0%) patients were IgG or IgM positive by LIAISON®. Taking into account the follow up period, 8 patients sero-converted for IgG or IgM by Enzygnost® and 4 by LIAISON®. Similar and very good specificity values were obtained by all the methods, by testing sera obtained from blood donors (n=300) and from patients suffering from some of the most common biological conditions possibly resulting in false-positive reactivity in Lyme disease serology (n=100): Enzygnost® Lyme link VlsE/IgG was the more specific (98.3%), followed by LIAISON® Borrelia IgG (96.5%); considering IgM tests, Enzygnost® Borreliosis IgM showed to be 95.3%% specific, whereas the LIAISON® Borrelia IgM was 92.8% specific. Recombinant VlsE antigens obtained from all the three B.burgdorferi genospecies pathogenic to humans, included in Enzygnost® Lyme link VlsE/IgG, greatly improved serodiagnosis of Lyme disease.