Flagellar Antigen Rapid Test for Detection of Antibodies to Borrelia

PRINCIPAL INVESTIGATOR: Levin, Andrew E. AWARDEE ORGANIZATION: Immunetics 380 Green Street Cambridge, MA 02139 TELEPHONE NUMBER: (617) 492-5416 AWARDEE NUMBER: 200-93-0666 The research program is aimed at providing a simple and reliable serological test which can be used in clinical laboratories, physicians' offices and field stations as an aid in the rapid diagnosis of Lyme Disease. The test is based on the use of microbeads coated with purified Borrelia burgdorferi flagellar antigen for the detection of specific antibodies in patient serum samples. Phase I will concentrate on development of the assay in a rapid test format. The performance of the test will be evaluated against defined serum panels and standard serological assays, including ELISA of whole spirochete sonicates and purified flagella. Performance goals will be high sensitivity and specificity, ease of use, low end-user cost, safe sample handling and storage requirements. In Phase II, the sensitivity and specificity of the test designed in Phase I will be evaluated and subjected to rigorous standardization by screening large numbers of human specimens of various geographical origins and nature (serum, cerebrospinal fluid and dried blood spot eluates). Modifications aimed at increasing specificity through the use of different flagellar antigen preparations, subfragments or synthetic peptides will be investigated. Scaled-up production techniques will be developed and further applicability of the test to species other than man will be explored.