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The United States of America as Represented by the Department of Health

The Government of the United States of America, as Represented by the

David W Dorward

Claude F Garon

Tom G Schwan

Gary Davis

Edward D Huguenel

The invention relates to novel antigens associated with Borrelia burgdorferi which are exported (or shed) in vivo and whose detection is a means of diagnosing Lyme disease. The antigens are extracellular membrane vesicles and other bioproducts including the major extracellular protein. The invention further provides antibodies, monoclonal and/or polyclonal, labeled and/or unlabeled, that react with the antigens. The invention relates to a method for immune capture of specific microorganisms for their subsequent cultivation. The invention is also directed to a method of diagnosing Lyme disease by detecting the antigens in a biological sample taken from a host using the antibodies in conventional immunoassay formats. The invention further relates to kits, for the diagnosis of Lyme disease, comprising the antibodies and ancillary reagents. The advantage of the antibodies used in the invention is that they react with the antigens from geographically diverse strains of Borrelia burgdorferi, but do not react with antigens from related Borrelia spirochetes.

Methods and antibodies for the immune capture and detection of Borrelia

Methods for purifying and detecting IgM antibodies employ binding substances which are Borellia burgdorferi cells, or cellular or extracellular components obtained or derived therefrom and which bind to this class of antibodies. The binding substances may be attached to a solid substrate and then the substrate contacted with a solution containing IgM antibodies under conditions such that the antibodies bind to the binding substance on the substrate. The substrate is then contacted with a solution that releases the IgM antibodies from the substrate and the antibodies are recovered or detected. Applications of these methods include, for example, assays for diagnosing diseases which elicit primary and/or secondary IgM antibody-mediated immunity.

Methods for purifying and detecting IGM antibodies

The invention relates to novel antigens associated with Borrelia burgdorferi which are exported (or shed) in vivo and whose detection is a means of diagnosing Lyme disease. The antigens are extracellular membrane vesicles and other bioproducts including the major extracellular protein. The invention further provides antibodies, monoclonal and/or polyclonal, labeled and/or unlabeled, that react with the antigens. The invention is also directed to a method of diagnosing Lyme disease by detecting the antigens in a biological sample taken from a host using the antibodies in conventional immunoassay formats. The invention further relates to kits, for the diagnosis of Lyme disease, comprising the antibodies and ancillary reagents. The advantage of the antibodies used in the invention is that they react with the antigens from geographically diverse strains of Borrelia burgdorferi, but do not react with antigens from related Borrelia spirochetes.

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Hamilton, MT, United States of America

David W Dorward