Surface antigens and proteins useful in compositions for the diagnosis and prevention of Lyme disease

Abstract

A novel isolated surface antigen, which is expressed in vitro by spirochetes of Borrelia garinii strain IP90, is characterized by a relative molecular mass of 39.5 kDa and the ability to induce antibodies which kill spirochetes of the B. burgdorferi sensu lato strain IP90 by ADCK in vitro. Novel B. garinii cassette string protein or fragments thereof are also useful, as is the P39.5 protein in diagnosing Lyme disease and in compositions for treatment or prophylaxis thereof.

What is claimed is:  
     
         1 . An isolated, recombinant, or synthetic protein or fragment thereof that binds with antibodies to the causative agent of Lyme Disease in infected humans or animals, wherein said protein is a homolog of a protein having the amino acid sequence formed by reading in frame the sequence of SEQ ID NO: 14 followed by SEQ ID NO: 2, and wherein said fragment comprises at least 5 consecutive amino acids in length of said protein and wherein said protein or fragment has up to four conservative amino acid substitutions at homologous amino acid positions in the amino acid sequence formed by reading in frame the sequence of SEQ ID NO: 14 followed by SEQ ID NO: 2 or fragments thereof.  
     
     
         2 . The protein according to  claim 1 , wherein said protein is expressed by spirochetes of a  B. burgdorferi  sensu latostrain.  
     
     
         3 . The protein or fragment according to  claim 1 , having at least 50% identity with a protein having the amino acid sequence formed by reading in frame the sequence of SEQ ID NO: 14 followed by SEQ ID NO: 2.  
     
     
         4 . The protein or fragment according to  claim 1 , having at least 85% identity with a protein having the amino acid sequence formed by reading in frame the sequence of SEQ ID NO: 14 followed by SEQ ID NO: 2.  
     
     
         5 . The protein or fragment according to  claim 1 , wherein said fragment is at least eight amino acids in length.  
     
     
         6 . The protein or fragment according to  claim 1 , wherein said protein or fragment is coupled to a substrate that immobilizes said protein or fragment.  
     
     
         7 . The protein or fragment according to  claim 1 , wherein said protein or peptide is coupled to a detectable label or signal-α-generating reagent.  
     
     
         8 . A kit for diagnosing infection with a causative agent of Lyme Disease in a human or animal comprising a protein or fragment of  claim 1 , and at least one of the group consisting of a substrate that immobilizes said protein or peptide, a detectable label, a labeled conjugate, and a signal generating reagent.