Patent ID: 8906635

Claim:
A method of diagnosing Clostridium difficile -associated diarrhea (CDAD) or Clostridium difficile infection (CDI) in a stool specimen of a subject, the method comprising detecting in the stool specimen an increase in a level of a non-muscle tropomyosin polypeptide, or fragment thereof, with an antibody, or antigen-binding portion thereof, that specifically binds the non-muscle tropomyosin polypeptide, or fragment thereof; and detecting the presence of a C-terminal 250-amino-acid fragment of Clostridium difficile toxin B polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2, or fragment thereof, with an antibody, or antigen-binding portion thereof, that specifically binds the C-terminal 250-amino-acid fragment of Clostridium difficile toxin B polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2, or fragment thereof, wherein the increase in the level of the non-muscle tropomyosin polypeptide, or fragment thereof, and the presence of the C-terminal 250-amino-acid fragment of Clostridium difficile toxin B polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2, or fragment thereof, is diagnostic for CDAD or CDI in the subject.