Predictive value of
The present invention relates to the field of Clostridium difficile infections. Methods of diagnosing, treating and preventing Clostridium difficile -associated disease and recurrent CDAD are disclosed herein.
1. An in vitro method comprising:
a) providing a sample from a human subject diagnosed with Clostridium difficile -Associated Disease (CDAD) and at risk of developing a recurrent CDAD or severe form of CDAD;
b) quantitating in the sample IgG antibodies specifically binding the C. difficile toxin antigen TcdA, IgG antibodies specifically binding the C. difficile toxin antigen TcdB, IgG antibodies specifically binding the C. difficile antigen FliD, and IgM antibodies specifically binding the C. difficile antigen FliD; and
c) administering to the human subject a treatment or an immunogenic composition against C. difficile infection when at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are not quantitated in the sample; and
not administering to the human subject a treatment or an immunogenic composition against C. difficile infection when at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are quantitated in the sample.
2. The method of claim 1 , further comprising a step of isolation and identification of a bacterial strain of C. difficile.
3. The method of claim 1 , further comprising quantifying IgA antibodies in the sample.
4. The method of claim 1 , wherein the sample is selected from the group consisting of: blood, cordblood, lactoserum, saliva and feces.
5. The method of claim 1 , wherein at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are not quantitated in the sample; and
wherein a treatment or an immunogenic composition against C. difficile infection is administered to the human subject.
6. The method of claim 1 , wherein at least 0.38 μg/mL of IgG antibodies specifically binding the C. difficile toxin antigen TcdA, at least 1.56 μg/mL IgG antibodies specifically binding the C. difficile toxin antigen TcdB, at least 1.86 μg/mL IgG antibodies specifically binding the C. difficile antigen FliD, and at least 0.65 μg/mL IgM antibodies specifically binding the C. difficile antigen FliD, are quantitated in the sample; and
wherein a treatment or an immunogenic composition against C. difficile infection is not administered to the human subject.