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1. (WO1993018784) ANTICORPS POLYCLONAUX MONOSPECIFIQUES DES TOXINES DE TYPE SHIGA
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WE CLAIM :

1. Purified IgG comprising high titer,
monospecific polyclonal antibodies to a Shiga-like toxin (SLT) .

2. The purified IgG of claim 1 wherein said IgG is bovine IgG.

3. The purified IgG of claim 2 wherein said antibodies have an average neutralizing titer of at least 1:250, 000/mg IgG and an average toxin-reactive antibody titer of at least 1:12, 000/mg IgG as measured by ELISA.

4. The purified IgG of claim 1 wherein said IgG is essentially free of IgG that does not react with said SLT.

5. High titer, monospecific, purified polyclonal antibodies to an SLT.

6. The antibodies of claim 5 wherein said
antibodies comprise bovine IgG.

7. A method for producing the purified IgG of claim 1 comprising the steps of:
inoculating an animal with a purified, active SLT, wherein the cell membranes of said animal do not contain a receptor for said SLT or contain only low levels of said receptor; and recovering purified IgG from said animal after said animal has had an immune response to said purified SLT.

8. The method of claim 7 wherein said animal is a pregnant cow.

9. A method for producing the purified polyclonal antibodies of claim 5 comprising the steps of:
inoculating an animal with a purified SLT, wherein the cell membranes of said animal do not contain a receptor for said SLT or contain only low levels of said receptor;
recovering purified IgG from said animal after said animal has had an immune response to said purified SLT; and
recovering the purified polyclonal antibodies of claim 5 by affinity chromatography wherein said purified SLT is bound to a chromatographic support.

10. A pharmaceutical composition for the
prevention, amelioration, or treatment of disease in a human or animal caused by an SLT or by bacteria that produce an SLT comprising an effective amount of the purified IgG of claim 1 in a pharmaceutically acceptable carrier.

11. A method for the passive immunization of a human or animal against SLT toxemia comprising
administering to said human or animal a prophylactically effective amount of the purified IgG of claim 1 to prevent said toxemia.

12. A method for the treatment of SLT toxemia in a human or animal comprising administering a therapeutically effective amount of the purified IgG of claim 1 to treat said toxemia to said human or animal.

13. A pharmaceutical composition for the
prevention, amelioration, or treatment of disease in an animal caused by an SLT or by bacteria that produce an SLT comprising an effective amount of high titer, monospecific polyclonal antibodies to said SLT in colostrum or milk.

14. The composition of claim 13 wherein said colostrum or milk has an average neutralizing titer of at least 1:100,000.

15. A method for making the composition of claim 13 comprising the steps of:
inoculating a pregnant cow with a purified SLT; and
milking said inoculated cow after said cow has had an immune response to said purified SLT to obtain colostrum or milk.

16. A method for the passive immunization of an animal against SLT toxemia or the treatment of SLT toxemia in said animal comprising the administration of an
effective amount of the composition of claim 13 to said animal.

17. A method for detecting the presence of an SLT or SLT-producing bacteria in a sample comprising the steps of:
contacting said sample with the purified IgG of claim 1; and
determining if an antibody-antigen reaction has occurred.

18. The method of claim 17 wherein said IgG is attached to a soluble or insoluble substrate.

19. The method of claim 17 wherein said IgG is attached to a solid support and said step of determining if an antibody-antigen reaction has occurred comprises the steps of:
contacting IgG-SLT complexes formed if said antibody-antigen reaction has occurred with a second antibody to said SLT, wherein said other antibody is labeled with a detectable moiety, thereby forming IgG-SLT-second antibody complexes;
removing unbound second antibody; and
detecting the presence of said detectable moiety.

20. The method of claim 19 wherein said IgG is bound to solid particles and the presence of said SLT is detected by the agglutination of said solid particles.

21. The method of claim 17 wherein said IgG is attached to latex beads and said step of determining if an antibody-antigen reaction has occurred comprises visually determining if said latex beads in said sample have
agglutinated.

22. A method for detecting the presence of an SLT in a sample comprising the steps of:
contacting said sample with a receptor to said SLT for a period of time and under reaction conditions sufficient for said receptor to bind to said SLT if said SLT is in said sample;
contacting any receptor-SLT complexes formed with the purified IgG of claim 1 for a sufficient period of time and under reaction conditions sufficient for said IgG to bind to said receptor-SLT complexes, thereby forming receptor-SLT-IgG complexes; and
detecting the presence or absence of said receptor-SLT-IgG complexes.

23. The method of claim 22 wherein said receptor is represented by the formula X-O-Y(R):
wherein Y is sphingosine, hydroxylated
sphingosine, or saturated sphingosine;

wherein X is a carbohydrate moiety selected from the group consisting of Gal(alphal-4)Gal, Gal(alphal-4) Gal (betal-4) Glc, GalNAc(betal-3) Gal (alphal-4) Gal (betal-4)Glc, GalNAc(betal-3)Gal(alphal-4)Gal, GalNAc(betal-3) Gal, and GalNAc; and
wherein R is H or a chemical group non-inhibitory to receptor binding and R is linked to the amine moiety of the sphingosine.

24. A method for detecting the presence or
concentration of an SLT in a sample comprising the steps of using said sample in an immunoassay wherein the purified IgG of claim 1 is used as a reagent in said immunoassay.

25. In a method for determining the presence or concentration of an SLT in a sample by employing an
immunoassay, the improvement comprising using the purified IgG of claim 1 as a reagent in said immunoassay.

26. A composition for the biochemical,
immunological, functional, or other investigational
analysis of an SLT, the improvement comprising an effective amount of the purified IgG of claim 1 in an acceptable carrier.

27. A reagent for use in an assay for the
detection of an SLT in a sample comprising the purified IgG of claim 1 in a liquid.

28. A reagent for use in an assay for the
detection of an SLT in a sample comprising the purified IgG of claim 1 attached to a substrate.

29. The reagent of claim 28 wherein said substrate is an insoluble solid support.

30. The reagent of claim 29 wherein said solid support is the well of a microtiter plate.

31. A reagent for use in an assay for the
detection of an SLT in a sample comprising the purified IgG of claim 1 attached to solid particles.

32. The reagent of claim 31 wherein said particles are latex beads.

33. A kit for detecting or measuring an SLT in a sample comprising, in a container:
the reagent of claim 39; and
means for detecting or measuring the complexes created by the binding of said SLT with the IgG in said reagent.

34. The kit of claim 33 wherein said detecting or measuring means comprises a reagent for use in an
immunoassay selected from the group consisting of
radioimmunoassay, enzyme-linked immunosorbent assay, and immunofluorescence assay.

35. The kit of claim 34 wherein said reagent contains a detectable moiety and is capable of binding to the complexes formed by said SLT and IgG.

36. The kit of claim 35 wherein said reagent comprises a receptor that binds to said SLT.

37. A kit for detecting or measuring an SLT in a sample comprising, in a container:
an SLT receptor attached to a solid support; and
the purified IgG of claim 1.

38. The kit of claim 37 further comprising means for detecting the binding of the anti-SLT antibodies in said purified IgG to SLT bound to said receptor.