Systems and methods for detection of analytes in biological fluids

• US 20050042696A1
• Filed: 08/09/2004
• Published: 02/24/2005
• Est. Priority Date: 05/03/2001
• Status: Active Grant

• Current Assignee: Victor Kovalenko
• Original Assignee: Victor Kovalenko
• Inventors: Kovalenko, Victor
• Granted Patent: US 7,125,517 B2
• Time in Patent Office: Days
• US Class Current: 435/7.500
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54353 with ligand attached to the carrier via a chemical coupling agent coatings G01N33/54393

Abstract

The invention provides a heterogeneous immunoassay for detection of antibodies and antigens based on specific antigen-antibody immune complex formation with multiple antigen-bearing conjugate components. The invention further provides means for optimizing the assay format for the detection of both low and high-affinity antibodies, and provides means for quantitative detection of both antibody and the corresponding antigen present in a sample.

Claims

1-31. -31. (canceled)

32. A kit comprising a first component comprising a ligand linked, through a chemical spacer, to a solid phase adsorbing composition, a second component comprising a ligand-binding moiety conjugated to an antigen or hapten that binds an antibody to be detected in a sample and a third component comprising the antigen or hapten conjugated to a label.

34. The kit of claim 32, wherein the second and third components are supplied as dry samples or liquid samples, wherein the dry or liquid samples may be separate or mixtures of the second and third components.

35. The kit of claim 32, wherein the second and third components comprise more than one antigen or hapten molecule.

41. The kit of claim 32, wherein the first component is biotin linked, through a polyethylene glycol spacer, to an albumin, the second component and the third component each comprise two or more different antigens or haptens that are chemically linked to the ligand-binding moiety or the detector label, respectively.

42. The kit of claim 32, wherein the second component is avidin or streptavidin conjugated to the antigen or hapten.

43. The kit of claim 32, wherein the antibody to be detected in the sample is an antimicrobial antibody.

44. The kit of claim 32, wherein the sample was taken from a human or animal having a microbial infection.

45. The kit claim 44, wherein the microbial infection in Lyme disease.

46. The kit of claim 32, wherein the antigen is C6 peptide derived from VLSe protein of B. burgdorferi.

47. The kit of claim 32, wherein the antigen is C10 peptide derived from OspC protein of B. burgdorferi.

48. The kit of claim 32, wherein the antigens are peptides derived from VLSe protein (C6) and OspC protein (C10) of B. burgdorferi.

49. The kit of claim 32, further comprising instructions for practicing the method of detecting an antibody in a sample.

33. (Canceled)

36-40. -40. (Canceled)