Method and compositions for analysis of pentraxin receptors as indicators of disease

• US 6,872,541 B2
• Filed: 07/25/2001
• Issued: 03/29/2005
• Est. Priority Date: 07/25/2001
• Status: Expired due to Fees

• Current Assignee: Coulter International Corp.
• Original Assignee: Coulter International Corp.
• Inventors: Mills, Rhonda Ann
• Primary Examiner(s): Lankford, Jr., Leon B.
• Assistant Examiner(s): DAVIS, RUTH A
• Application Number:
  US09/915,892
• Publication Number:
  US 20030022245A1
• Time in Patent Office: 1,343 Days
• Field of Search: 435/4, 435/5, 435/7.1, 435/7.2, 435/7.21
• US Class Current: 435/7.21
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/564 for pre-existing immune complex or autoimmune disease , i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9

Abstract

A kit for assessing the level of pentraxin-binding moieties on particles in a biological sample containing a ligand comprising a pentraxin is useful in a method of assessing pentraxin-binding of particles for use in diagnosis of disease or abnormality. The method includes the steps of (a) exposing a biological test sample containing particles that comprise a pentraxin-binding receptor from a test subject to a ligand comprising a pentraxin in the presence of calcium; (b) determining quantitatively the level of binding between particles and ligand in said test sample; and (c) comparing the level of binding in said test sample to the level of binding in a control biological sample containing said particles from a healthy subject of the same species as the subject supplying the test sample. A change in the level of binding in said test sample from that of the control sample is indicative of disease or abnormality.

Claims

1. A kit comprising:

(a) a ligand comprising a pentraxin,

(b) a buffer solution containing calcium ions, and

(c) an additional ligand that binds to a moiety on particles that is not pentraxin-binding.

2. The kit according to claim 1, wherein said additional ligand is selected from the group consisting of CD64, CD14, CD16, CD45RA, CD33, CD142 and HLA-DR.

3. The kit according to claim 1, comprising a first detectable marker that labels said pentraxin and a different second detectable marker that labels said additional ligand.

4. The kit according to claim 1, further comprising a detectable marker for labeling said pentraxin ligand.

5. The kit according to claim 1, further comprising at least one component selected from the group consisting of:

suitable vessels for containing samples, suitable controls or tables of normal values of pentraxin-binding receptors, instructions for using said ligand and buffer for performing said calcium-dependent assay, instructions for preparing the controls, suitable diluents and buffers for the samples, indicator charts for signal comparisons, disposable gloves, decontamination instructions, applicator sticks or containers, and sample preparator cups.

6. The kit according to claim 1, wherein said particles are of mammalian origin.

7. The kit according to claim 1, wherein said particles are of non-mammalian origin.

8. The kit according to claim 1, wherein said pentraxin is C-reactive protein (CRP).

9. The kit according to claim 1, wherein said pentraxin is selected from the group consisting of serum amyloid P (SAP), TNF-stimulated gene 14 (TSG-14) or PTX3, neuronal pentraxin 1 (NPR1), neuronal pentraxin 2 (NPR2), guinea pig apexin/p50, and rat neural activity-regulated pentraxin (narp).

10. The kit according to claim 1, wherein said particles are selected from the group consisting of leucocytes, mast cells, macrophages, progenitor cells, platelets, endothelial cells fibroblasts, neurons, microglial cells, platelets, and bacterial cells.

11. The kit according to claim 1, wherein said buffer contains calcium ions in a concentration of from 0.5 mM to 5 mM.

12. The kit according to claim 1, wherein said biological sample is selected from the group consisting of whole blood, peripheral blood, synovial fluid, cerebrospinal fluid, saliva, tissue, bone marrow, lymph node and a cell line established from mammalian cells.

13. The kit according to claim 1, wherein said level of pentraxin-binding moieties is associated with disease.

14. The kit according to claim 13, wherein said disease is selected from the group consisting of an immune disorder, an auto-immune disorder, cancer, an inflammatory disorder, sepsis and a bacterial infection.

15. The kit according to claim 14 wherein said disorder is selected from the group consisting of diabetes, multiple sclerosis, Sjorgen'"'"'s Syndrome rheumatoid arthritis, and systemic lupus erythematosis.

16. The kit according to claim 1, wherein said assay is a fluorescent activated particle sorting assay.

17. A kit comprising:

(a) a ligand comprising a pentraxin, and

(b) an additional ligand that binds to a moiety on particles that is not pentraxin-binding.