Granted Patent
B2
US 12,265,090 · App. 17/404,841 · Granted Apr 1, 2025
Inter-alpha inhibitor proteins
Assignee:
ProThera Biologics, Inc.
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Abstract
Described herein are methods for quantifying IAIP levels in a sample.
Claims (24)
1. A method for quantifying intact inter-alpha inhibitor protein (IAIP) in a sample from a subject comprising:
a) contacting the sample with a binding agent to produce an IAIP-binding agent complex, wherein the binding agent is bound to a support, and wherein the binding agent comprises an antibody that specifically binds to bikunin;
b) contacting the IAIP-binding agent complex with a detection agent, wherein the detection agent comprises an IAIP ligand that binds to at least one IAIP heavy chain and does not bind to free bikunin, and wherein the IAIP ligand is selected from the group consisting of endotoxin (LPS), heparin, a histone, vitronectin, fibronectin, laminin, tenascin C, aggrecan, von Willebrand Factor, pentraxin-3 (PTX3), TNF-stimulated gene-6 (TSG-6), factor IX, a complement component, factor XIIIa, and tissue transglutaminase; and
c) detecting an amount of the detection agent bound to the IAIP-binding agent complex, wherein the intact IAIP comprises bikunin and at least one IAIP heavy chain selected from the group consisting of H1, H2, and H3 chain;
thereby quantifying the intact IAIP in the sample.
2. The method of claim 1 , wherein the contacting in step a) and/or b) is performed at a pH of about 7.0 to about 3.5.
3. The method of claim 2 , wherein the pH is about 5.0 to about 3.5.
4. The method of claim 3 , wherein the pH is about 4.0.
5. The method of claim 1 , further comprising, prior to or during step a), adding a divalent cation to the sample.
6. The method of claim 1 , wherein the subject is a human subject.
7. The method of claim 1 , wherein the IAIP ligand is heparin or a histone.
8. The method of claim 7 , wherein the IAIP ligand is heparin.
9. The method of claim 1 , wherein the detection agent comprises a label.
10. The method of claim 9 , wherein the label is biotin, a gold nanoparticle, a magnetic particle, a latex particle, an enzyme, an enzyme substrate, a fluorescent dye, a luminescent compound, or a radiolabel.
11. The method of claim 9 , wherein the label is an enzyme and wherein the enzyme is horseradish peroxidase.
12. The method of claim 9 , wherein the label comprises a gold nanoparticle.
13. The method of claim 9 , wherein the label comprises biotin and one of streptavidin or avidin.
14. The method of claim 9 , wherein the label is a gold nanoparticle and the IAIP ligand is heparin.
15. The method of claim 1 , wherein the sample comprises blood, urine, cerebrospinal fluid, synovial fluid, amniotic fluid, interstitial fluid, follicular fluid, peritoneal fluid, bronchoalveolar lavage fluid, breast milk, sputum, lymph, bile, or tissue homogenate.
16. The method of claim 15 , wherein the sample is blood, cerebrospinal fluid, bronchoalveolar lavage fluid, synovial fluid, or sputum.
17. The method of claim 16 , wherein the sample is blood.
18. The method of claim 17 , wherein the blood is plasma or serum.
19. The method of claim 1 , wherein the support is a plate, a particle, a nanoparticle, a resin, a membrane, a biochip, a container, a test strip, or a bead.
20. The method of claim 1 , wherein the support is a test strip.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 2, 2022
From: LIM, YOW-PIN; SPERO, DENICE
To: PROTHERA BIOLOGICS, INC.
Reel/Frame 061631/0595 →
Continuity (4)
Continuation
16608531
Provisional Application
62614333
· Jan 5, 2018
Provisional Application
62490003
· Apr 25, 2017
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