IP Library Granted Patent US 12,385,909
Granted Patent B2
US 12,385,909 · App. 17/962,125 · Granted Aug 12, 2025

System for detecting infection in synovial fluid

Inventors: Carl Deirmengian (Newton Square, PA); Richard C. Birkmeyer (Landenberg, PA); Keith Kardos (Bethlehem, PA); Patrick Kilmartin (Rochester, NY); Alexander Cameron (Cherry Hill, NJ); Kevin Schiller (Phoenixville, PA); Eun Kyung Chung (Avondale, PA)
Assignee: CD Diagnostics, Inc.
G01N33/54388G01N33/5748G01N33/6869G01N33/6893G01N2333/515G01N2333/535G01N2333/5412G01N2333/5421G01N2333/5428G01N2333/545G01N2333/7158G01N2333/72G01N2333/795G01N2333/966G01N2800/10G01N2800/26G01N2800/60G01N2800/7095
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Quick Facts
Patent No.
US 12,385,909
App. No.
17/962,125
Granted
Aug 12, 2025
Kind
B2
Abstract

The invention provides methods and systems for detecting a biomarker in a synovial fluid wherein the system also includes a control to ensure that the test sample is indeed synovial fluid. The biomarkers and the control for synovial fluid can be identified using proteomic methods, including but not limited to antibody based methods, such as an enzyme-linked immunosorbant assay (ELISA), a radioimmunoassay (RIA), or a lateral flow immunoassay.

Claims (9)

1. A system for diagnosing joint infection in a subject, wherein the system detects the presence of a biomarker for joint infection in synovial fluid obtained from the subject and in contact with a buffer to maintain a pH in a range of from about 5 to about 9, wherein detection of the biomarker diagnoses joint infection in the subject with at least 90% accuracy, wherein the biomarker is selected from the group consisting of IL-1α, HNP1-3, ELA-2, bacterial permeability increasing protein (BPI), neutrophil gelatinase-associated lipocalin (NGAL), Resistin, Thrombospondin, Lactoferrin, IL-1β, IL-8, C-reactive protein (CRP), TNFα, IL-6, HNE, a2M, vascular endothelial growth factor (VEGF), fibroblast growth factor 2 (FGF2), skin derived antileukoproteinase (SKALP), IP-10, leukocyte-derived matrix metalloproteinase (LMP), and Orsomucoid, and any combination thereof, wherein the system comprises:

a) a first region comprising a first detection reagent that detects the presence of the biomarker for joint infection in synovial fluid, wherein the first detector reagent specifically binds the biomarker,

b) a second region comprising an internal control detector reagent comprising aggrecan for verification of synovial fluid, wherein the internal control detector reagent specifically binds a marker of synovial fluid;

wherein joint infection is diagnosed when the biomarker and the marker of synovial fluid are detected and the first region and second region are in flow communication with each other.

2. The system of claim 1 , wherein the system is capable of diagnosing joint infection when the marker for synovial fluid is detected at a higher signal intensity than the biomarker, by the system.

3. The system of claim 1 , wherein the biomarker is IL-1α.

4. The system of claim 2 , wherein the marker of synovial fluid is selected from the group consisting of hyaluronic acid (HA), mucopolysaccharide, glucosamine, chondroitin sulfate cartilage oligomeric matrix protein, lumican, lubricin, and any combination thereof.

5. The system of claim 1 , wherein the system has a sensitivity and specificity of at least 90% for joint infection.

6. The system of claim 1 , wherein the joint is selected from the group consisting of a native joint and a replacement joint.

Continuity (4)
Continuation 16142550 · Sep 26, 2018
Continuation 14371965
Provisional Application 61590234 · Jan 24, 2012
Related Publication 20230058794A1 · Feb 23, 2023
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