US 12,385,909 B2
System for detecting infection in synovial fluid
Carl Deirmengian, Newton Square, PA (US); Richard C. Birkmeyer, Landenberg, PA (US); Keith Kardos, Bethlehem, PA (US); Patrick Kilmartin, Rochester, NY (US); Alexander Cameron, Cherry Hill, NJ (US); Kevin Schiller, Phoenixville, PA (US); and Eun Kyung Chung, Avondale, PA (US)
Assigned to CD Diagnostics, Inc., Claymont, DE (US)
Filed by CD DIAGNOSTICS, INC., Claymont, DE (US)
Filed on Oct. 7, 2022, as Appl. No. 17/962,125.
Application 17/962,125 is a continuation of application No. 16/142,550, filed on Sep. 26, 2018, granted, now 11,499,970.
Application 16/142,550 is a continuation of application No. 14/371,965, granted, now 10,139,405, previously published as PCT/US2012/061350, filed on Oct. 22, 2012.
Claims priority of provisional application 61/590,234, filed on Jan. 24, 2012.
Prior Publication US 2023/0058794 A1, Feb. 23, 2023
Int. Cl. G01N 33/543 (2006.01); G01N 33/574 (2006.01); G01N 33/68 (2006.01)
CPC G01N 33/54388 (2021.08) [G01N 33/5748 (2013.01); G01N 33/6869 (2013.01); G01N 33/6893 (2013.01); G01N 2333/515 (2013.01); G01N 2333/535 (2013.01); G01N 2333/5412 (2013.01); G01N 2333/5421 (2013.01); G01N 2333/5428 (2013.01); G01N 2333/545 (2013.01); G01N 2333/7158 (2013.01); G01N 2333/72 (2013.01); G01N 2333/795 (2013.01); G01N 2333/966 (2013.01); G01N 2800/10 (2013.01); G01N 2800/26 (2013.01); G01N 2800/60 (2013.01); G01N 2800/7095 (2013.01)] 6 Claims
 
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.