System for detecting infection in synovial fluid
AssigneeCD Diagnostics, Inc.
InventorsCarl Deirmengian, Richard C. Birkmeyer, Keith Kardos, Patrick Kilmartin, Alexander Cameron, Kevin Schiller, Eun Kyung Chung
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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.
Claims21
1-22. (canceled)
A combination for diagnosing joint infection in a subject, comprising:
- protein or mRNA isolated from synovial fluid of the subject;
- and
- a first reagent configured to specifically detect the expression of neutrophil elastase 2 (ELA-2), bactericidal/permeability-increasing protein (BPI), neutrophil gelatinase-associated lipocalinllipocalin 2 (NGAL), resistin, thrombospondin, lactoferrin, alpha-2 macroglobulin (α2M), or interferon gamma-induced protein 10 (IP-10).
The system according to claim 2.3, wherein the first reagent is configured to detect between about 3,000 pg/ml and about 7,000 pg/ml IP-10.
A method of evaluating joint pain in a subject, comprising:
- isolating protein or mRNA from synovial fluid of a prosthetic joint of the subject;
- and
- contacting the protein or mRNA with a reagent configured to specifically detect the expression of neutrophil elastase 2 (ELA-2), bactericidal/permeability-increasing protein (BPI), neutrophil gelatinase-associated lipocalin/lipocalin 2 (NGAL), resistin, thrombospondin, lactoferrin, alpha-2 macroglobulin (α2M), or interferon gamma-induced protein 10 (IP-10).
A method of treating joint pain in a subject, the method comprising treating the subject with an anti-bacterial agent if a protein solution isolated from synovial fluid of the painful joint comprises:
- between about 400 ng/ml and about 28,000 ng/ml neutrophil elastase 2 (ELA-2);
- between about 800 ng/ml and about 3,600 ng/ml Neutrophil gelatinase-associated lipocalin/lipocalin 2 (NGAL);
- between about 30 ng/ml and about 150 ng/ml resistin;
- between about 100 ng/ml and about 170 ng/ml thrombospondin;
- between about 900 ng/ml and about 5,000 ng/ml lactofenin,
- between about 65 pg/ml and about 90 pg/ml alpha-2 macroglobulin (α2M);
- or
- between about 3,000 and about 7,000 pg/ml interferon gamma-induced protein 10 (IP-10).
Dependencies are inferred from the claim text.