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INOVA Diagnostics Inc. | Date: 2015-06-23

The present disclosure relates to the field of molecular biology and immunology. More specifically, the present disclosure provides compositions and methods for detecting anti-Th/To autoantibodies in the serum of subject with a systemic autoimmune disease, such as systemic sclerosis (SSc).

INOVA Diagnostics Inc. | Date: 2017-04-26

The present disclosure relates to the field of molecular biology and immunology. More specifically, the present disclosure provides compositions and methods for detecting anti-Th/To autoantibodies in the serum of subject with a systemic autoimmune disease, such as systemic sclerosis (SSc).

Mahler M.,INOVA Diagnostics Inc. | Miller F.W.,U.S. National Institutes of Health | Fritzler M.J.,University of Calgary
Autoimmunity Reviews | Year: 2014

Autoantibodies are a hallmark in the diagnosis of many systemic autoimmune rheumatic diseases (SARD) including idiopathic inflammatory myopathies (IIM). Based on their specificity, autoantibodies in IIM are grouped into myositis specific (MSA) and myositis associated autoantibodies (MAA). Among the MSA, autoantibodies against aminoacyl-tRNA synthetases (ARS) represent the most common antibodies and can be detected in 25-35% of patients. The presence of ARS and other autoantibodies has become a key feature for classification and diagnosis of IIM and is increasingly used to define clinically distinguishable IIM subsets. For example, anti-ARS autoantibodies are the key features of what has become known as anti-synthetase syndrome (aSS), characterized by multiple organ involvement, primarily interstitial lung disease, often accompanied by myositis, non-erosive arthritis, Raynaud's phenomenon, fever, and "mechanic's hands". Autoantibodies directed to eight different ARS have been described: Jo-1 (histidyl), PL-7 (threonyl), PL-12 (alanyl), OJ (isoleucyl), EJ (glycyl), KS (asparaginyl), Zo (phenylalanyl) and Ha (tyrosyl). Each anti-ARS antibody seems to define a distinctive clinical phenotype. Although several research methods and commercial tests are available, routine testing for anti-ARS autoantibodies (other than anti-Jo-1/histidyl-tRNA synthetase) is not widely available, sometimes leading to delays in diagnosis and poor disease outcomes. © 2014 Elsevier B.V.

Trouw L.A.,Leiden University | Mahler M.,INOVA Diagnostics Inc.
Autoimmunity Reviews | Year: 2012

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by inflammation and damage of the joints affecting about 0.5% of the general population. Early treatment in RA is important as it can prevent disease progression and irreversible damage of the joints. Despite the high diagnostic value of anti-citrullinated protein antibodies (ACPA) and rheumatoid factor (RF), there is a strong demand for novel serological biomarkers to further improve the diagnosis of this abundant disease. During the last decades, several autoantigens have been described in RA including Ra33 (hnRNP A2), fibrinogen, fibronectin, alpha-enolase, type II collagen, immunoglobulin binding protein (BiP), annexins and viral citrullinated peptide (VCP) derived from Epstein Barr Virus-encoded protein (EBNA-2). More recent discoveries include antibodies to carbamylated antigens (anti-CarP), to peptidyl arginine deiminase type 4 (PAD4), to BRAF (v raf murine sarcoma viral oncogene homologue B1) and to 14 autoantigens identified by phage display technology. This review provides a current overview of novel biomarkers for RA and discusses their future potential to improve the diagnosis of the disease. © 2012 Elsevier B.V.

INOVA Diagnostics Inc. and Leiden University | Date: 2015-07-22

The present disclosure relates to the field of molecular biology and more specifically to methods for detecting anti-carbamylated protein (anti-CarP) antibodies in the serum of rheumatoid arthritis (RA) patients.

News Article | November 16, 2016

SAN DIEGO, Nov. 16, 2016 /PRNewswire/ -- Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the US Food and Drug Administration (FDA) clearance of QUANTA Lite Calprotectin Extended Range, an assay which...

Mahler M.,INOVA Diagnostics Inc. | Fritzler M.J.,University of Calgary
Clinical and Developmental Immunology | Year: 2012

Antinuclear antibodies (ANAs) are a serological hallmark in the diagnosis of systemic autoimmune rheumatic diseases (SARD). The indirect immunofluorescence (IIF) assay on HEp-2 cells is a commonly used test for the detection of ANA and has been recently recommended as the screening test of choice by a task force of the American College of Rheumatology. However, up to 20% of apparently healthy individuals (HI) have been reported to have a positive IIF ANA test, primarily related to autoantibodies that target the dense fine speckles 70 (DFS70) antigen. Even more important, the DFS IIF pattern has been reported in up to 33% of ANA positive HI, but not in ANA positive SARD sera. Since the intended use of the ANA HEp-2 test is to aid in the diagnosis and classification of SARD, the detection and reporting of anti-DFS70 antibodies and their associated pattern (DFS) as a positive test significantly reduce the specificity and the positive likelihood of the ANA test. This has significant implications for medical management and diagnostic algorithms involving the detection of ANA. Recently, a novel immunoadsorption method has been developed that specifically blocks anti-DFS70 antibodies and, therefore, significantly increases the specificity of the ANA test for SARD. This immunoadsorption method has the potential to overcome a significant limitation of the ANA HEp-2 assay. The present paper summarizes the current knowledge about anti-DFS70 antibodies and their clinical impact on ANA testing. © 2012 Michael Mahler and Marvin J. Fritzler.

Lakos G.,INOVA Diagnostics Inc.
Seminars in Thrombosis and Hemostasis | Year: 2012

Antiphospholipid antibodies (aPL) are detected with two types of laboratory tests: first, antigen-specific immunoassays for the determination of antibodies against cardiolipin, glycoprotein I and other phospholipids, and phospholipidprotein complexes; second, functional (coagulation) assays for the detection of lupus anticoagulants. Both aPL immunoassays and coagulation assays are prone to interferences, and clinicians need to be aware of the limitations of these assays. Interference is a clinically significant bias in the measured analyte concentration due to the effect of another component or property of the sample. Besides immune-mediated interferences (such as heterophile or human anti-animal antibodies, rheumatoid factor, high immunoglobulin levels, or factor inhibitors), aPL assays are uniquely affected by anticoagulants and the presence of residual platelets in test plasma. Interferences are usually analyte- and assay-specific and may go unrecognized in routine laboratory practice. Despite advances in our knowledge on the mechanisms of interferences in aPL assays, it is unlikely that total elimination will be possible. Copyright © 2012 by Thieme Medical Publishers, Inc.

The present invention is in the field of diagnostics, and in particular to the early diagnosis of liver cirrhosis in a patient not known to have liver cancer by detecting and measuring circulating cartilage oligomeric matrix protein (COMP) alone or in conjunction with one or more additional liver cirrhosis biomarkers in the biological fluid of a subject.

Provided is a method for increasing the specificity of an antibody-based test to help in the diagnosis of autoimmune diseases by contacting a subjects sample with a blocking antigen prior interfering antibody present in the sample. More specifically, a method for increasing specificity of an antibody-based autoimmune disease assay comprising the steps of providing a sample from a subject, contacting the sample with a DFS70 derived antigen, reacting the sample with an autoimmune disease target and detecting antibodies to the autoimmune disease target is disclosed.

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