AutoImmune Disorders is a result of a person’s immune system attacking their own body.

Antiphospholipid Syndrome

TEST CODE # R11006

Disease Information
The Antiphospholipid Antibody Panel offered by DevLab bio includes testing for autoantibodies that play a direct role in the pathogenesis of Antiphospholipid syndrome (APS). APS, also known as “Hughes syndrome”, is characterized by clinical features such as arterial/venous thromboses or recurrent miscarriages together with persistently positive tests for anti-phospholipid antibodies (aPLs). These antibodies include anti-cardiolipin and anti-B2-glycoprotein I antibodies and play a direct role in the pathogenesis of APS. Anti-cardiolipin antibodies may be observed by itself in some infectious diseases and may be observed in individuals with “secondary APS” that occurs in association with SLE or other rheumatic disorders, whereas anti-B2-glycoprotein I antibodies are specific for APS. Testing for anti-B2-glycoprotein I antibodies together with anti-cardiolipin antibodies provides a highly specific additional marker that allows APS to be distinguished from other clinical states. Additionally, testing for anti-B2-glycoprotein I antibodies can be helpful for APS diagnosis, particularly when anti-cardiolipin antibodies and lupus anticoagulant are negative and APS is strongly suspected. Testing for Cardiolipin IgG, IgM, IgA, B2-Glycoprotein I IgA, IgG, IgM.

Autoimmune Thyroid Disorder

TEST CODE # R11007

Disease Information
DevLab bio’s Thyroid Antibody Panel that includes both anti-TG and anti-TPO antibodies may assist physicians in diagnosing thyroid autoimmune disorders. Thryoid autoimmune disorders, such as Graves’ disease or Hashimoto’s thyroiditis, are in part characterized by the presence of autoantibodies against thyroid antigens, such as thyroglobulin (TG) or thyroid peroxidase (TPO). Over 98% of thyroiditis patients have either anti-TG and/or anti-TPO antibodies and in most cases, anti-TG and anti-TPO antibodies are observed together. Anti-TG antibodies are typically the first thyroid autoimmune markers to be observed followed by anti-TPO antibodies. Testing for Anti-TG and Anti-TPO.

Celiac Disease/Wheat Allergy


Disease Information
Celiac disease, a life-long condition in which ingestion of gluten, the water insoluble wheat gliadin and the prolamins in rye and barley, leads to chronic inflammation and damage of the small intestinal
mucosa. Additionally, it is widely accepted that dermatitis herpetiformis, a bullous skin disease, is induced by gluten. Tissue transglutaminase (tTG) has been identified as the major autoantigen in
celiac disease. IgA antibodies against tTG are highly disease specific serological markers for celiac disease and dermatitis herpetiformis. tTG IgG antibodies are less specific for these diseases but are helpful markers in patients with IgA deficiency. The alcohol-soluble polypeptides of gluten, the gliadins, are solely responsible for the toxic effects of gluten to the intestinal mucosa. Antibodies against deamidated gliadin, which are more specific B-cell epitopes than native gliadin, are highly specific markers for celiac disease and gluten sensitivity. Testing Tissue Transglutamine IgA & IgG.

Connective Tissue Diseases


Disease Information
Extractable nuclear antibodies (ENAs), also known as antinuclear antibodies (ANAs), are of central importance to clinical diagnosis of connective tissue diseases (CTDs) and includes antibodies against double-stranded DNA (dsDNA), Sm, U1RNP (RNP 70, A, C), SS-A/Ro, SS B/La, Scl-70, Centromere B, and Jo-1. Incidence of specific ENAs varies across different CTDs and testing for these specific ENAs can assist physicians in diagnosing patients with specific connective tissues diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), mixed connective tissue disease (MCTD), Sjögrens syndrome, scleroderma, and polymyositis/dermatomyositis. DevLab bio offers multiplexed ANA screen testing (w/dsDNA antibodies) as well as reflex testing for specific ENAs that can assist physicians in diagnosis of specific connective tissue diseases.

Primary Biliary Cirrhosis


Disease Information
DevLab bio also offers testing that may aid in diagnosis of some autoimmune liver diseases. Primary biliary cirrhosis (PBC) is a chronic, cholestatic liver disease which affects mainly middle-aged women. Anti-M2 antibodies are present in about 95% of patients with PBC. These antibodies specifically target mitochondria, specifically reacting with subunits of the 2-oxoacid-dehydrogenase complex (2-OADC) and, in most cases, the E2-subunit of pyruvate dehydrogenase (PDH-E2). Individuals who are positive for anti-M2 antibodies, even if they have no signs of cholestasis and/or liver inflammation, are very likely to develop PBC. A diagnosis of PBC is made “with confidence” when biochemical markers of cholestasis, particularly alkaline phosphatase, are elevated persistently for more than 6 months in the presence of anti-M2 antibodies and in the absence of an alternative explanation. Testing for Anti-M2.

Rheumatoid Arthritis

TEST CODE # R11004

Disease Information
Rheumatoid arthritis (RA) is one of the most common systemic autoimmune disorders. RA is characterized by chronic inflammation of the joints and may lead to progressive erosions and cartilage destruction. DevLab bio offers testing for multiple markers for RA that can aid in diagnosis; cyclic citrullinated peptide (CCP) IgG as well as both rheumatoid factor (RF) IgA and IgM. CCP IgG is a highly specific, but less sensitive, marker for RA while RF IgA and IgM are less specific but much more sensitive for RA. Additionally, RF constitutes one of the classification criteria proposed by the American College of Rheumatology (ACR) with about 80% of patients with RA having detectable RF antibodies. RF is also an important predictor of more severe disease, including extra articular manifestations or bone erosion and increased mortality; the higher the levels of RF antibodies, the higher the possibility of a more destructive articular disease. Finally, the prevalence of RA is markedly increased in individuals with RF antibodies of more than one isotype, most frequently a combination of RF IgA and IgM. In combination, testing for all three antibodies (CCP IgG, RF IgA, RF IgM) can assist physicians in a more accurate diagnosis. Testing CCP IgG, Rheumatoid Factor IgA, Rheumatoid Factor IgG.

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