Autoimmune DX

HUMAN provides in-vitro diagnostic products for medical laboratories, adhering to German quality standards. This includes high quality test systems for autoimmune diseases in the field of laboratory diagnostics.

For over 30 years, our products have been synonymous with high-quality, forward-thinking solutions in autoimmune diagnostics. ELISAs (enzyme linked immuno sorbent assay)and LIAs (line immunoassays) are developed and produced by a dedicated team of experts at our development and production site in Magdeburg.

Additionally, rapid screening tests are available, featuring disease-specific antigens, along with automated solutions for LIA and ELISA processing.

Explore our portfolio

• Rheumatology
• Hepatology
• Gastroenterology

• Endocrinology
• Instruments and Analyzers
• AID Technologies

Rheumatology

Comprehensive assay panel 

The field of rheumatology covers all systemic autoimmune rheumatic diseases (SARD) that target multiple tissues and/or organs, causing inflammation that can result in rashes, pain, discomfort and even death. The major targets of SARDs are connective tissue, joints, muscles and blood vessels.

• Connective Tissue Diseases (CTDs): These diseases affect the body's connective tissues, which include skin, blood vessels, and joints. Common CTDs include systemic lupus erythematosus and scleroderma. 

• Systemic Lupus Erythematosus (SLE): A systemic autoimmune disease where the immune system attacks healthy tissues, leading to organ inflammation e.g. in skin, kidneys, and joints

• Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA): RA is an autoimmune disorder that primarily affects joints, causing pain, swelling, and deformity. JIA is a similar condition in children under 16.

• Vasculitis: This group of diseases refers to inflammation of blood vessels, which can restrict blood flow thereby damaging vital organs and tissues.

• Antiphospholipid Syndrome (APS): An autoimmune disorder that causes abnormal blood clotting, leading to complications such as stroke, miscarriage, or deep vein thrombosis.

• Immune Complex Detection (complement system): Immune complexes (antibody-antigen clusters) accumulate in the bloodstream and tissues, causing inflammation and organ damage.

• Reactive Arthritis: An inflammatory condition triggered by an infection in another part of the body, typically affecting the joints, eyes, and urinary tract.

To differentiate the diverse and potentially overlapping syndroms, various technologies can be employed: ELISA as quanititative or qualitative tests as well as LIA for a overview of numerous antigens. 

Hepatology

Autoantibodies provoking permanent liver damage

HUMAN’s product line for autoimmune mediated liver diseases consists of both line immunoassays and ELISAs.
The IMTEC Liver-LIA provides the differential diagnosis by detection of autoantibodies specific for autoimmune hepatitis (AIH) as well as primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). The product range is completed by ELISAs for the quantitative determination of AMA-M2 and LKM-1 antibodies.

• Primary Biliary Cirrhosis (PBC): PBC is a chronic autoimmune disease in which the body's immune system gradually destroys the small bile ducts within the liver. This leads to bile build-up, liver inflammation, and eventually cirrhosis (liver scarring).
  
  

• Primary Sclerosing Cholangitis (PSC): PSC is another autoimmune disease affecting the bile ducts, causing inflammation and scarring that leads to blockages. This results in liver damage, liver failure and can increase the risk of liver cancer.
  
  

• Autoimmune Hepatitis (AIH): Autoimmune hepatitis (AIH) is a chronic inflammatory condition of the liver where the body's immune system mistakenly attacks healthy liver cells, leading to inflammation and liver damage. If untreated, it can progress to liver failure.

Gastroenterology

Autoantibodies associated with gastrointestinal diseases

The autoimmune product line for the detection of bowel diseases includes ELISAs for specific autoantibody markers for celiac disease, d-gliadin (DGP) and tissue transglutaminase (tTG).

The IMTEC-Gastro-LIA is used for the detection of IgA and IgG autoantibodies of autoimmune gastrointestinal diseases and carries five different antigens to identify autoantibodies in patients suffering from gastrointestinal autoimmune diseases like celiac disease and autoimmune gastritis.

• Celiac Disease: An autoimmune disorder in which the ingestion of gluten (found in wheat, barley, and rye) leads to damage in the small intestine. The immune system attacks the tissue, impairing nutrient absorption, causing gastrointestinal symptoms, and leading to malnutrition.
  
  

• Pernicious Anemia (Vitamin B12 deficiency induced Anemia): This condition is caused by the immune system attacking the stomach's parietal cells or intrinsic factor, leading to impaired absorption of vitamin B12. This results in anemia and neurological issues if untreated.
  
  

• Crohn’s Disease: A type of inflammatory bowel disease (IBD) where the immune system attacks the gastrointestinal tract, causing inflammation that can affect any part of the GI tract. Symptoms include abdominal pain, diarrhea, and weight loss.

Endocrinology

Autoantibodies involved in thyroid diseases

HUMAN’s endocrinology diagnostic covers autoimmune thyroid diseases (AITD), including Graves' disease (GD) and Hashimoto's thyroiditis (HT), both of which involve lymphocytic infiltration of the thyroid parenchyma. These conditions in endocrinology present 30% of all autoimmune disorders. For thorough assessment, HUMAN offers ELISA, CLIA and FIA assays that measure thyroid-stimulating hormone (TSH) and thyroid hormones (fT3 and fT4), ensuring precise evaluation of thyroid function in autoimmune endocrinology diagnostics.

• Autoimmune Hyperthyroidism – Graves’ Disease: An autoimmune disorder in which the immune system stimulates the thyroid gland to produce excessive amounts of thyroid hormones, leading to hyperthyroidism. Symptoms include weight loss, rapid heartbeat, anxiety, and bulging eyes (exophthalmos).
  
  

• Autoimmune Hypothyroidism – Hashimoto’s Disease: An autoimmune condition in which the immune system attacks the thyroid gland, causing inflammation and damage that leads to reduced thyroid hormone production (hypothyroidism). Symptoms include fatigue, weight gain, cold intolerance, and depression..

Instruments and Analyzer

Semi- to fully-automated LIA and ELISA processing

HUMAN’s autoimmune product line is completed by devices for the automated processing of ELISAs and line immunoassays.

Fully automated ELISA processing is available for 1, 2, or 4 plates, with the flexibility to perform different test combinations on each plate. For laboratories with lower throughput requirements, the HumaReader Single plus or HumaReader HS, combined with the Combiwash workstation, offers an efficient solution. Allmost all HUMAN-ELISAs come pre-programmed on HUMAN’s analyzers, with the option to add new applications as needed.

The HumaBlot 44^FA is a fully automated system for processing line immunoassays, handling everything from sample dilution and reagent management to strip scanning and test result interpretation. For manual processing of LIA results, the HumaScan software provides rapid, easy, and objective result interpretation.

The HumaScope FluoLED fluorescence microscope supports up to four fluorescence channels, enabling flexibility in working with various stainings, including but not limited to Immunofluorescence ANA staining.

Line Immunoassays (LIA) Technology

Autoimmune diseases are characterized by autoantibody detection in patient sera. HUMAN’s autoimmune line immunoassays (LIAs) are developed for rapid autoantibody profiling.

LIAs are simple-to-use for screening assays. By employing disease-specific antigens, up to 18 different autoantibodies can be differentiated on a single strip.

This state-of-the-art autoimmune diagnostic tool is produced by spotting antigens in lines on a nitrocellulose membrane utilizing the newest technologies available in the market, including HUMAN’s patented epitope-preserving technology.

Bound autoantibodies are visualized by using specific HRP-conjugated secondary antibodies that specifically target human antibodies and a LIA specific substrate. Samples positive for autoantibodies can be easily detected by comparing the pattern to the standardized cut-off line that is also spotted on the LIAs.

LIAs are ideal autoimmune diagnostic tools for screening and differential diagnosis as well as monitoring autoimmune patients by identifying specific autoantibodies in one assay.

ELISA Technology

The HUMAN ELISAs for Autoimmune DX offer a unique solution for all sizes of laboratories from low to high throughput. The ELISA line consists of around 60 ELISAs (both qualitative and quantitative) for the differential diagnosis of autoimmune diseases.

To provide the best solution for the requirements of each laboratory, HUMAN offers screening ELISAs for the detection of different subtypes (IgG, IgM, IgA) in one assay and single-parameter ELISAs for separate autoantigens.

The quantitative ELISAs are ideally suited for the monitoring of disease progression.

All ELISAs are optimized for automation and most are validated for use with HUMAN’s automated ELISA instruments: Elisys Uno, Elisys Duo and Elisys Quattro. Handling is as simple as can be thanks to ready-to-use reagents, breakable microtiter wells and reagents largely interchangeable between different assays and lots. The incubation conditions are the same for almost all assays.

Rapid Screening Technology

HUMAN’s autoimmune rapid screening tests use latex beads coated with disease relevant and specific antigens. In the presence of autoantibodies in patient serum, the latex beads agglutinate and provide results in less than 2 minutes. Rapid tests for screening are ideal for identifying potential autoimmune patients with rheumatic diseases quickly and easily.