Autoimmune Diseases

Autoimmunity involves the loss of normal immune homeostasis such that the organism produces an abnormal response to its own self tissue. Our bodies have an immune system, which is a complex network of special cells and organs that defends the body from germs and other foreign invaders. At the core of the immune system is the ability to tell the difference between self and non-self. A flaw can make the body unable to tell the difference between self and non-self. When this happens, the body makes autoantibodies that attack normal cells by mistake. At the same time, special cells called regulatory T cells fail to do their job of keeping the immune system in line. The result is a misguided attack on your own body, leading to autoimmune diseases. The body parts that are affected depend on the type of autoimmune disease. Nearly any body part can be involved, like the heart, brain, nerves, muscles, skin, eyes, joints, lungs, kidneys, glands, the digestive tract, and blood vessels.

Diagnosis of Autoimmune Diseases


When evaluating a patient with suspected autoimmune disease, a combination of laboratory tests and a review of symptoms and physical examinations are often used. Multiple laboratory tests are needed and applied to establish a diagnosis. These tests can be useful in the diagnosis, prognosis, and severity evaluation of an autoimmune disease. Often, they are divided into the following types:

  • Hematologic tests for measurement of platelet count and/or white blood cell count, enzymes, and metabolites
  • Inflammatory marker tests for measurement of C-reactive protein, ferritin, ceruloplasmin, fibrinogen, etc.
  • Autoantibody tests for measurement of rheumatoid factor, anti-cyclic citrullinated peptide antibody, anti-nuclear antibody, etc.

Diagnostic Biomarkers of Autoimmune Diseases

Autoantibodies are the most commonly used diagnostic biomarkers of autoimmune diseases. Their presence and levels can be indicative of not only a disease itself but also a patient's risk of progressing to clinical onset of an autoimmune disease. They can be either directly pathogenic (e.g., anti-GBM antibody) or disease-associated. They can be valuable as prognostic markers (e.g., anti-AMA-M2 antibody), helpful in patient monitoring (e.g., anti-dsDNA antibody) or necessary for differential diagnosis (e.g., anti-Mi2 antibody). With the development of technologies, more and more novel potential biomarkers have been identified to increase the specificity of in vitro diagnostics (IVDs). These include the discovery of protein-based biomarkers and serum microRNAs. Moreover, the combination of existing markers into a multi-marker panel has been proposed as a powerful strategy to improve sensitivity and specificity.

The Use of IVD Immunoassays for Biomarker Detection

Different IVD techniques have been developed for the detection or quantification of different types of autoimmune disease biomarkers. The quantification of autoantibodies, for example, is principally done with enzyme immunosorbent assays (EIAs). The antigens are fixed on the microwell plates for detection of the autoantibodies in patient serum. For protein-based biomarkers, IVD antibodies and antibody-based assays can be developed to quantitively measure their levels.

IVD Antibody & Kit Development Services Provided by Creative Biolabs

Creative Biolabs provides one-stop IVD antibody development and diagnostic immunoassay development services to global clients. We offer specialized expertise ranging from antigen design, protein production, and antibody development to assay feasibility analysis, assay design, assay protocol establishment, validation, and kit production. For more information please click the links below:

Autoimmune Diseases

We focus on different types of autoimmune diseases and a wide spectrum of diagnostic biomarkers as follows:

Features of Our Services

  • Our repertoire includes both established and novel biomarkers
  • A specialized technical team and abundant experience in antibody/immunoassay development
  • State-of-the-art techniques and short turnaround time
  • Services are tailored to meet the needs of our valued IVD clients.

Please feel free to contact us for more information and a formal quote.


  1. Castro, C., (2010). “Diagnostic testing and interpretation of tests for autoimmunity.” Journal of Allergy and Clinical Immunology. 125(2), S238-S247.

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