Humanized Control Antibodies

Introduction

Autoimmune diseases result from an overactive immune system attacking self-tissues and organs, leading to a variety of disorders. The development of autoimmune diseases is influenced by multiple factors, including genetic mutations, environmental triggers, and immune system dysregulation. Some genetic variants increase the risk of autoimmune conditions, while external factors such as infections, drugs, and psychological stress can also contribute to disease onset.

In most autoimmune diseases, autoantibodies are present in the patient’s serum at significantly elevated levels. Detecting these autoantibodies plays a crucial role in disease diagnosis and monitoring. As the understanding of autoantibodies advances, their clinical applications in diagnostics and prognostic evaluations continue to expand, making autoantibody detection a vital component of autoimmune disease research and clinical assessment.

Fig. 1 Representative organ-specific and systemic autoimmune diseases

Coverage and Target Areas

Creative Diagnostics has developed over 100 humanized quality control antibodies covering multiple autoimmune disease biomarkers. The details are as follows:

• Antinuclear Antibodies (ANAs)

ANAs are a group of autoantibodies produced against DNA, RNA, proteins or complexes of these substances in nuclear cells, including autoantibodies against Sm, dsDNA, nucleosomes, histones, P0, PCNA, SSA, Ro52, SSB/La, Scl-70, Jo-1, PM/Scl, CENP-B, nRNP/Sm, AMA-M2 and other targets.

When ANAs increase, it may indicate diseases such as systemic lupus erythematosus, mixed connective tissue disease, scleroderma, rheumatoid arthritis, Sjögren's syndrome, and drug-induced lupus.

• Anti-neutrophilcytoplastic Antibodies (ANCAs)

ANCAs refers to antibodies that react with the cytoplasm of neutrophils and monocytes. When neutrophils are stimulated by antigens, the cytoplasm releases proteinase-3 (PR3), myeloperoxidase (MPO), etc., which stimulate the body to produce ANCA.

Anti-PR3 antibody is a hallmark antibody of Wegener's granulomatosis (WG). Anti-MPO antibody positivity is highly correlated with necrotizing vasculitis or idiopathic glomerulonephritis.

• Anti-Smooth Muscle Antibody (ASMA)

ASMA refers to an autoantibody against the body's smooth muscle tissue. It is non-organ and species-specific and mainly of IgG and IgM types. It can be detected in patients with autoimmune liver disease, infectious mononucleosis, etc.

• Autoimmune Thyroid Disease

Autoimmune thyroid disease is closely related to thyroid autoantibodies, which are antibodies against certain components of the thyroid gland due to autoimmune disorders. They are mainly divided into two categories: antibodies against TSHR on the surface of thyroid cells, namely TRAbs; antibodies against the contents of thyroid cells, including thyroid peroxidase antibodies (TPOAbs) and thyroglobulin antibodies (TGAbs).

• Type 1 Diabetes

Type 1 diabetes is an autoimmune disease that involves the presence of antibodies that attack the body's own cells, such as islet cell antibodies (ICA), insulin antibodies (IAA), glutamic acid decarboxylase antibodies (GADA), protein tyrosine phosphatase-like protein antibodies (IA-2A and IA-2BA), zinc transporter 8 antibodies (ZnT-8A), etc.

• Rheumatoid Arthritis (RA)

Rheumatoid factor (RF) is the first important indicator discovered for diagnosing RA, produced by human B cells. Anti-cyclic citrullinated peptide (CCP) antibodies are highly specific indicators for early diagnosis of RA. Anti-mutated citrullinated vimentin (MCV) antibodies can be used for auxiliary diagnosis of RA.

• Antiphospholipid Syndrome

The representative variety is anti-cardiolipin antibody (ACA), which can interfere with the phospholipid-dependent coagulation process and inhibit the release of prostacyclin by endothelial cells. It is closely related to thrombosis, cardiovascular and cerebrovascular ischemic diseases, and changes in the coagulation system. ACA positivity is common in rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), spontaneous abortion, Sjögren's syndrome and other diseases.

• Antisynthetase Antibody Syndrome

The presence of antibodies to aminoacyl-tRNA synthetase, an enzyme that attaches specific amino acids to the corresponding tRNA, can lead to the recruitment of antigen-presenting cells and inflammatory cells to the muscles or lungs, resulting in anti-synthetase antibody syndrome. Among the 11 known aminoacyl-tRNA synthetase antibodies, Jo-1 antibody is the most commonly detected, while other types are less common.

• Autoimmune Infertility and Miscarriage

The main testing items included in this series are: anti-ovarian antibodies, anti-endometrial antibodies, anti-sperm antibodies, anti-human chorionic gonadotropin antibodies, anti-zona pellucida antibodies, anti-trophoblast antibodies, etc.

• Autoimmune Liver Disease

Autoimmune liver disease is a special type of chronic liver disease caused by immune dysfunction in the body, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis and the so-called overlap syndrome. The main targets involved are LKM-1, gp210, sp100, LC-1, SLA/LP, etc.

• Autoimmune Nephropathy

Autoimmune nephropathy-related antibodies mainly include anti-glomerular basement membrane (GBM) antibodies and anti-phospholipase A2 receptor (PLA2R) antibodies.

• Autoimmune Gastritis

Autoimmune gastritis is a chronic inflammation of the gastric fundus and body caused by anti-parietal cell antibodies and anti-intrinsic factor antibodies that attack the gastric mucosa, and may cause symptoms such as anemia.

• Autoimmune Myositis

Autoimmune myositis is a type of autoimmune disease with a relatively small number of patients. HMGCR, MDA5, and TIF1-γ/TRIM33 antibodies are highly specific diagnostic indicators.

• Autoimmune Neurological Disease

There are many targets associated with autoimmune neurological diseases. For example, gangliosides are glycosphingolipids containing at least one sialic acid linked to a carbohydrate moiety. They are widely present in all cells and body fluids and are most abundant in the nervous system.

• Autoimmune Hematological Disease

The antibody associated with autoimmune hematological disease is mainly platelet factor 4 (PF4) antibody.

• Celiac Disease

Celiac disease is a hereditary autoimmune disease. After patients ingest gluten, the small intestinal mucosa is damaged, leading to nutrient absorption disorders and a variety of clinical manifestations. Serum tissue transglutaminase (tTG) IgA antibodies are important markers of celiac disease.

• Bullous Skin Disease

Bullous dermatosis is an organ-specific autoimmune disease. The patient's serum contains autoantibodies against the skin's connecting structure, which can destroy the skin's adhesion function and lead to blisters and erosions on the skin and mucous membranes. The main related targets are BP180, DSG1, and DSG3.

• Systemic Sclerosis

Systemic sclerosis is an autoimmune disease characterized by microangiopathy, extensive fibrosis, and multiple autoantibodies. POLR3K and fibrillarin are common targets of systemic sclerosis-related autoantibodies.