85048, 85096 – Triple IFA

Highlights

• Uses tissue sections of rat liver, stomach, and kidney for accurate antigen presentation
• Detects multiple autoantibodies in a single assay: ANA, AMA, ASMA, and APCA
• Qualitative and semi-quantitative detection of IgG antibodies in human serum
• Aids in the diagnosis of autoimmune diseases affecting liver, stomach, and systemic tissues
• Provides distinct fluorescence patterns for precise identification of antibody types
• Supports differential diagnosis, disease monitoring, and treatment evaluation
• Designed for professional in vitro diagnostic use
• CE-marked

Intended Use

The Triple IFA is an immunofluorescence assay (IFA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum (ANA/AMA/ASMA/APCA) on tissue sections of rat liver, stomach and kidney. The Triple IFA is intended as an aid in the diagnosis of autoimmune diseases in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The appearance of autoantibodies directed against components of the cell nucleus is a hallmark of systemic autoimmune diseases, particularly systemic lupus erythematosus (SLE), Sjögren’s syndrome, progressive systemic sclerosis (PSS), mixed connective tissue disease (MCTD), rheumatoid arthritis (RA), and dermatomyositis. These antibodies interfere with normal cellular and humoral immune responses, which are typically directed against external threats, and under certain circumstances, they can turn against the body itself, causing autoimmune disorders.

Anti-Mitochondrial Antibodies (AMA)

AMA primarily target the inner mitochondrial membrane, which is rich in phospholipids. Clinicians most frequently find AMA in patients with primary biliary cirrhosis, pseudo-lupus-erythematosus-syndrome, and various forms of chronic aggressive hepatitis. Patients with non-suppurating gallbladder infections or primary biliary cirrhosis often show high AMA titres before clinical symptoms appear, and therapy rarely affects these antibody levels during disease progression. Lower AMA titres appear in scleroderma, Sjögren syndrome, rheumatoid arthritis, and other autoimmune disorders.

Anti-Smooth Muscle Antibodies (ASMA)

Antibodies against smooth, unstriated muscle are present in several liver conditions, including acute and chronic hepatitis, primary biliary cirrhosis, and other forms of liver cirrhosis. ASMA detection also aids in diagnosing SLE, breast and ovarian carcinoma, infectious mononucleosis, and malignant melanomas.

Parietal Cell Antibodies (PCA)

Pernicious anaemia typically involves circulating antibodies against parietal cell structures in the gastric mucosa. Clinicians also detect PCA in chronic atrophic gastritis, gastric ulcers, thyroid disorders such as Hashimoto’s thyroiditis or myxoedema, and, more rarely, in hypoferric anaemia, diabetes mellitus, and older patients.