4030 – HepAK^plus Dot

Highlights

• Use of highly purified and recombinant liver-specific antigens (M2, LKM1, LC1, SLA, and F-actin)
• Simultaneous qualitative detection of multiple IgG autoantibodies on a single test strip
• Supports serological differentiation of autoimmune liver diseases, including AIH, PBC, and PSC
• Enables antibody profiling for AIH subtypes I, II, and III
• Clear visual interpretation with optional documentation using an interpretation template
• Manual dot immunoassay for professional in vitro diagnostic use
• CE marked

Intended Use

The HepAK^plus Dot is a qualitative dot immunoassay for the determination of IgG antibodies against M2, LKM1, LC1, SLA, and F-actin in human serum. The assay provides simultaneous detection of multiple liver-specific autoantibodies on a single test strip, enabling comprehensive serological profiling. The HepAK^plus Dot is intended as an aid in the diagnosis and differentiation of autoimmune liver diseases when used in conjunction with clinical findings and additional laboratory investigations. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Primary autoimmune liver diseases, including autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC), represent a significant subset of chronic liver disorders with an autoimmune pathogenesis. These diseases feature disease-specific autoantibodies that play a central role in diagnosis and classification. After exclusion of infectious causes, particularly viral hepatitis, targeted autoantibody testing is essential for establishing the correct diagnosis.

Primary biliary cirrhosis (PBC) shows a strong serological association with antimitochondrial antibodies, and M2 antibodies provide the highest diagnostic specificity. In contrast, primary sclerosing cholangitis (PSC) often presents with intestinal manifestations, and clinicians frequently observe atypical ANCA patterns by indirect immunofluorescence on neutrophils.

Autoimmune hepatitis exhibits a heterogeneous autoantibody profile, which enables further subclassification of the disease. Type I AIH commonly shows antinuclear antibodies (ANA) and anti-smooth muscle antibodies (ASMA), which recognize polymeric F-actin structures. Type II AIH is associated with antibodies against liver and kidney microsomal antigen 1 (LKM1) and liver cytosol antigen 1 (LC1). Antibodies to soluble liver antigen (SLA) are considered highly specific and may indicate a more severe disease course. The simultaneous detection of these antibodies supports accurate diagnosis, disease stratification, and clinical decision-making in patients with suspected autoimmune liver disease.