4099 – HepAK 7^plus Dot

Highlights

• Use of highly purified antigens (M2, gp210, sp100, LKM1, LC1, SLA, F-actin) for solid-phase detection
• Qualitative dot immunoassay for simultaneous detection of multiple IgG autoantibodies in human serum
• Supports the diagnosis of autoimmune liver diseases, including AIH, PBC, and PSC
• Ready-to-use test strips, sample diluent, conjugate, and substrate for efficient workflow
• zyme-based detection with clear, insoluble colored signal for semi-quantitative interpretation
• Reliable and reproducible results for routine laboratory testing
• Suitable for monitoring disease progression and extra-articular manifestations
• Manual, professional in vitro diagnostic use
• CE marked

Intended Use

The HepAK 7^plus  is a qualitative dot immunoassay for the determination of IgG antibodies against M2, gp210, sp100, LKM1, LC1, SLA, and F-actin in human serum. The HepAK 7plus Dot is intended as an aid in the diagnosis of autoimmune liver diseases, in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Primary autoimmune liver diseases (PAL), including autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC), as well as other forms of chronic liver disease, are characterized by autoimmune pathogenesis with the presence of disease-specific autoantibodies. Accurate serological testing is essential, especially after excluding infectious causes such as viral hepatitis.

Primary biliary cirrhosis (PBC) typically shows autoantibodies to mitochondrial antigens (M2). Autoimmune hepatitis (AIH) often presents with diverse autoantibodies, including antinuclear antibodies (ANA), anti-smooth muscle antibodies (ASMA), liver–kidney microsomal antibodies (LKM1 and LC1), and antibodies against the soluble liver antigen (SLA). Primary sclerosing cholangitis (PSC) frequently involves gastrointestinal manifestations and exhibits characteristic ANCA patterns detectable by indirect immunofluorescence on neutrophils.

By enabling the simultaneous detection of multiple autoantibodies, the HepAK 7plus Dot supports early and precise diagnosis, facilitates differentiation between autoimmune liver disorders, and aids in guiding patient management and monitoring disease progression.