5021 – DotDiver HepAK 7 plus

Highlights

• Detection of IgG autoantibodies against liver-specific antigens (M2, gp210, sp100, LKM1, LC1, SLA, F-actin)
• Supports the diagnosis of autoimmune liver diseases (AIH, PBC, PSC) in conjunction with clinical and laboratory findings.
• Enables assessment of primary biliary cirrhosis (PBC) progression via gp210 and sp100 antibodies, linked to risk of hepatic failure or liver transplantation.
• Uses dot immunoassay principle with antigen-coated test strips and colorimetric detection for quantitative antibody activity.
• Ready-to-use test strips and cartridges for consistent, reproducible results
• Suitable for routine laboratory testing
• CE marked

Intended Use

The DotDiver HepAK 7 plus is a qualitative dot immunoassay for the determination of IgG antibodies against liver-specific antigens (M2, gp210, sp100, LKM1, LC1, SLA, and F-actin) in human serum. It is intended as an aid in the diagnosis of autoimmune liver diseases, including autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and primary sclerosing cholangitis (PSC), in conjunction with other clinical and laboratory findings.. The immunoassay is designed for semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.

Diagnostic Relevance

Primary autoimmune liver diseases (PAL) feature IgG autoantibodies targeting specific liver antigens.  Autoimmune hepatitis (AIH) often presents with antinuclear antibodies (ANA), anti-smooth muscle antibodies (ASMA) targeting F-actin, liver-kidney microsomal antibodies (LKM1), LC1 antibodies, and soluble liver antigen (SLA) antibodies. Primary biliary cirrhosis (PBC) typically involves anti-mitochondrial M2 antibodies and disease-specific antinuclear antibodies against gp210 and sp100. Primary sclerosing cholangitis (PSC) may show atypical ANCA patterns detected by indirect immunofluorescence on neutrophils.

The detection of these IgG autoantibodies is essential for differentiating autoimmune liver diseases from other hepatic conditions, enables earlier intervention, and facilitates monitoring of treatment response. The DotDiver HepAK 7 plus provides a reliable, semi-automated method for comprehensive antibody profiling, improving diagnostic confidence in routine laboratory practice.