4099 – HepAK 7^plus Dot

Intended Purpose

The HepAK 7^plus Dot 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 7^plus 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 disease (PAL), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC), just like other forms of chronic liver diseases, show autoimmune pathogenesis, the appearance of autoantibodies. This pathogenesis thus points out the need for specific autoantibody determination after the exclusion of infectious etiology e.g. viruses. PSC show intestine related symptoms with ANCA patterns serological diagnosis (e.g. via indirect immunofluorescence) on neutrophils. The occurrence of antibodies to mitochondrial antigens (M2) is typical of PBC. AIH show different autoantibodies, especially autoantibodies to; antinuclear antibodies (ANA), smooth muscles (ASMA), liver and kidney microsomal antigens (LKM),  the soluble liver antigen (SLA).