4030 – HepAKplus Dot

The HepAKplus Dot is a qualitative dot immunoassay for the determination of IgG antibodies against M2, LKM1, LC1, SLA and F-actin in human serum. The HepAKplus Dot is intended as an aid in the diagnosis of autoimmune liver diseases in conjunction with other clinical and laboratory findings.

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).

Dot immunoassays are frequently used for the determination of specific antibodies directed against multiple antigens. The test strips are coated with various antigens in consistent intervals. If antibodies are present in the patient´s sample, they bind to the respective antigens. A secondary antibody conjugated with the enzyme alkaline phosphatase detects the generated immune complexes. A colorless substrate is converted into a colored, insoluble product. The signal intensity of the precipitated reaction product is proportional to the antibody activity in the sample.

The HepAKplus Dot is designed for manual professional in vitro diagnostic use.