4099 – HepAK 7plus Dot

Intended Purpose

The HepAK 7plus 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 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 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).

Product Specifications

Title HepAK 7plus Dot
Product code 4099
Indication Autoimmune liver disease
Description Dot Immunoassay for the qualitative determination of IgG antibodies against M2, gp210, sp100, LKM1, LC1, SLA and F-actin in human serum
Format Test strips coated with M2, gp210, sp100, LKM1, LC1, SLA and F-actin
Total incubation time 80 min.
Sample volume 10 µL serum
No. of determinations 24 x 7

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