5021 – DotDiver HepAK 7 plus

Intended Purpose

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. The DotDiver HepAK 7 plus is intended as an aid in the diagnosis of autoimmune liver diseases disease 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 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 DotDiver HepAK 7 plus
Product code 5021
Indication Autoimmune liver diseases
Description Dot immunoassay for the qualitative determination of IgG antibodies against liver specific antigens in human serum
Format Test strips coated with highly purified M2, gp210, sp100, LKM1, LC1, SLA and F-actin
Total incubation time 64 min.
Sample volume 10 µL serum
No. of determinations 24 x 7

Free downloads

  SDS [REF 5021][eng]   SDS [REF 5021][deu]

Restricted downloads - Password required

Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.