4030 – HepAKplus Dot

Intended Purpose

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. 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 HepAKplus Dot
Product code 4030
Indication Autoimmune liver disease
Description Dot Immunoassay for the qualitative determination of IgG antibodies against M2, LKM1, LC1, SLA and F-actin in human serum
Format Test strips coated with M2, LKM1, LC1, SLA and F-actin
Total incubation time 80 min.
Sample volume 10 µL serum
No. of determinations 24 x 5

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  SDS [REF 4030][ENG]   SDS [REF 4030][DEU]

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