5070 – DotDiver HepAK 10
The DotDiver HepAK 10 is a qualitative dot immunoassay for the determination of IgG antibodies against liver specific antigens (M2/nPDC, M2/OGDC-E2, M2/BCOADC-E2, M2/PDC-E2, gp210, sp100, LKM1, LC1, SLA and F-actin) in human serum. The DotDiver HepAK 10 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 semi-automated use with the DotDiver instrument. The immunoassay is designed for professional in vitro diagnostic use.
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).
|Title||DotDiver HepAK 10|
|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/nPDC, M2/OGDC-E2, M2/BCOADC-E2, M2/PDC-E2, gp210, sp100, LKM1, LC1, SLA and F-actin|
|Total incubation time||64 min.|
|Sample volume||10 µL serum|
|No. of determinations||24 x 10|