Intended use:
The SeraSpot® HepAk-7 IgG test is an in vitro diagnostic device for the detection of autoantibodies of the IgG isotype of the following antigens: AMA-M2, LKM1, LC1, SLA, F-Aktin, gp210 and Sp100 in human serum or plasma.
General information:
Primary autoimmune liver disease (PAL) can be subdivided into autoimmune hepatitis (AIH) type I to III, primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). Beside these clearly defined diseases, variant forms described as overlap syndrome additionally exist. These forms include characteristics of AIH and PBC or PSC. Clinical symptoms of PAL resemble that of other chronic liver diseases. The progress of chronic liver diseases may result in the development of liver cirrhosis. Only an early diagnosis and treatment may prevent such an outcome. In early stages liver diseases are characterized by increased levels of serum transaminases. Unspecific symptoms as sickness, fatigue and arthralgia can additionally occur. About 15 % of chronic liver disease cases underlie an autoimmune pathogenesis. Therefore the determination of different autoantibodies is recommended after exclusion of a virus hepatitis. The early therapy as a result of a correct diagnosis correlates with a positive prognosis.
The SeraSpot® HepAk-7 IgG test enables the fast determination of autoantibodies with diagnostic relevance for autoimmune liver diseases.
Test principle:
The SeraSpot® HepAk-7 IgG is a solid phase immunoassay based on the use of recombinant or purified native proteins / protein complexes as capture antigens printed in array arrangement (spot array) on the bottom of the wells of 96-well microtiter plates. The antigens serve as capture molecules for autoantibodies, which are formed in autoimmune liver diseases. Bound antibodies are detected by horseradish peroxidase-(HRP)-labeled antibodies against human antibodies of IgG-type by substrate reaction with hydrogen peroxide and 3,3’,5,5’-tetramethylbenzidine (TMB). At the site of formed immune complexes blue spots are developed by precipitated product from colorless substrate solution. Color intensity is correlated to the antibody concentration. Pale blue to dark blue spots are visible by eye.
Art. No.:
- SP-004-7 G-S6 (1×48)
| Art. No. | SP-004-7 G-S6 |
|---|---|
| Test format | Microspot array |
| Incubation time | 1.5 h |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.
