ED-ASCA151

Intended use
The Wieslab® ASCA test is an enzyme-linked immunosorbent assay (ELISA) for semi-quantitative/or qualitative detection of IgA autoantibodies against the mannan structure of Saccharomyces cerevisiae in human sera. Tha assay is used to detect antibodies in a single serum specimen. The results of the assay are useful as an aid in the diagnosis of Crohn''s disease and also in its differentiation from Ulcerative colitis.
40 patient samples can be tested in duplicate quantitatively or 45 patient samples qualitatively. The test is completed within two hours.
For research and in-vitro diagnostic use only.

Principle of the Wieslab® ASCA assay
The wells of the microtiter strips are coated with purified mannan derived from S. cerevisiae. During the first incubation, specific antibodies in diluted serum or plasma, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components.
A conjugate of alkaline phosphatase-labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance. The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.

Kit components and storage of reagents
- Frame with lid and strips (12x8) coated with mannan, sealed in a foil pack with a dry pack.
- Negative control containing human serum.
- Positive control containing human serum.
- Five calibrators containing human serum.
- Conjugate containing alkaline phosphatase-labelled antibodies to human IgG in PBS with protein stabiliser.
- Diluent containing specially made PBS.
- Substrate solution containing diethanolamine with Mg2+ as an enzyme cofactor.
- Substrate tablets containing p-nitrophenyl phosphate.
- Instructions for the preparation of wash solution.
All reagents in the kit are ready for use and should be stored at + 2-8 C.