ED-GP104X

Intended use
The Wieslab® anti-GBM is an ELISA kit for semi-quantitative analysis of anti-GBM antibodies (GBM = glomerular basement membrane). The test is useful as an aid in the diagnosis of autoimmune renal disorders such as Goodpasture syndrome.
40 patient samples can be tested in duplicate. The test is completed within two hours.
For research and in-vitro diagnostic use only.

Principle of the Wieslab® anti-GBM assay
The wells of the microtiter strips are coated with purified Goodpasture antigen. 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-labeled 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 color 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 Goodpasture antigen, 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 stabilizer.
- 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.