ED-GP114

Intended use
The Wieslab® anti-GBM screening kit is an ELISA for qualitative analysis of anti-glomerular basement membrane (GBM) antibodies. The test is useful as an aid in screening for reno-pulmonary syndromes and rapidly progressive glomerulonephritis, such as Goodpasture syndrome.
Six patient''s samples can be tested on twelve occasions The test is completed within 40 minutes.
A positive result should always be confirmed by a quantitative assay.
For research and in-vitro diagnostic use only.

Principle of the Wieslab® anti-GBM sreening assay
The wells of a microtiterstrip 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 spectrophotometrically in terms of absorbance.

Kit components and storage of reagents
- Frame with lid and strips (12x8 wells) coated with GBM, sealed in a foilpack with a dry pack.
- Negative control containing human serum.
- Positive control containing human serum.
- Conjugate containing alkaline phosphatase-labeled antibodies to human IgG in specially made PBS with protein stabilizer.
- Diluent containing specially made PBS.
- Substrate solution containing diethanolamine with Mg2+.
- Substrate tablets containing p-nitrophenyl phosphate.
- Instructions for the preparation of the washing solution.

All reagents in the kit are ready for use and should be stored at + 2-8 C.