Intended Use
The ELISA test kit provides a qualitative or semiquantitative in vitro assay for human autoantibodies of the immunoglobulin class IgG against antigens of the glomerular basement membrane (GBM antigens) in serum or plasma.
Contents of Kit
1. Microplate wells coated with antigens: 12 microplate strips each containing 8 individual break-off wells in a frame, ready for use. 12 × 8
2. Calibrator 1: 200 RU/ml (IgG, human), ready for use. 1 × 2.0 ml
3. Calibrator 2: 20 RU/ml (IgG, human), ready for use. 1 × 2.0 ml
4. Calibrator 3: 2 RU/ml (IgG, human), ready for use. 1 × 2.0 ml
5. Positive control: (IgG, human), ready for use. 1 × 2.0 ml
6. Negative control: (IgG, human), ready for use. 1 × 2.0 ml
7. Enzyme conjugate: peroxidase-labelled anti-human IgG (rabbit), ready for use. 1 × 12 ml
8. Sample buffer: ready for use. 1 × 100 ml.
9. Wash buffer 10× concentrate: 1 × 100 ml
10. Chromogen/substrate solution: TMB/H2O2, ready for use colourless 1 × 12 ml
11. Stop solution: 0.5 M sulphuric acid, ready for use colourless 1 × 12 ml
12. Test instruction
13. Quality control certificate
Storage
The test kit has to be stored at a temperature between +2°C to +8°C. Do not freeze. Unopened, all test kit components are stable until the indicated expiry date.
Detection Range
The levels of the anti-GBM antibodies (IgG) were analyzed with this ELISA in a panel of 350 healthy blood donors. With a cut-off of 20 RU/ml, all blood donors were anti-GBM negative.
Detection Limit
The lower detection limit is defined as the mean value of an analyte-free sample plus three times the standard deviation and is the smallest detectable antibody titer. The lower detection limit of the Anti-GBM ELISA (IgG) is 1.6 RU/ml.
General Description
The detection of circulating autoantibodies against glomerular basement membrane (GBM) is an important contribution to the diagnosis of anti-GBM disease, a progressive glomerulonephritis that often involves the lungs (then called Goodpasture syndrome). In addition to securing a diagnosis, the anti-GBM ELISA (IgG) is used for therapy monitoring. High autoantibody titers indicate an unfavourable development.
Citations
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