Intended Use
The anti-β2-Glycoprotein 1 (IgM) ELISA Kit is used to detect Anti-phospholipid syndrome.
Contents of Kit
1. Microplate wells, Coated with antigens: 12 microplate strips each containing 8 individual breakoff wells in a frame, ready for use --- 12 x 8. STRIPS.
2. Calibrator 1 200 RU/ml (IgG, human), ready for use Dark red 1 x 2.0 ml. CAL 1.
3. Calibrator 2 20 RU/ml (IgG, human), ready for use Red 1 x 2.0 ml. CAL 2.
4. Calibrator 3 2 RU/ml (IgG, human), ready for use Light red 1 x 2.0 ml. CAL 3.
5. Positive control (IgG, human), ready for use Blue 1 x 2.0 ml. POS CONTROL.
6. Negative control (IgG, human), ready for use Green 1 x 2.0 ml. NEG CONTROL.
7. Enzyme conjugate Peroxidase-labelled anti-human IgG (rabbit) Green 1 x 12 ml. CONJUGATE.
8. Sample buffer ready for use Light blue 1 x 100 ml. SAMPLE BUFFER.
9. Wash buffer 10x concentrate Colorless 1 x 100 ml. WASH BUFFER 10x.
10. Chromogen/substrate solution TMB/H2O2, ready for use Colorless 1 x 12 ml. SUBSTRATE.
11. Stop solution 0.5M sulfuric acid, ready for use Colorless 1 x 12 ml. STOP SOLUTION.
12. Test instruction --- 1 booklet
13. Quality control certificate --- 1 protocol
Storage
The test kit has to be stored at a temperature between +2°C to +8°C. The calibrators and positive control must be stored in aliquots at -20°C. Unopened, all test kit components are stable until the indicated expiry date.
Performance Characteristics
Calibration: As no international reference serum exists for the measurement of antibodies against β2-glycoprotein 1, the calibration is performed in relative units (RU)/ml.
For every group of tests performed, the extinction values of the calibrators and the relative units and/or ratio determined for the positive and negative controls must lie within the limits stated for the relevant test kit lot. A quality control certificate containing these reference values is included. If the values specified for the controls are not achieved, the test results may be inaccurate and the test should be repeated.
The binding activity of the antibodies and the activity of the enzyme used are temperature-dependent. It is therefore recommended using a thermostat in all three incubation steps. The higher the room temperature during the incubation steps, the greater will be the extinction values. Corresponding variations apply also to the incubation times. However, the calibrators are subject to the same influences, with the result that such variations will be largely compensated in the calculation of the result.
Antigen: The microplate wells were coated with highly purified β2-glycoprotein 1 isolated from human serum. The purity of the preparation was verified by SDS polyacrylamide gel electrophoresis (4% to 12% gel). The adjacent figure shows a molecular weight marker on track 1 of the electrophoresis, and the purified β2- GP1 applied to track 2. β2-GP1 has a molecular weight of 50 kDa, its function is not known. β2-GP1 is found in human plasma, both in the free state as well as associated with low-density lipoproteins.
Detection Limit
1.8 RU/ml
General Notes
The anti-β2-Glycoprotein 1 (IgM) ELISA Kit is used to detect Anti-phospholipid syndrome.
Citations
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