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 x 8 .STRIPS.
2. Calibrator (IgA, human), ready for use, dark red, 1 x 2.0 ml .CAL.
3. Positive control (IgA, human), ready for use, blue, 1 x 2.0 ml .POS CONTROL.
4. Negative control (IgA, human), ready for use, green 1 x 2.0 ml .NEG CONTROL.
5. Enzyme conjugate, peroxidase-labelled anti-human IgA (rabbit), ready for use, orange, 1 x 12 ml .CONJUGATE.
6. Sample buffer, ready for use, light blue, 1 x 100 ml .SAMPLE BUFFER.
7. Wash buffer, 10x concentrate, colourless, 1 x 100 ml .WASH BUFFER 10x.
8. Chromogen/substrate solution, TMB/H2O2, ready for use, colourless, 1 x 12 ml .SUBSTRATE.
9. Stop solution, 0.5 M sulphuric acid, ready for use, colourless, 1 x 12 ml .STOP SOLUTION.
10. Test instruction --- 1 booklet
11. Quality control certificate --- 1 protocol
Performance Characteristics
Calibration: As no international reference serum exists for antibodies against influenza A viruses, results are provided in the form of ratios which are a relative measure for the concentration of antibodies.
For every group of tests performed, the extinction values of the calibrator and the ratios of 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 activity of the enzyme used is temperature-dependent and the extinction values may vary if a thermostat is not used. The higher the room temperature during substrate incubation, 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 antigen source is provided by inactivated allantois fluid of chicken embryos infected with the "Texas" (H3N2) strain of Influenza A virus, „Singapore" (H1N1) strain of Influenza A virus and "California" (H1N1, Porcine Influenza).