Intended Use
The Anti-West Nile Virus ELISA (IgM) test kit provides a semiquantitative assay for human antibodies of the IgM class against West Nile virus in serum or plasma.
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.
Performance Characteristics
Calibration: As no quantificated international reference serum exists for antibodies of the IgM class against West Nile virus, 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 calibrators and the ratios 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 control sera 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 a recombinant, detergent-extracted glycoprotein E of WNV from the membrane fraction of human cells.
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-West Nile ELISA (IgM) is a ratio value of 0.03.
Citations
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