Mycoplasma pneumoniae IgG ELISA Kit

Sample

Human serum or EDTA, heparin or citrate plasma.

Species Reactivity

Human

Detection Method

iELISA

Intended Use

The ELISA test kit provides a semiquantitative or quantitative in vitro assay for human antibodies of the immunoglobulin class IgG against Mycoplasma pneumoniae in serum or plasma.

Contents of Kit

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 international reference serum exists for antibodies against Mycoplasma pneumoniae, the calibration is performed in relative units (RU). For every group of tests performed, the extinction values of the calibrators and the relative units and/or 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 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 (+18°C to +25°C) 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 antigen is a detergent extract of Mycoplasma pneumoniae, strain MAC ATCC 15531. The extract was further purified to prevent cross reactivity.

Detection Limit

The lower detection limit is defined as mean value of an analyte-free sample plus three times the standard deviation and is the smallest detectable antibody titer. The detection limit of the Mycoplasma pneumoniae IgG ELISA Kit is 1 RU/ml.