Intended use:

For in vitro diagnostic use. The RIDASCREEN® Mycoplasma pneumoniae tests are enzyme immunoassays for the quantitative determination of IgA, IgG or IgM antibodies against Mycoplasma (M.) pneumoniae in human serum. The tests should be used for confirmation purposes when there is a suspected case of infection with Mycoplasma pneumoniae or for clarifying the immune status.

General information:

The incubation period of an infection with M. pneumoniae takes a relatively long time and lasts from 10 days to three weeks. After the clinical symptoms have subsided, M. pneumoniae can be excreted for weeks. However, the infectivity of the causative agent is very slight, so that close contact must exist for transmission to take place, such as given in families, day care centers, schools and military facilities. First contact with the causative agent does not produce immunity.

The clinical picture of a M. pneumoniae infection is that of a tracheobronchitis with lethargy, fever, headache and persistent, initially unproductive coughing. In approx. 10% of all cases, atypical, interstitial pneumonia develops. In addition, a multitude of extrapulmonal complications can be found like in other bacterial and viral infections and which are not M. pneumoniae specific. A differential diagnostical clarificaton is, therefore, very important. The RIDASCREEN® Mycoplasma pneumoniae tests are, as an enzyme immunoassay, a simple and highly sensitive method for the detection of antibodies against M. pneumoniae.

Test principle:

Purified antigens are coated to a microwell plate. Antibodies in the patient samples bind to the antigens and are determined during the second incubation step by using enzyme-labelled anti-human antibodies (the conjugate). The enzyme converts the colourless substrate (H2O2/TMB) to a blue end product. The enzyme reaction is stopped by adding sulphuric acid and the colour of the mixture switches from blue to yellow at the same time. The final measurement is carried out at 450 nm on a photometer using a reference wavelength ≥ 620 nm.

Art. No. K43**
Test format Article no. K4321
Mycoplasma pneumoniae IgG (96 determinations)

Article no. K4331
Mycoplasma pneumoniae IgM (96 determinations)

Microtiter plate with 96 wells (12 strips with 8 wells each; strips can be divided into single wells)
Incubation time 3 x 30 min at 37 ºC
Sensitivity 95,8% (IgA)
95.0% (IgG)
100.0% (IgM)
Specificity 95,2% (IgA)
100.0% (IgG)
97.9% (IgM)
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