RIDASCREEN® Mycoplasma pneumoniae IgA
Product Code K4311
Intended use:
For in vitro diagnostic use. The RIDASCREEN® M. pneumoniae IgA test is an enzyme immunoassay (EIA) for the semi-quantitative determination of IgA antibodies against Mycoplasma (M.) pneumoniae in human serum. The test 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 test
is, as an enzyme immunoassay, a simple and highly sensitive method for
the detection of antibodies against M. pneumoniae. In contrast to other
immunological procedures such as the CFT, a differentiation of the
different immunoglobulin classes is possible with the EIA.
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.
Specifications:
Format: | 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% |
Specificity: | 95.2% |