For in vitro diagnostic use. RIDA®GENE Mycoplasma pneumoniae is a multiplex real-time PCR for the direct, qualitative detection of Mycoplasma pneumoniae from human tracheal secretion, sputum and bronchoalveolar lavage fluid (BAL).
The RIDA®GENE Mycoplasma pneumoniae multiplex real-time PCR is intended for use as an aid in diagnosis of respiratory infections caused by Mycoplasma pneumoniae.
Community acquired pneumonia (CAP) is the most registererd infectious disease worldwide and in Western Nations it is the most fatal infectious disease. In Germany, there are yearly up to 800,000 cases of CAP and the mortality rate varies, dependent whether it is community acquired or hospital acquired, between 2 – 60%. Bacteria are the most common pathogen of CAP where one differentiates between typical and atypical pathogen. Atypical bacteria cannot be cultured from sputum or blood and are also not visible by gram-staining. This makes diagnosis of atypical CAP bacteria by standard techniques almost impossible. One of the most often occurring atypical CAP bacteria is Mycoplasma pneumoniae. Up to 20% of community-acquired pneumonia cases are caused by M. pneumoniae.
M. pneumoniae is a highly contagious bacteria without cell wall and belongs to the family of Mycoplasmataceae. It is primarily transmitted via droplet infection or via direct or indirect contact through smear infections. The incubation time is 1 – 4 weeks. M. pneumoniae is not part of the normal human flora and is most often detected in children and young adults. In 5 – 25% of M. pneumoniae infections, pneumonia will develop which requires antibiotic treatment. In the US, there are 2 million cases yearly, of which 100,000 cases lead to hospitalization of the patient.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 month after production|
|Sensitivity||Analytical Sensitivity : ≥ 10 DNA copies per reaction|
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.