For in vitro diagnostic use. RIDA®GENE CAP Bac is a multiplex real-time PCR for the direct qualitative detection and differentiation of Chlamydophila pneumoniae (Chlamydia pneumoniae), Legionella pneumophila, and Mycoplasma pneumoniae in human bronchoalveolar lavage (BAL).
The RIDA®GENE CAP Bac multiplex real-time PCR is intended to use as an aid in diagnosis for community-acquired pneumonia (CAP) caused by Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
Community-acquired pneumonia (CAP) is the most frequently recorded infectious disease worldwide and is the infectious disease which most frequently leads to death in Western nations. In Germany, there are up to 600,000 cases of CAP annually, and the mortality varies between 0.6 % and 14 % depending on whether CAP is outpatient or inpatient. Bacteria are the most frequent pathogens of CAP, and a distinction is drawn between typical and atypical pathogens. Atypical bacteria cannot be cultivated in a regular culture of sputum or blood and also cannot be visualized by gram staining. This makes it difficult to detect atypical CAP bacteria since standard methods generally make identification impossible. The most frequent atypical CAP bacteria include Mycoplasma pneumoniae (M. pneumoniae), Legionella spp., and Chlamydophila pneumoniae (C. pneumoniae).
Up to 20 % of outpatient pneumonias are triggered by M. pneumoniae. M. pneumoniae is a highly infectious bacterium without a cell wall that is primarily transmitted in the air through droplets or by direct or indirect contact through smear infections. M. pneumoniae does not belong to the normal flora of humans and is generally detected in children and young adults. Pneumonia develops in 5 % to 25 % of cases of infection with M. pneumoniae and generally requires further treatment with antibiotics.
Chlamydophila pneumoniae is a gram-negative bacteria and is generally transmitted through the air. An infection with C. pneumoniae is generally difficult to overcome, but mild. It is estimated that C. pneumoniae has a prevalence rate of 50 % to 70 %, and 60 % of the population will have experienced a C. pneumoniae infection by the age of 20. A severe case can lead to atypical pneumonia. In Germany, it is estimated that up to 5 % of CAP pneumonias are caused by C. pneumoniae. The bacteria can dwell in the upper respiratory tract for many years so the danger of infection may exist for a long time. Classic antigen detection methods such as ELISA have only a narrow specificity and can be used only after several weeks of an acute infection. PCR can detect the pathogen reliably from respiratory samples or tissues.
The Legionella strain belongs to the Legionellaceae family and is divided into 40 species with more than 70 serogroups. Legionella bacteria are facultative intracellular gram-negative bacteria whose peak infection rate occurs in summer and early fall. With Legionnaires’ disease, a differentiation is made between community acquired, travel-associated, and nosocomial infections. In the USA, the mortality rate of nosocomial infections is between 15 % and 20 %. In Europe, 12 % of all Legionella infections are fatal. All Legionella species are to be considered potentially pathogenic to humans. In Europe, however, most community-acquired illnesses are caused by pathogens of the species Legionella pneumophila serogroup 1. An infection with Legionella pneumophila primarily leads to Legionnaires’ disease (also termed legionellosis).
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months|
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.