For in vitro diagnostic use. RIDA®GENE Pneumocystis jirovecii is a multiplex real-time PCR for the direct qualitative and quantitative detection of Pneumocystis jirovecii from human bronchoalveolar lavage fluid (BAL).
The RIDA®GENE Pneumocystis jirovecii multiplex real-time PCR is intended to use as an aid in diagnosis for respiratory infections caused by Pneumocystis jirovecii.
Pneumocystis jirovecii (former P. carinii) belongs to the family of Pneumocystidaceae and leads to an interstitial pneumonia. Opportunistic infections are a major problem in immunocompromised patients, for example HIV/AIDS patients, chemotherapy-treated patients and patients receiving an organ transplant. Pneumocystis jirovecii causes respiratory infections and is the most common opportunistic illness in HIV-infected people. Pneumocystis jirovecii does not cause any harm in healthy people and is widely spread among the normal population. However, immunocompromised people infected with Pneumocystis jirovecii, develop pneumonia with symptoms including dry cough, shortness of breath, tachypnoe and fever. Although HAART therapy decreased the Pneumocystis jirovecii incidence by 3.4 % per year after 1996, it is estimated that still 9 % among hospitalized HIV/AIDS patients and 1 % among solid organ transplant recipients are infected. According to the Center for disease control (CDC), Pneumocystis jirovecii causes 100 % mortality in patients without treatment and the mortality rate in immunocompromised patients is between 5 % – 40 % in treated patients. The mortality from Pneumocystis jirovecii in HIV-uninfected patients can be as high as 40 %.
|Test format||real-time PCR with 100 reactions|
|Shelf life||24 months 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.