VIASURE Pneumocystis jirovecii Real Time PCR Detection Kit for BD MAX™ System is an automated real-time PCR test designed for the qualitative detection of Pneumocystis jirovecii DNA in respiratory samples (bronchoalveolar lavage) from patients suspected of respiratory infection by their healthcare professional (HCP).
This test is intended to be used as an aid in the identification of Pneumocystis jirovecii in combination with patient’s clinical signs and symptoms and epidemiological risk factors.
The assay uses the BD MAX™ System for automated extraction of DNA and subsequent real-time PCR, employing the reagents provided combined with universal reagents and disposables for the BD MAX™ System. DNA from respiratory samples is detected using fluorescent reporter dye probes specific for Pneumocystis jirovecii.
Pneumocystis jirovecii pneumonia (PCP) is an acute and life-threatening lung disease caused by the fungus Pneumocystis jirovecii. PCP is an important disease of immunocompromised humans, particularly patients with HIV, but also patients with an immune system that is severely suppressed for other reasons. In humans with a normal immune system, it is an extremely common silent infection. In developing regions of the world, the prevalence of PCP was once thought to be much lower, but studies have shown that the lower reported incidence is likely a failure to accurately diagnose.
The symptoms of PCP are nonspecific, in patients with HIV tends to present much later, often after several weeks of symptoms, compared with PCP associated with other immunocompromising conditions. Symptoms of PCP include the following: progressive exertional dyspnea, fever, non-productive cough, chest discomfort, weight loss, chills and hemoptysis (rare).
PCP is difficult to diagnose as a result of the associated nonspecific signs and symptoms. Because P. jirovecii cannot be propagated in culture, microscopic visualization of cysts or trophic forms in pulmonary specimens with cytochemical or immunofluorescent staining with monoclonal antibodies and/or DNA amplification are the standard procedures to detect this microorganism.
VIASURE Pneumocystis jirovecii Real Time PCR Detection Kit for BD MAXTM System:
CERTIFICATE OF ANALYSIS