P. jirovecii is the causative agent of Pneumocystis Pneumonia (PCP), which is one of the most common, and most severe, opportunistic infections in immunocompromised patients. It is still debated whether PCP is the result of the reactivation of a latent childhood infection, or a de novo infection.
eazyplex® Pneumocystis jirovecii is a manual, in vitro, diagnostic medical device for the qualitative detection of a specific nucleic acid sequence (DNA) of Pneumocystis Jirovecii by the means of the LAMP technique ("Loop-mediated isothermal AMPlification") from bronchoaveolar lavage (BAL), broncheal secretions (BS), or tracheal secretions (TS) of patients with suspected Pneumocystis Pneumonia (PCP).
Intended purpose of the test:
- The eazyplex® Pneumocystis jirovecii is an aid to the diagnosis of PCP and should therefore not be used as the sole criterion for diagnosis.
Protective mechanisms preventing the use of false results:
- Performance of "inhibition control" with each sample prevents the use of false negative test results, due to the inhibition of the amplification reaction whilst simultaneously serving as reagent control.
- The test result is only displayed if the inhibition control is valid.
- As required, a test strip can be processed as negative/ contamination control by testing RALF without addition of sample material. In this case, only the inhibition control is allowed to create a positive signal
