Intended use
The AltoStar® Pneumocystis jirovecii PCR Kit 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the detection and quantification of Pneumocystis jirovecii specific DNA in human bronchoalveolar lavage specimens. It is intended to be used as an aid for diagnosis of Pneumocystis jirovecii infection and for monitoring of the Pneumocystis jirovecii load in individuals with Pneumocystis jirovecii infection.
The results generated with the AltoStar® Pneumocystis jirovecii PCR Kit 1.5 have to be interpreted in conjunction with other clinical and laboratory findings.
The AltoStar® Pneumocystis jirovecii PCR Kit 1.5 is intended for use by professional users trained in molecular biological techniques and in vitro diagnostic procedures.
