Claudio Denoya (Pfizer) provided an overview of how his team is validating the Pall GeneDisc rapid microbiology system. Specificity testing was conducted using purified DNA from 6 different organisms represented by the system's Specified Microorganism detection plate, and excellent linearity was observed. They also evaluated the system's ability to detect the presence of the target DNA in the presence of a variety of excipients, such as magnesium stearate, mannitol and propylene glycol, and demonstrated very good linearity and a low limit of detection during these studies. Ruggedness was also assessed using different lots of reagents and multiple operators, and robustness was evaluated using frozen filters and nucleic acids held overnight under refrigeration.
This comment has been removed by the author.
ReplyDelete