The MALDI-TOF is a rapid identification system that identifies microorganisms by creating a finger print of highly abundant proteins that is compared to a library of known species to produce an identification result to the genus or species level. A comprehensive and well-structured Laboratory Equipment Qualification Program (LEQ) facilitated the qualification and implementation of a MALDI-TOF unit for use together with a genotypic system in a two tier approach for microbial identification in a high volume pharmaceutical microbiology laboratory.
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