When there is a major excursion, a sterility failure with a product on hold or production that ceases, thorough characterization of the microbial population in the manufacturing environment through strain typing is the preferred method for sourcing the contaminant. Investigative programs that only utilize the genus and species name of an organism may not provide enough information to make definitive conclusions in an investigation. The species name alone may not provide the appropriate information to develop a response to a contamination event if there is the potential for multiple strains as sources for that contamination. Many times it is necessary to differentiate microbial flora to the sub-species or strain level to definitively determine the source of contamination. Additionally, strain typing is critical for the probiotics industry to assure that the exact strain of the probiotic microorganism in production is established.
Services offered for strain typing
AccuGENX-ID® and AccuBLAST® provide the most accurate, reproducible and reliable species-level identifications. Resolution below the species level to the sub-species or strain level usually requires single or multi-locus sequence typing (SLST, MLST) or ribotyping methods. In some cases, ribotyping is ineffective as some species have very little diversity within the ribosomal RNA operon analyzed by the RiboPrinter®. With the addition of sequence-based methods for strain typing and characterization, the AccuGENX-ST™ service provides a much higher level of discrimination and repeatability than automated ribotyping.