使用 AccuGENX-ID® 进行微生物测序

While fungal contamination typically occurs less often than bacterial contamination, it can still result in significant consequences for the manufacturing process, final product, and the patient. Fungal contamination is also under increased scrutiny by regulatory bodies after several high-profile contamination events.

DNA sequencing for microbial identification is considered the gold standard as this method provides the most accurate and reproducible identifications.

Some organisms are very closely related and have the same 16S or ITS2 sequences. In order to identify these organisms to the species level, an alternative gene must be sequenced. Accugenix^® offers this validated assay through our ProSeq service.

With the emergence of DNA sequencing as the gold standard for classification and identification, scientists are correcting past taxonomic errors that were caused by solely phenotypic characterization and not phylogenetic relatedness. The Accugenix^® libraries are continuously curated and updated to reflect taxonomic changes and inclusion of novel organisms encountered in manufacturing environments. These taxonomic updates ensure that you get the most accurate identification and allow for a robust tracking and trending program.

While microbial identification by Sanger sequencing is considered the gold standard, the accuracy of the method is dependent on how the data is generated, how the data is analyzed, and the microbial reference library used. There are differences, then, in overall ID rates, accuracy, and reproducibility across different microbial sequencing platforms. Our poster, Comparison of Sequencing Identification Platforms used for Investigations and for Routine Water and Environmental Monitoring, provides great examples.

While customers always have the choice to identify isolates by MALDI-TOF identification technology or DNA sequencing, DNA sequencing will give the most accurate and reproducible identification. The phylogenetics provided by sequencing give additional information that can be relevant to manufacturing. When deciding between methods, the criticality and impact of that sample should be considered.

Accugenix^® uses the ITS2 region, which has proven to be the most widely accepted DNA sequence for fungal identification. It is recognized for the identification of fungal species via DNA sequence signatures by the European Consortium for the Barcode of Life.

ITS2 has more variability than the D2 region, thus providing greater specificity between organisms. This yields a much higher resolution in species identification than D2. See case studies.