The co-chairs of the Adventitious Virus Detection Technologies Interest Group provided an update on the group’s activities during the
interest group session at the 2019 PDA Virus Safety Forum, May 8, in Long Beach, Calif.
Currently, the interest group is divided into three subgroups, each focused on one of the following deliverables: experimental protocols, a
reference database and pipeline analysis and follow-up strategies.
The subgroup focused on experimental protocols is working on sample preparation related to viral detection using next generation
sequencing, this includes identifying standards and reference materials that can be used for spiking studies to evaluate the performance of
next generation sequencing. At this time, the subgroup is discussing a new spiking study to explore transcriptomics to evaluate detection
of infected cells among a background of uninfected cells.
The second subgroup is tasked with identifying gaps in the new Reference Virus Database, a database developed within CBER at the
U.S. FDA. This subgroup is developing criteria for a well-characterized database to support next generation sequencing analysis, identifying
additional databases and working with the third subgroup on annotation.
The third subgroup is evaluating the characteristics of a good bioinformatics pipeline and designing best practices for follow-up investigations
of next generation sequencing signals. In addition to working with the second subgroup on annotation, this subgroup is establishing
ranges of bioinformatics criteria and thresholds for a positive hit, identifying the sources of background signals and how to control
for them, developing controls for an assay that might facilitate follow-up investigations and assessing the effectiveness of laboratory
follow-up procedures on representative contaminant.
The mission of the Adventitious Virus Detection Technologies Interest Group is to “advance next generation tools for viral risk evaluation
by providing an informal, scientific forum for discussions and scientific collaborations.” The group’s current focus is next generation
sequencing. For more information and to join, visit their page on PDA ConnectSM.