AOAC INTERNATIONAL has been involved in the field of biothreat agent detection for over 15 years, evaluating and creating more than 20 standards in support of biothreat agent detection. This body of work includes standard method performance requirements, sampling standards, and method validation guidance.
SPADA was formed and today includes many of the world’s foremost biothreat detection experts. The SPADA partnership includes scientists from the U.S. Department of Defense, U.S. Environmental Protection Agency, U.S. Health and Human Services, U.S. Centers for Disease Control, U.S. Food and Drug Administration, and others.
SPADA’s unique mission is to bring together expert stakeholders from across the biothreat community to create guidance for a comprehensive and uniform approach to scientific analysis and detection of biothreat agents.
The current focus of SPADA’s Working Groups is to Develop standards, in the form of both SMPRs and guidance documents, for Next Generation Sequencing (NGS) biothreat agent detectors that encompass both PCR-based amplicon sequencing and, most recently, metagenomic applications. This is accomplished by partnering with the world’s foremost biothreat detection experts including the US Department of Defense, the US Environmental Protection Agency, US Centers for Disease Control and Prevention, US Food and Drug Administration, and others.
If you are interested in supporting SPADA or would like more information, please contact us.
This SPADA working group effort was sponsored by the U.S. Department of the Undersecretary of the Army – Test & Evaluation (DUSA T&E); the U.S. Joint Program Executive Office Joint Program Manager – Guardian Defense Biological Product Assurance Office (JPM-Guardian DBPAO); and Johns Hopkins University, Applied Physics Laboratory.
The SPADA Working Group on in silico PCR analysis drafted standard procedures for the use of in silico PCR analysis, to build confidence that analysts in different laboratories will achieve equivalent results.
Assay developers or evaluators often discover that a bacterial culture is not the expected species or strain. There is currently no consensus on the process to authenticate bacterial strain. The SPADA Bacterial Strain Verification Working Group worked to develop guidelines for the characterization and authentication of bacterial strains.
When deploying assays in the field to protect warfighters deployed in global war zones, it is critical to have a standard for evaluating how different soils affect inhibition, interference, and cross-reactivity of the assay. The SPADA Working Group on Soil Testing Samples drafted standard procedures for preparation and characterization of soils and the use of soil samples to evaluate candidate biothreat detection assays.
Chair: Dr. Tim Minogue, USAMRIID
Advances the utility of reference microbial sequencing databases to evaluate, develops and supports detection capabilities using NGS applications for deployable diagnostic kits and platforms/detectors.
Develops standards for NGS biothreat agent detectors that encompass both PCR-based amplicon sequencing applications and metagenomic applications.
Chair: Dr. Michael Sussman, USDA AMS
Creates validation criteria and confidence parameters in reference genome databases.