SPADA at AOAC Annual Meeting 2023

oratories; method developers and end users; national laboratory and inter- national threat agent researchers; and reference material providers, among others Their expertise and participa- tion are integral on the advisory panel, working groups, and as part of the larger stakeholder body to ensure that efforts are relevant, timely, and meet the needs of the community SPADA is AOAC's first stakeholder panel [now program] established for development of community-based vol- untary consensus standards of recent time SPADA first convened in March 2007, and since then has made sig- nificant advancements in the effort to build an enduring national capacity The first Standard Method Performance Requirements (SMPRs ® ) as we know them today were approved by SPADA in 2010 to detect and iden- tify biological threat agents, starting with polymerase chain reaction (PCR) methods for B. anthracis, Yersinia pestis, and Francisella tularensis in aerosol collection filters and/or liquids While SMPRs were not new to AOAC, they increasingly gained popularity as the Association executed activities in biothreat detection and other areas During this time, AOAC experienced a move toward SMPRs to address criti- cal needs through consensus, with the ultimate goal of translating them into AOAC-validated methods In January 2009, AOAC extended its work with DHS-HSARPA with another contract signing, kicking off the next phase of the initiative to provide inde- pendent, third-party evaluation and validation of portable PCR-based assays for the detection of B. anthracis in vis- ible powders and immunological-based assays for B. anthracis spores and ricin in visible powders AOAC successfully completed the initial contract with DHS-HSARPA to build a standard program for the development, validation, and use of threat agent detection technologies on May 31, 2013 Due to AOAC’s success in developing and delivering consen- sus standards for priority agents and technologies, over the next 10 years

the Association secured additional contracts and contract modifications to extend the original scope of work to new biothreat agents, matrices, and technologies identified as high priorities In addition to DHS-HSARPA, SPADA spurred contracts with the U S Department of Defense (DoD), DHS- Directorate of Science and Technology (S&T), The Johns Hopkins University Applied Physics Laboratory (JHU/APL), and Deputy Undersecretary of the Army-Test and Evaluation (DUSA-TE) These contracts resulted in AOAC SPADA SMPRs covering: n Bacillus anthracis n Francisella tularensis n Yersinia pestis n Ricin n Burkholderia mallei n Burkholderia pseudomallei n Variola virus n Coxiella burnetii n Venezuelan equine encephalitis virus n Staphylococcal enterotoxin n Brucella suis n Botulinum neurotoxin n Aerosol collection filters and/or liquids n Visible powders n Field-deployable, DoD aerosol col- lection devices n PCR-based assays n Portable PCR-based technologies n Immunological-based hand-held assays (HHAs) n DNA-based methods In addition to SMPRs, SPADA has developed seven validation guidelines for biothreat detection, the majority of which are published as appendices to the Official Methods of Analysis of AOAC INTERNATIONAL (OMA) com- pendium Guidance topics focus on: n Systems suitability requirements n Environmental factors n Soil testing n In silico analysis n Bacterial strain verification n Amplicon sequencing n Next-generation sequences The latter two guidance were most recently approved by SPADA in December 2022 Developed by the AOAC SPADA Working Group

on Detection Standards—Amplicon Sequencing, chaired by Shanmuga Sozhamannan, Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND EB), and Logistics Management, “Amplicon Sequencing Minimal Information (ASqMI): Quality and Reporting Guidelines for Actionable Calls in Biodefense Applications,” sets stan- dards for the reporting of amplicon sequencing approaches for rare detection to address issues regarding confidence in biodefense workflows The paper is being published in the Journal of AOAC INTERNATIONAL. “Standard Requirements for Nucleotide Sequences Used in Biothreat Agent Detection, Identification, and Quantification: Verified Next- Generation Sequences (VNGS)” will be published as an appendix to the OMA compendium Along the way, SPADA participated in additional activities critical to the successful development of an enduring national capacity, including: n Facilitating a town hall-style meet- ing to provide a forum for those directly involved in threat detec- tion technologies to collectively voice their concerns and interests on a strategy to help DHS drive the future direction of the program and submitting recommendations n Reviewing and endorsing two ASTM standards for revised procedures for sampling of visible powders and an accompanying operational guidance for initial response to a suspected biothreat agent Hosting a workshop to provide a comprehensive overview of AOAC methods validation for PCR- and antibody-based HHAs to detect select biological threat agents Lessons Learned and New Concepts Whenever a large project covers uncharted territory—as this one did for AOAC which mostly focuses on food (Continued on page 20) n

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