On October 25, AOAC International announced that it has received a National Institute of Standards and Technology (NIST) Measurement Science and Engineering (MSE) grant for development of testing standards for illicit drugs, including fentanyl, xylazine, and nitazenes.
This grant will be part of a new collaborative scientific initiative to address the need for standards that define the desired performance of lateral flow immunoassay test strips to detect illicit drugs in tablets and powders. The test strips will fill a need for field-use rapid testing capabilities. AOAC plans to use its collaborative process in concert with NIST scientists and a panel of experts to create voluntary consensus standards to meet this need as part of the one-year grant.
The MSE grants provide financial assistance to support research in broad areas, such as advanced network technologies, Big Data, cloud computing, computer forensics, information access, information processing and understanding, cybersecurity, health information technology (1). The ITL’s mission is to cultivate trust in information technology (IT) and metrology, accomplishing this via world-class measurement and testing facilities, all while encompassing a wide range of areas of computer science, mathematics, statistics, and systems engineering (2).
AOAC International was founded in 1884 with associations with the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). An independent and non-profit membership association of analytical science professionals in government, industry, and academia, the group boasts its mission of “[advancing] food safety and product integrity through standards, validated test methods, and laboratory quality programs.” The company publishes its own academic journal, the Journal of AOAC INTERNATIONAL, and provides laboratory proficiency testing programs.
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According to Ed Sisco, a Research Chemist with NIST, “Test strips are a critical tool for public health, law enforcement, and others to detect fentanyl, xylazine, and other illicit drugs in samples. Currently, no standards or requirements for test strips used for drug checking exist, which presents several challenges including understanding what other chemicals a test strip will cross-react with or whether environmental storage conditions affect performance.” By working with AOAC International to establish minimum performance requirements, Sisco said that manufacturers and end-users will be better positioned to ensure that test strips are fit-for-purpose and that limitations are known.
Katerina Mastovska, deputy executive director and chief science officer at AOAC International, said in a press release that the grant will help deliver standards and ensure reliable detection of illicit drugs in tablets and powders. “AOAC has significant experience in partnering with government agencies and addressing their needs for development of voluntary consensus standards and validated test methods,” Mastovska said. “We are excited to collaborate with NIST and other stakeholders on addressing this important public health and safety issue.”
In 2020, MSE awardees included the Board of Trustees of the Leland Stanford Junior University for their assessment on artificial intelligence (AI) risk, George Washington University for their work on quantifying and explaining human-like biases in visual semantics, and Michigan State University for their work on synthesizing one billion fingerprints (3).
(1) ITL Measurement Science and Engineering (MSE) Grant Program. NIST 2024. https://www.nist.gov/itl/itl-measurement-science-and-engineering-grant-program (accessed 2024-10-30)
(2) ITL MSE Grant Application Process. NIST 2024. https://www.nist.gov/itl/itl-mse-grant-application-process (accessed 2024-10-30)
(3) Measurement Science and Engineering (MSE): FY2020 Financial Assistance Awards. NIST 2024. https://www.nist.gov/system/files/documents/2020/09/29/itl-mse-financial-assistance-awards-fy-2020.pdf (accessed 2024-10-30)
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Pharmaceutical excipients, such as polyethylene glycol-based polymers, must be tested for the presence of ethylene oxide (EtO) and 1,4-dioxane as part of a safety assessment, according to USP Chapter <228>.