The National Institute of Standards and Technology (NIST) awarded a grant to AOAC INTERNATIONAL in September 2024 to address the need for standards development for lateral flow immunoassay test strips meant to detect illicit drugs in tablets and powders. The standards to be developed include Standard Method Performance Requirement (SMPRs®) documents as well as specific validation protocols for test strips meant to be used for this purpose. The initial set of targeted drugs for detection include xylazine, fentanyl, and nitazenes.
As a standards development organization known for its work over the past 140 years in agricultural, food, dietary supplement, and related fields, AOAC is an independent, 501(c)(3), non-profit membership association of analytical science professionals representing government, industry, and academia worldwide. AOAC’s credibility is derived from leveraging the expertise of its international pool of volunteer subject matter experts to address analytical challenges with reliable, fit for purpose, characterized, and validated published methods.
To begin this work, AOAC intends to convene an advisory panel (AP) to establish the scope of the standards (fitness for purpose statement) and the intended use of the analytical methods or test strips. AOAC will work with NIST to determine the composition of the AP which will include representatives from NIST and experts in the field. Once the AP is formed, AOAC will work with the AP members to recruit experts from industry, government, academia, and other sectors to form and launch a technical working group who will be responsible for drafting the proposed standards. AP members will make recommendations on the technical working group (WG) co-chairs and other organizations to notify and invite to participate.
Based on the current understanding of this work, we envision two standards to be developed. First, an AOAC Standard Method Performance Requirements (SMPRs®) document specific for the use of test strips for analyzing drug product will be created. The developed draft SMPR will provide method performance requirements and will include specific stipulations for validation such that, once the draft SMPR is consensus approved, AOAC will engage a subset of the WG to develop a second standard— a companion standard method validation protocol for the validation of test strips.
The AOAC INTERNATIONAL standards development process is based on a transparent process incorporating a diverse membership of volunteers as well as a public comment period, to ensure that all perspectives of expertise are considered. Both standards will be published and may be used by test strip developers and authors to determine if their candidate method meets the SMPR through the application of the validation protocol. These standards may serve as a guide to inform end users on the expected acceptable performance and scientific scrutiny for tests, providing a benchmark for methods specific to this application.
After completion of this grant, AOAC will invite method developers to apply to the AOAC Performance Tested MethodSM (PTM) program and validate their methods via these standards, based on the needs of the end users and the method development organizations. The AOAC PTM program conducts an independent, third-party review of commercially available, proprietary methods validated according to the appropriate protocol with a goal of a formal AOAC method certification.
