Qualification of Point of Need Tests

ZP is a contract developer and manufacturer of Point of Need tests, including those for Food, Beverage, Aquaculture, and Agriculture.

ZP recently witnessed the 10-year journey for a test to be granted Official Method of Analysis Final Action Status, and so we describe this in the note below.

AOAC International, formerly known as the Association of Official Analytical Chemists, is a non-profit scientific organization that focuses on the development and validation of analytical methods for testing the composition of various substances. AOAC International was founded in 1884 and has since become a globally recognized authority in the field of analytical chemistry.

The Official Methods of Analysis (OMA) program is one of the key initiatives of AOAC International. The OMA program is a comprehensive and authoritative collection of analytical methods and procedures for a wide range of commodities, including food, beverages, pharmaceuticals, cosmetics, and more. These methods are used to ensure the accuracy and reliability of analytical results in laboratories worldwide.

The Official Methods of Analysis undergo a rigorous process of development, validation, and peer review to ensure that they meet high scientific standards. These methods are utilized by laboratories, regulatory agencies, and industries to assess the quality and safety of products. The AOAC Official Methods cover a variety of analytical techniques, including chemical, physical, and microbiological methods.

The methods published in the OMA program are continuously updated to incorporate advancements in analytical technology and to address emerging challenges in different industries. AOAC International’s work plays a crucial role in promoting consistency and reliability in analytical testing, contributing to the overall quality assurance and safety of consumer products.

To achieve OMA Final Action Status can be a long process, with a recent experience taking 10 years, and requires:

Standard Method Performance Requirements (SMPRs)

SMPRs establish the minimum requirements for method evaluation, including on-site verification or single laboratory validation. Written by stakeholders such as industry representatives and regulatory organizations, SMPRs serve as the basis for validation studies. If the SMPRs do not exist, then they have to be lobbied for, discussed, and created by a committee of stakeholders, including industry representatives and regulatory organizations. Later, the Expert Review Panel uses the SMPRs to evaluate and accept methods.

The Journey to OMA Status

First Action Status – Having established or identified the SMPRs, one step on the way is to perform a Single Lab Validation Study against the SMPRs, demonstrating aspects such as linear calibration, insensitivity to interferences. The performance may be determined by the relative standard deviation (RSDR). The method may be tested for robustness against parameters such as ambient temperature, sample temperature, and sample volume. Upon review and approval by an Expert Review Panel, the assay can be given First Action Status.

Final Action Status – To progress from First Action Status to Final Action Status can take four or more years. Upon Final Action Status, the assay can be certified as an Official Method of Analysis (OMA). The Final Action Status requires a Multi-Laboratory Validation Study (MLV), fifteen or more labs may be used. The study can involve multiple validation materials (for example, yogurt, infant formulas, chocolate iced coffee); this can be done as blind duplicates. The relative standard deviation of repeatability (RSDr) and the relative standard deviation of reproducibility (RSDR) can be tested against the SMPRs. Upon review by an Expert Review Panel, the assay can be given Final Action Status.