Based on extensive validation data from single and multi-laboratory studies AOAC International food safety experts and AOAC Official Methods Board have granted the LactoSens®R Official Method of Analysis (OMA) Final Action Status for measurement of low levels of lactose in dairy products.
AOAC International and the Official Methods of Analysis (OMA) program
AOAC International, an independent, nonprofit association of analytical scientists worldwide, promotes food safety and product integrity through standards and validated testing methods. The Official Methods of Analysis (OMA) program is their premier methods program. Under strict scientific scrutiny, it ensures the credibility and incontestability of the approved methods. This collection of chemical and microbiological methods and consensus standards is considered the most comprehensive and reliable for the analysis of food and environmental samples.
The importance of SMPRs in method validation
The AOAC Standard Method Performance Requirements (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. The Expert Review Panel uses these criteria to evaluate and accept methods. The requirements for Low Lactose (SMPR 2018.009), served as the evaluation basis for the LactoSens®R method.
LactoSens®R – The path to OMA status
For First Action Status the LactoSens®R underwent a Single Lab Validation Study, in which it was compared to the SMPR 2018.2009. It showed linear calibration and was insensitive to interference from various compounds. Matrix studies revealed an RSDr within the acceptable range and recovery met the performance requirements for lactose in milk and milk products. The method proved to be robust to ambient temperature, sample temperature and sample volume. In 2019, the data was approved by the Expert Review Panel and given First Action Status.
To achieve Final Action Status and be certified as an OMA, the LactoSens®R underwent a Multi-Laboratory Validation Study (MLV). Fourteen validation materials like yoghurt, infant formula, chocolate iced coffee, and more were analyzed as blind duplicates in a total of 15 laboratories in Austria, Germany, Italy, Denmark, Sweden, Spain, and Switzerland. The RSDr and RSDR values met the repeatability and reproducibility criteria of the requirements. The data generated in the SLV and MLV gave the following result: