OMA Consulting Protocol Review: OMACON-2019-2

The BIOMILK 300 LAC method will be validated according to AOAC INTERNATIONAL policies and procedures against performance requirements as outlined in the Standard Method Performance Requirements (SMPRs ® ) for Lactose in Low-Lactose or Lactose- Free Milk, Milk Products, and Products Containing Dairy Ingredients, AOAC SMPR 2018.009 (Appendix 2). The scope of SMPR 20018.009 is to measure lactose found in milk, milk products, and products containing dairy ingredients that are low-lactose or lactose-free. SMPRs® are a unique and novel concept for the analytical methods community. SMPRs are international voluntary consensus standards, developed by stakeholders, that prescribe the minimum analytical performance characteristics to be used during the evaluation of a method. AOAC SMPRs are used by AOAC expert review panels in their evaluation of validation study data for methods being considered for Performance Tested Methods SM or AOAC Official Methods of Analysis SM . This validation has two main parts: Single Laboratory Validation (SLV) to obtain Official Method First Action Status and a Multi-Laboratory Validation to achieve Final Action Status. This study outline will provide guidance on the SLV Studies. Testing generated during the SLV studies must meet the performance requirements as outlined in SMPR 2018.009 to achieve Official Method First Action Status.

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SINGLE LABORATIVE VALIDATION (SLV) STUDIES

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Overview

The SLV studies will generate method performance data that meets or exceeds the requirements set forth in SMPR 2018.009. SLV studies will generate data for the applicable range of the method (linearity), interference and cross-reactivity, recovery (matrix studies), bias, LOD/LOQ, precision, robustness and stability/lot-to-lot. Lactose Test Method Claim: Whole UHT milk, Yogurt (normal, flavored, liquid flavored and Greek), cream, chocolate milk shake, spreadable soft cheese, infant formula, protein powder, ice cream. Analyte:

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