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Background The LactoSens® R method was previously shown to have acceptable accuracy and repeatability precision as required by AOAC Standard Method Performance Requirements (SMPR®) 2018.009 for determination of lactose in low-lactose or lactose-free milk, milk products, and products containing dairy ingredients and was awarded Official Method of Analysis SM (OMA) First Action status in 2020. Objective The method was subjected to a multilaboratory validation (MLV) study to evaluate the reproducibility precision of the method. Methods Fourteen validation materials were provided to 15 laboratories in seven countries as blind duplicates. The materials ranged from 0 to 173 mg/100 g lactose. Each laboratory analyzed the blind duplicates according to OMA 2020.01. The data were analyzed for repeatability and reproducibility precision. Results RSDr values varied from 2.81 to 8.76%, and RSDR values varied from 4.25 to 12.5%. When sorted by category and concentration range, these results met the repeatability and reproducibility criteria required by SMPR 2018.009. Conclusions The data generated in the MLV support the adoption of OMA 2020.01 as Final Action status. Highlights The LactoSens R method, as described by OMA 2020.01 , provides an accurate and precise determination of lactose in a variety of low-lactose and lactose-free milk, milk products, and products containing dairy ingredients in minutes. [ABSTRACT FROM AUTHOR]

Background: The AOAC Stakeholder Panel on Strategic Food Analytical Methods issued a call for methods for the measurement of lactose in low-lactose and lactose-free products under Standard Method Performance Requirement (SMPRVR) 2018.009. Megazyme's Lactose Assay Kit (K-LOLAC) was developed specifically to address the need for accurate enzymatic testing in lactose-free samples. Objective: K-LOLAC was validated for measurement of lactose in low-lactose and lactose-free milk, milk products, and products containing dairy ingredients. A single-laboratory validation (SLV) of the method is reported. Method: K-LOLAC is an accurate and sensitive enzymatic method for the rapid measurement of lactose in low-lactose or lactose-free products. Validation analysis was performed on a sample set of 36 commercial food and beverage products and a set of 10 certified reference materials. Parameters examined during the validation included working range and linear range, selectivity, LOD, LOQ, trueness (bias), precision (repeatability and intermediate precision), robustness, and stability. Results: For all samples tested within the lower range (10-100 mg/100 g or mL), recoveries varied from 93.21-114.10%. Recoveries obtained for samples in the higher range (>100 mg/100 g or mL) varied from 94.44-108.28%. All materials had repeatability relative standard deviations (RSDr and RSDir) of <9%. Conclusions: The commercial K-LOLAC assay kit, as developed by Megazyme, meets the requirements set out under SMPR 2018.009. Highlights: K-LOLAC is a robust, quick, and easy method for analysis of lactose in foodstuffs and beverages. [ABSTRACT FROM AUTHOR]