Elisabeth Halbmayr-Jech 1 , Roman Kittl 1 , Patrick Weinmann 1 , Christopher Schulz 1 , Anna Kowalik 1 , Christoph Sygmund 1 , Sharon Brunelle 2 . Show Affiliations »
Abstract
BACKGROUND: The AOAC Stakeholder Panel on Strategic Food Analytical Methods approved Standard Method Performance Requirements (SMPR®) 2018.009 for lactose in low-lactose or lactose-free milk, milk products, and products containing dairy ingredients. The LactoSens®R Method is a biosensor assay kit developed for the determination of lactose in a variety of lactose-free or low-lactose milk, dairy, and infant formula products produced with yeast-neutral lactases. OBJECTIVE: In response to a call for methods, the LactoSensR method was validated in a single laboratory study with comparison to SMPR 2018.009. METHOD: The LactoSensR method was evaluated for calibration, interference, repeatability, recovery, and robustness. In a method comparison study samples naturally containing low levels of lactose were evaluated using LactoSensR and an accredited high-performance anion-exchange chromatography with pulsed amperometric detection. RESULTS: Calibration with lactose standard solutions was shown to be linear and the method was shown to be free of interference from a variety of sugars, vitamins, alcohols, flavorings, and other compounds. Matrix studies, including 85 spiked materials, 55 products naturally containing lactose, and 13 reference materials, resulted in RSDr of 0-10.5% at 8-100 mg lactose/100 g and 0.2-5.4% at >100 mg lactose/100 g for milk and dairy products and 1.0-6.8% for infant formula, in compliance with SMPR 2018.009 with few exceptions. Recovery was 85.0-110.3% at 8-100 mg lactose/100 g and 85.6-109.7% at >100 mg lactose/100 g for milk and dairy products and 91.1-97.0% for infant formula, also meeting the performance requirements with few exceptions. The method was shown to be robust to changes in ambient temperature, sample temperature, and sample volume. CONCLUSIONS: The LactoSensR method compares favorably with the requirements of SMPR 2018.009 and should be adopted as a First Action AOAC Official MethodSM. HIGHLIGHTS: The LactoSensR method is a fast, easy-to-use method that meets the requirements of SMPR 2018.009. © AOAC INTERNATIONAL 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
BACKGROUND: The AOAC Stakeholder Panel on Strategic Food Analytical Methods approved Standard Method Performance Requirements (SMPR®) 2018.009 for lactose in low-lactose or lactose -free milk, milk products, and products containing dairy ingredients. The LactoSens ®R Method is a biosensor assay kit developed for the determination of lactose in a variety of lactose -free or low-lactose milk, dairy, and infant formula products produced with yeast -neutral lactases. OBJECTIVE: In response to a call for methods, the LactoSensR method was validated in a single laboratory study with comparison to SMPR 2018.009. METHOD: The LactoSensR method was evaluated for calibration, interference, repeatability, recovery, and robustness. In a method comparison study samples naturally containing low levels of lactose were evaluated using LactoSensR and an accredited high-performance anion-exchange chromatography with pulsed amperometric detection. RESULTS: Calibration with lactose standard solutions was shown to be linear and the method was shown to be free of interference from a variety of sugars , vitamins, alcohols , flavorings, and other compounds. Matrix studies, including 85 spiked materials, 55 products naturally containing lactose , and 13 reference materials, resulted in RSDr of 0-10.5% at 8-100 mg lactose /100 g and 0.2-5.4% at >100 mg lactose /100 g for milk and dairy products and 1.0-6.8% for infant formula, in compliance with SMPR 2018.009 with few exceptions. Recovery was 85.0-110.3% at 8-100 mg lactose /100 g and 85.6-109.7% at >100 mg lactose /100 g for milk and dairy products and 91.1-97.0% for infant formula, also meeting the performance requirements with few exceptions. The method was shown to be robust to changes in ambient temperature, sample temperature, and sample volume. CONCLUSIONS: The LactoSensR method compares favorably with the requirements of SMPR 2018.009 and should be adopted as a First Action AOAC Official MethodSM. HIGHLIGHTS: The LactoSensR method is a fast, easy-to-use method that meets the requirements of SMPR 2018.009. © AOAC INTERNATIONAL 2020. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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Year: 2020
PMID: 33063104 DOI: 10.1093/jaoacint/qsaa080
Source DB: PubMed Journal: J AOAC Int ISSN: 1060-3271 Impact factor: 1.913