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<p>In the field of food quality and safety supervision, discrepancies in test outcomes arising from the application of different testing methods can influence food safety supervision. Therefore, evaluating the consistency and equivalence among various testing methods is essential to support the diversification of analytical approaches. This study aims to evaluate the equivalence among three methods for determining vitamin K<sub>1</sub> in infant formula: Method I in GB 5009.158-2016 (hereafter referred to as GB 1), Method II in GB 5009.158-2016 (hereafter referred to as GB2), and AOAC Official Method SM 2015.09 (hereafter referred to as AOAC). The assessment combined method performance evaluation with evaluation of analytical result consistency, employing both qualitative and quantitative statistical tools. There were no significant differences in performance among the three methods. Analysis of variance (ANOVA) revealed no statistically significant differences among the three methods. When the equivalence threshold was set at 8%, two one-sided <i>t</i>-tests (TOST) confirmed the consistency of analytical results among the three methods. Regression analysis and Bland–Altman plots confirmed the consistency between GB1 and GB2. Although proportional differences were observed between AOAC and the two GB methods, these differences remained below 15%, indicating a high degree of agreement. This study also pioneers the application of an environmental sustainability perspective in method comparison, noting that AOAC already meets sustainability and greenness assessment criteria. These findings provide a reference for selecting and aligning national and international food-safety standard testing methods.</p>

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Equivalence Evaluation of the Chinese National Standard and the AOAC Official Method for Vitamin K1 Determination in Infant Formula

  • 期刊论文

  • 发表日期：

    2026年1月28日

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  • Jiale Huang,
  • Xiuying Li,
  • Minheng He,
  • Senyu Lin,
  • Xiaoqing Yao,
  • Hua Dang,
  • Qiying Zeng

摘要

In the field of food quality and safety supervision, discrepancies in test outcomes arising from the application of different testing methods can influence food safety supervision. Therefore, evaluating the consistency and equivalence among various testing methods is essential to support the diversification of analytical approaches. This study aims to evaluate the equivalence among three methods for determining vitamin K1 in infant formula: Method I in GB 5009.158-2016 (hereafter referred to as GB 1), Method II in GB 5009.158-2016 (hereafter referred to as GB2), and AOAC Official Method SM 2015.09 (hereafter referred to as AOAC). The assessment combined method performance evaluation with evaluation of analytical result consistency, employing both qualitative and quantitative statistical tools. There were no significant differences in performance among the three methods. Analysis of variance (ANOVA) revealed no statistically significant differences among the three methods. When the equivalence threshold was set at 8%, two one-sided t-tests (TOST) confirmed the consistency of analytical results among the three methods. Regression analysis and Bland–Altman plots confirmed the consistency between GB1 and GB2. Although proportional differences were observed between AOAC and the two GB methods, these differences remained below 15%, indicating a high degree of agreement. This study also pioneers the application of an environmental sustainability perspective in method comparison, noting that AOAC already meets sustainability and greenness assessment criteria. These findings provide a reference for selecting and aligning national and international food-safety standard testing methods.