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請問檢驗方法是否一定要訂定定量極限? 【發布日期:2021-12-10】 發布單位:研究檢驗組

1.  「食品化學檢驗方法之確效規範」中附註2提到:「檢驗方法應用之檢體濃度遠大於方法推估之定量極限時,則無需評估方法之定量極限。」

2.  本附註引用自NATA文件a,原文為: “The determination of the limit of detection (LOD) or limit of quantitation (LOQ) is normally only required for methods intended to measure analytes at concentrations close to zero. There is no need to estimate the LOD or LOQ for methods that will always be applied to measure analyte concentrations much greater than the LOQ.”

3.  AOAC文件(3.4.6)b指出,定量極限大多用於殘量級汙染物等之監控,針對成分規格(composition specification)檢驗而言,合格與否取決於是否落在規格數值範圍內,接近0的數值並不影響結果判定,故無需評估方法之定量極限。

a National Association of Testing Authorities. 2018. General guidelines for the validation and verification of chemical test methods.

b AOAC OFFICIAL METHODS OF ANALYSIS. 2012. Guidelines for Dietary Supplements and Botanicals. Appendix K, p. 11.