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103年度動物用藥(孔雀綠及其代謝物)檢驗之能力試驗

Results of Proficiency Testing in 2014: Veterinary Drug Residues of Malachite Green and its Metabolite in Foods

摘要


103年度食品藥物管理署(下稱食藥署)舉辦檢驗機構對於動物用藥(孔雀綠及其代謝物)檢驗能力試驗,測試樣品係以魚肉為基質,內含孔雀綠及還原型孔雀綠,參與測試之檢驗機構有18家,包括4縣市衛生局及14家民間檢驗機構,孔雀綠及其代謝物判定標準係以Robust-Z或測試值之合格範圍擇優者為評定結果。評列為「滿意」有16家,佔88.9%,「不滿意」有2家檢驗機構,佔11.1%。本次參加之檢驗機構為食藥署認證項目者共計11家,皆呈滿意結果。透過本次能力試驗,可知檢驗機構對動物用藥(孔雀綠及其代謝物)之檢驗能力表現良好,且提供檢驗機構間檢驗技術能力鑑別之機會。能力試驗結果可作為檢驗機構持續改進其品質管理系統之參考,以及食藥署監控認證檢驗機構之檢驗品質依據之一。

並列摘要


A proficiency testing was held in 2014 in order to understand the analytical competency of laboratories in testing for the veterinary drug residues of malachite green and its metabolite in foods. Fish muscle was used as the testing material and was shown to be consistent and effective in terms of homogeneity and stability. A total of 18 laboratories participated in the test, including 4 local health bureaus and 14 private laboratories. The analytical results were analyzed using Robust-Z and categorized as follows: |Z| score ≦ 2 was “satisfactory”, 2 < | Z | < 3 was “acceptable” and | Z | ≧ 3 was “unsatisfactory”. The amounts of malachite green and its metabolite in the test samples should be in the range of 1.40-3.59 ppb and 0.75-1.92 ppb, respectively. The better of the two results was used. Among the 18 laboratories, 16 and 2 laboratories were graded as satisfactory and unsatisfactory, respectively. Laboratories graded in the category of “unsatisfactory” were all unaccredited laboratories. Laboratories with accredited items were all found to be satisfactory in this proficiency test. This test provided the opportunity for laboratories to assess their performance in relation to other laboratories and make necessary improvements to their quality system.

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