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題名 | 101年B型肝炎表面抗體診斷試劑效能評估調查研究=Post-Market Performance Study of Anti-HBs Test Kits |
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作者 | 林佳蓓; 黃玉卉; 陳凱偉; 王德原; 施養志; | 書刊名 | 食品藥物研究年報 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁179-186 |
分類號 | 412.36 |
關鍵詞 | 後市場調查; 靈敏度; B型肝炎表面抗體診斷試劑; Post-market performance survey; Analytical sensitivity; Anti-HBs test kits; |
語文 | 中文(Chinese) |
中文摘要 | 為因應我國 99年公告體外診斷醫療器材查驗登記審查準則修訂 Anti-HBs產品靈敏度至 <10 mIU/mL,101年度以 WHO之國際標準品,針對目前市售之所有 B型肝炎病毒表面抗體診斷試劑進行效能品質監測,以源頭與隨機抽樣方式,商請各地衛生局協同本計畫研究人員直接向轄區內之許可證持有廠商、代理商及產品使用單位 (各縣市醫學中心、地區醫院及檢驗所 )抽樣產品進行試驗分析。源頭抽得 9件手動及自動品項 (9張許可證 ),市售隨機抽樣抽得 19件手動及自動品項 (5張許可證 )。研究結果顯示,外觀標示部分,所有產品之外盒皆有中文標示及衛署醫器字號。於本次抽得產品中,其中 1件國產手動產品及 1件輸入自動機台產品,其檢驗靈敏度不符合目前國內公告之查驗登記審查準則 (<10 mIU/mL)。上述不合格產品之檢驗結果皆已交轄區衛生局及醫粧組進行後續行政作業,其中不合格之國產手動產品已於 101年度 8月份申請自行撤銷許可證。本計畫係本組系統性針對第三等級 B型肝炎體外診斷試劑進行之全面性效能評估,除有效篩選出不良產品,並透過行政程序確保市售診斷試劑品質外,更建立 TFDA製備生物性國家標準品之最佳運用範例,作為日後進行其他種市售診斷試劑效能評估之模式。 |
英文摘要 | The criteria of anti-HBs sensitivity of <10 mIU/mL requirement was announced in 2010 by Department of Health, Executive Yuan, Taiwan. This was the first post-market performance survey of Anti-HBs kits carried out by TFDA. A total of 28 kits were collected from manufacturers or their authorized representatives from market with the assistance of local health personnels. All of them were found to be in compliance with labeling and packaging requirements. One domestic manually-operated kit and one import automatic-operated kit failed to fulfill the criteria for the analytical sensitivity of <10 mIU/mL. The results of the products have been reported to the local Health Bureaus and the Division of Medical Devices & Cosmetics in TFDA for further handling. In conclusion, the post-market performance survey by Division of Research and Analysis in TFDA, not only the analytical performance of the marked class Ш medical devices for Anti-HBs detection, assessed but also successfully reported the quality problem of specific devices using the National Standards set by TFDA. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。