- 期刊
103年B型肝炎表面抗原及表面抗體診斷試劑之效能評估
Post-Market Performance Evaluation of HBsAg and Anti-HBs Test Kits
摘要
為因應我國102年修正公告之體外診斷醫療器材查驗登記審查準則修訂靈敏度(B型肝炎表面抗原試劑檢測靈敏度至≦0.13 IU/mL，B型肝炎表面抗體試劑檢測靈敏度至＜10 mIU/mL)，以及食藥署於歷年後市場效能評估調查結果發現部分產品之外觀標示及靈敏度未能達到我國體外診斷醫療器材查驗登記審查準則之要求，本次監測研究將針對手動操作產品及之前發現效能不符準則要求之產品加強抽測。本計畫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，並以食藥署製備之「B型肝炎表面抗原 ad 亞型之標準品」及WHO國際標準品進行效能評估分析。本計畫預計抽樣產品中，除2件手動操作產品停產、2件手動操作產品未進貨無法抽樣外，總計源頭抽得2件手動操作產品(2張許可證，皆是抗原產品)及1件自動化操作品項(1張許可證，抗體產品)，市售隨機抽樣抽得19件自動化操作產品(5張許可證，包含2件抗原及3件抗體產品)。研究結果顯示，同時該產品之靈敏度效能皆符合標準，B型肝炎表面抗體診斷試劑抽樣產品之靈敏度試驗於10 mIU/mL稀釋結果皆為陽性。外觀標示部分，有1件產品外包裝標示之中文品名及許可證字號與許可證登錄不符；上述標示不符產品已交轄區衛生局及食藥署醫粧組進行後續行政作業。本計畫係系統性針對第三等級B型肝炎表面抗原及抗體之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，透過行政程序確保市售診斷試劑品質外，更建立食藥署製備生物性國家標準品之最佳運用範例，並作為日後進行其他市售診斷試劑效能評估之模式。
並列摘要
A new criteria for in vitro diagnostic devices (IVDD) was announced in 2013 by the TFDA. In this study, we have conducted quality assessment evaluation for the products that have failed to meet the requirements for in vitro diagnostic medical devices in past year. From our results, we established a guideline for sensitivity testing for in vitro diagnostic medical devices. With the assistance of local head personnel, a total of 22 kits were collected from manufacturers or their authorized representatives. All of the samples collected satisfied the new performance criteria, although one imported kit was found to be mislabeled. The results of this investigation have been reported to the local Heath Bureau and Division of Medical Devices & Cosmetics of the TFDA for further action. In conclusion, this study not only systemically evaluated and detected the performance of class III medical devices for HBsAg and anti-HBs, but also successfully reveal the quality concerns of specific medical devices under standards reinforced by the TFDA.