100年度B型肝炎表面抗原診斷試劑效能評估調查研究

Post-Market Performance Study of HBsAg Test Kits

林佳蓓(Chia-Pei Lin) ； 方怡雅(Yi-Ya Fang) ； 陳凱偉(Kai-Wei Chen) ； 王德原(Der-Yuan Wang) ； 施養志(Daniel Yang-Chih Shih)

《食品藥物研究年報》 3期 (2012/12) Pp. 298-306

https://doi.org/10.6945/ARFDR.201212.0298

摘要

台灣地區為世界上B型肝炎帶原率高的流行區之一，政府自民國70年代起陸續投入大量人力與物力進行「加強肝炎防治計畫」，以改善國人肝炎防治的效果。由於B型肝炎表面抗原試劑常作為血品製造前端捐贈者之篩選，其產品品質對於國人用血安全有密切的相關性。前藥檢局曾於97年進行該品項之後市場調查，並發現分別在輸入及國產之中，各有一產品無法符合當時衛生署所公告之B型肝炎表面抗原試劑檢測靈敏度規定（≦ 0.5 ng/mL）。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下修該產品靈敏度至≦ 0.13 IU/mL，並繼續加強其品質把關，於100年進行第二次的後市場效能評估。由於人工操作產品之品質不佳風險較大，因此本計畫將以該類型產品為優先調查對象，以前藥檢局所製備的「B型肝炎表面抗原ad亞型國家標準品」與WHO國際標準品，針對目前市售之B型肝炎病毒表面抗原診斷試劑進行效能品質監測，以作為後續產品品質控管及製造廠品質管理之依據，並保障民眾健康與用血安全。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）抽樣產品進行試驗分析。源頭抽得3件人工操作品項（2張許可證），市售隨機抽樣抽得19件人工操作及自動化操作品項（8張許可證）。研究結果顯示，外觀標示部分，有2件產品（2張許可證）之外盒未有中文標示及衛署醫器字號。於本次抽得產品中，其中1件國產人工操作產品已於去年8月停產，其檢驗靈敏度不僅未符合目前國內公告之查驗登記審查準則（≦ 0.13 IU/mL），亦未符合過去≦ 0.5 ng/mL之靈敏度標準。上述不合格產品之檢驗結果皆已交轄區衛生局及本局醫粧組進行後續行政作業。系統性針對第三等級輸捐血篩檢用體外診斷試劑，進行全面性效能評估，除有效篩選出不良產品，並透過行政程序確保市售試劑品質外，更建立本局製備生物性國家標準品之最佳運用範例，作為日後進行其他市售診斷試劑效能評估之模式。

關鍵字

後市場調查 ； 靈敏度 ； B型肝炎表面抗原診斷試劑

並列摘要

Chronic HBV infection is endemic in Taiwan, where the carrier rate of hepatitis B surface antigen (HBsAg) in the general population is high. The public vaccination program of hepatitis B virus (HBV) was launched by Department of Health in Taiwan in 1984. Since HBsAg test kits are used as sensitive screening and accurate diagnostic assays, the analytical quality of such kits thus plays an important role in monitoring of the infection status and interpreting the long-term success of vaccination. Bureau of Food and Drug Analysis in Taiwan conducted a post-market performance survey of HBsAg kits in 2008, and found that two certain products failed to fulfill the criteria for the analytical sensitivity of ≦ 0.50 ng/mL required by Department of Health, Executive Yuan, Taiwan. This criterion was further revised from 0.50 ng/mL to 0.130 IU/mL in Taiwan in 2010, so this post-market performance survey of HBsAg kits was carried out again this year. Because the analytical quality of manually-operated HBsAg test kits has been found less precise than that of automated test kits according to the survey in 2008, the manually-operated HBsAg test kits were chosen to be targets in this study. Using both the National Standards (Taiwan Food and Drug Administration, TFDA) and the International Reference Standards (WHO) for HBsAg, the HBsAg test kits have been evaluated.Three manual kits from manufacturers or their authorized representatives and 19 randomly selected automated or manual kits from market have been collected with the assistance of local health personnel. We found that the labels and packaging of two certain products are not printed in Chinese language, and no registration numbers on the packages. The analytical sensitivity of a domestic-manufactured manually-operated kit, which has been out of production since last August, failed to fulfill either the criteria for the analytical sensitivity of ≦ 0.130 IU/mL or ≦ 0.50 ng/mL. The results of the products which failed to fulfill the criteria for labels, packaging, and analytical sensitivity have been reported to the local Departments of Health 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 assessed the effectiveness of the marked class III medical devices for HBsAg detection, but also reported the malfunction or failure of a device using the National Standards set by TFDA successfully.

並列關鍵字

post-market performance survey ； analytical sensitivity ； HBsAg test kits