- 期刊
C型肝炎抗體診斷試劑效能評估調查研究
Post-market Surveillance for the Performance of Anti-HCV In Vitro Diagnostic Devices
摘要
C型肝炎為常見的輸血感染疾病，雖然其症狀並不嚴重，但有70%的感染者會轉成慢性C型肝炎，並造成肝硬化甚至產生肝細胞癌。C型肝炎盛行區域遍及全球，於台灣因輸血而造成肝炎的患者，有69%為感染C型肝炎。自1992年7月將C型肝炎篩檢納入血液篩檢項目，已幾乎無輸血後C型肝炎病毒感染之發生。由於C型肝炎尚無疫苗可以防治，防疫上僅能依靠抗C型肝炎免疫診斷試劑進行篩檢，因此抗C型肝炎病毒抗體診斷試劑的品質，與是否能有效控制輸血後C型肝炎感染風險有密切關聯。 有鑑於97年度執行「B型肝炎表面抗原診斷試劑效能評估」，發現部分產品未達衛生署公告之標準，故於98年度針對衛生署核准之抗C型肝炎病毒抗體體外診斷試劑進行效能評估調查研究；檢體係購自國內製造廠與代理商，並對不同生產批次產品利用國內、外C型肝炎血清標準品以抗原抗體反應試臉進行重複檢驗分析。結果顯示，10種產品中除2種國產試劑外，其餘產品皆可有效判別本研究計畫所使用之血清標準品。本計畫結果將做為產品後續管理參考，以有效監測該類試劑品質與效能，保障國人用血安全。
並列摘要
Hepatitis C virus (HCV) infection is the most common chronic blood-borne viral infection in the world. Most of these patients are chronically infected and might not be aware of their infection because they are not clinically ill. Infected persons serve as a source of transmission to others and are at risk for chronic liver disease or other HCV-related chronic diseases following initial infection. In Taiwan, lots of people were infected by HCV due to the blood reception. The anti-HCV in vitro diagnostic devices have been introduced for screening the blood since 1992, and thus reducing the infection of HCV. So the performance of anti-HCV in vitro diagnostic devices is extremely important to maintain the safety of blood usage. Our study surveyed the performance of anti-HCV in vitro diagnostic devices which is approved to market by DOH in Taiwan. The study used HCV serum standards to survey these products. The data indicated that most of the products can identify the reference standards and panels except 2 native products. This study will help us improve the blood usage safety and will serve as the reference for further post-market surveillance.