台灣地區市售C型肝炎抗體檢驗試劑之評估

THE EVALUATION OF commercial Anti-HCV DIAGNOSTIC KITS IN TAIWAN

C型肝炎抗體檢驗試劑為檢測C型肝炎之重要工具，目前台灣地區上市之C型肝炎抗體檢驗試劑已有多種，而各廠牌間之評估報告闕如，本報告即針對目前已在國內上市之該檢驗試劑作初步評估。自民國八十三年十二月至八十四年一月間，分別於台灣北、中、南區大型醫院及捐血中心抽購五種不同廠牌之C型肝炎抗體酵素免疫分析法檢驗試劑共六件，並依據各廠牌所附之操作手冊進行檢測。各廠牌檢驗試劑所需檢測時間分別為45~150分鐘，其陰性對照血清之組內再現性為1l.81%~22.24%；陽性對照血清為3.05%~9.75%。在靈敏度方面有兩種廠牌較佳，但特異性方面各廠牌間並無顯著差異。

Anti-HCV diagnostic kit are routinely used to determine the prevalennce of antibody to HCV in the populations of blood donors or in blood preparations. The aim of this study was to evaluate the commercial anti-HCV diagnostic kits used in Taiwan. Six representitive commercial kits of five Manufactorers purchased from hospital dispenseries or blood donor centers, Antibody detection was performed according to the manufacturer's instructions. The process time for the commercial kits ranged from 45 minutes to 150 minutes. The within-run reproducibility of the negative control sera varied from 11.81% to 22.24% and the positive control sera ranged from 3.05% to 9.75%.Among the kits tested, the products from two manufacturers exhibited greater sensitivity, compared to the other three. However, all kits examined yielded the same specificity.