血液類病原標準品安定性試驗   全文下載

Stability Analysis of National Standards for Blood-Derived Pathogen

高風險第三等級體外診斷醫療器材，除須於上市前進行查驗登記檢驗外，並須藉由不定期監測調查上市後產品，以確保品質效能。因應前述檢驗需求，衛生福利部食品藥物管理署（下稱食藥署）已建立病毒類核酸標準品共計27項，並自93年起對外供應HBV、HCV、B19以及SARS-CoV-2等體外診斷醫療器材品質管理用之抗血清或核酸標準品，協助促進國內生技產業之發展。
食藥署遵循WHO政策，以不設定標準品效期為原則，若標準品評估後不適用將下架，故為維持標準品之公信力，本年度優先挑選血液類病原之B19、HBV、HCV以及HIV-1等4類病毒核酸國家與工作標準品（10項已對外供應之國家/工作標準品、4項未對外供應之國家/工作標準品共14項）進行安定性評估，透過與國際標準品比對確認國家/標準品目前病毒核酸含量，並以t-test與原始病毒核酸含量進行統計分析。目前14項標準品已全數評估完畢，t-test之p-value皆在0.05以上，無顯著差異，保存狀況良好可繼續使用。後續將持續監測國家/工作標準品病毒核酸含量，並針對濃度降低較快之標準品種類導入冷凍乾燥技術，強化我國生物性國家標準品之可信度，協助促進國內生技產業之發展，守護國人健康。

Registration inspection before market entry and periodic monitoring after release are required for Class III high-risk in vitro diagnostic medical devices to ensure quality and performance. In response to these inspection requirements, Taiwan Food and Drug Administration (TFDA) has established 27 nucleic acid virus standards. Since 1993, antiserum and nucleic acid standards for quality management of in vitro diagnostic medical devices, such as HBV, HCV, B19, and SARS-CoV-2, have been provided to the public, supporting the development of the domestic biotechnology industry. Basically, TFDA follows WHO’s policy, which is not setting an expiration date of the standard. If the standard is no longer applicable, it will be withdrawn or replaced. In order to maintain the credibility of the standards, we re-evaluate the concentrations of four types of national/working standards, including B19, HBV, HCV and HIV-1. We analyze the current concentrations of these standards by calibrating them against international standards and evaluate the differences between current and original concentrations using a t-test. All 14 standards from these four types have been assessed. The p-values of t-test are all above 0.05, meeting the internal criteria. In the future, we will continue monitoring the concentrations of standards and introduce freezedrying technology for those whose concentrations drop rapidly. This will strengthen the credibility and calibration accuracy of biological national standards, promote the development of biotechnology industry, and protect public health in Taiwan.