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題 名 | Evaluation and Validation of Potency Testing Method for Live Rubella Virus Vaccine=德國麻疹活病毒疫苗效價試驗方法之確效評估 |
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作 者 | 王德原; 葉昇炎; 周清邦; 陳惠芳; 謝榮添; 林嘉伯; | 書刊名 | 藥物食品分析 |
卷 期 | 9:4 2001.12[民90.12] |
頁 次 | 頁183-190 |
分類號 | 418.293 |
關鍵詞 | 德國麻疹活病毒疫苗; 細胞病變; 確效分析; Cytopathic effect; Live rubella vaccine; Accuracy; Precision and validation; |
語 文 | 英文(English) |
中文摘要 | 一般而言,德國麻疹活病毒疫苗是利用病毒接種RK-13細胞產生離體細胞病變 (cytopathlc effect 、CPE)的方法來測定其疫苗效價。然而,利用此法進行效價試驗時,透過顯微鏡來判讀德國麻疹病毒在RK-13細胞上產生的CPE並不容易。因此,對於政府相關單位及疫苗製造廠的檢驗實驗室而言,為確保德國麻疹活病毒疫苗的品質,發展精確、快速且有效的效價試驗方法是非常重要的。在本研究中,我們以不同的細胞培養條件來評估14天培養期中可使RK-13細胞維持正常形態的環境,正對在不同病毒接種環境下獲致之德國麻疹活病毒疫苗效價試驗CPE結果進行確效分析,以期找出最佳之德國麻疹疫苗效價試驗的方法。試驗結果顯示,當RK-13細胞培養以含2%濃度胎牛血清之培養液及33℃溫度環境中培養,可在96孔細胞培養盤中維持14天的正常形態與細胞生理,此結果提供德國麻疹疫苗進行CPE效價試驗時穩定的細胞基質環境。此外,我們發現33℃的病毒接種培養溫度在配合前述細胞培養條件之下,可使德國麻疹疫苗效價試驗的CPE呈時間自10至14天提前至7至8天,且易於鏡檢判讀,而在經由FPLSD多重比較、單因子變方分析及pair-T檢定等統計方法進行確效分析後發現,唯有在33℃的病毒接種培養環境下所獲得的效價結果,才能達到最佳的再現性 (repeatability )、精密性 (accuracy) 與組間精確度 (intermediate precision)。 |
英文摘要 | The potency of live rubella virus vaccine is usually determined by the microtitration method using in vitro cytopathic effect (CPE) with rabbit kidney epithelial (RK-13) cell culture. However, it is difficult to identify the rubella viral CPE through microscopic examination. Therefore, developing a validated and accurate method for potency determination is important for the laboratories of the government and vaccine manufacturers to ensure the effectiveness of rubella vaccination. In this study, we evaluated different culture conditions of RK-13 cells for the potency test of live rubella virus vaccine. We found that the RK-13 cells with the initial plating number of 13,000 per well of 96-well cell culture plate, supplied with 2% fetal bovine serum (FBS) could form and maintain a normal monolayer for 14 days when incubated at 33°C. In addition, our results showed that the rubella viral CPEs are developed faster and simpler under 2% of serum concentration and at 33°C. The results of validation analysis finally confirmed that the culture condition with plating number of 13,000 cells/well, 2% of serum concentration, and 33°C incubating temperature achieve the most accurate and precise results for the CPE potency test of live rubella virus vaccine. |
本系統中英文摘要資訊取自各篇刊載內容。