適應症
酵素免疫分析法定性測試人類血清或血漿中之人類嗜T淋巴球病毒第一型及第二型抗體,篩選用.  
劑型
 
包裝
96 or 480 wells/盒裝 
許可證字號
衛部藥製字第011739號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2027-08-12  
發證日期
2005-08-08  
許可證種類
09 
中文品名
亞培”妙芮絲”人類嗜T淋巴球病毒第一型及第二型抗體檢驗試劑 
英文品名
Murex HTLV I+II 
藥品類別
B 血液學及病理學用裝置 
申請商地址
臺北市中山區民生東路3段49號5樓、6樓及51號6樓 
通關簽審文件編號
DHA00601173900 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN S.P.A. UK BRANCH Central Road, Dartford, DA1 5LR, United Kingdom GB
成份表
處方標示 成分名稱 含量 單位
1 1.antigen coated wells One plate or five plates of 96 wells coated with HTLV-I and II Antigens.2.Sample diluent One bottle of containing buffer and detergents. Contains 0.05 Bronidox preservative.3.Negative control One bottle of containing normal human serum non-reactive for HBsAg and antibody to HIV-1, HIV-2, HCV and HTLV-1 and HTLV-11 Diluted in a bovine protein buffer. Contains 0.05 Bronidox preservative.4.Anti-HTLV positive control One bottle containing inactivated human serum containing antibodies to HTLV but negative for hepatitis B surface antigen (HBsAg) and negative for antibodies to HIV-1 and HIV-2, diluted in a buffer containing bovine protein. Contains 0.05% Bronidox preservative.5.Conjugate.One bottle containing HTLV antigens conjugated to horseradishPeroxidase and freeze dried.
1 6.Conjugate diluent one bottle containing a red solution consisting of buffer, bovine protein and detergent. Contains 0.05% Bronidox preservative.7.Substrate diluentone bottle containing a colourless solution of tri-sodium, citrate and hydrogen peroxide.8.Substrate concentrate one bottle containing 3,3’,5,5’-tetramethylbenzidine (TMB) and stabilizers in a pink solution.9.Wash fluid one bottle containing 125ml of 20 times working strength Glycine/Borate wash fluid. Contains 0.2% Bronidox preservative.