聯信嗜T型淋巴病毒1型和2型抗體酵素免疫診斷試劑盒
UBI HTLV-I/II EIA

適應症
酵素免疫分析法定性測試人體血清或血漿內之嗜T型淋巴球病毒I型、II型抗體。 
劑型
 
包裝
 
許可證字號
衛部成製字第000117號 
註銷狀態
1 
註銷日期
2004-03-12  
註銷理由
824,823 
有效日期
2007-04-03  
發證日期
2002-04-03  
許可證種類
04 
中文品名
聯信嗜T型淋巴病毒1型和2型抗體酵素免疫診斷試劑盒 
英文品名
UBI HTLV-I/II EIA 
藥品類別
 
申請商名稱
永信藥品工業股份有限公司  
申請商地址
台中縣大甲鎮中山路一段１１９１號 
通關簽審文件編號
DHA00900011705 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
永信藥品工業股份有限公司台中幼獅廠 台中縣大甲鎮日南里工九路２７號 TW
成份表
處方標示 成分名稱 含量 單位
1 1.1ML HTLV-1強陽性對照(HTLV-1 STRONGLY REACTIVE CONTROL):1瓶 INACTIVATED NORMAL HUMAN SERUM CONTAINING HTLV-I ANTIBODIES. NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN AND ANTIBODIES TO HIV-1/2. CONTAINS PRESERVATIVES:0.1% SODIUM AZIDE AND 0.01% GENTAMICIN. STORE AT 2-8 C.
1 2.1ML HTLV-II 弱陽性對照(HTLV-II WEAKLY REACTIVE CONTROL):1 瓶 INACTIVATED HUMAN SERUM CONTAINING HTLV-II ANTIBODIES, SPECIFIC FOR PEPTIDE ANTIGERS. NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN AND AANTIBODIES TO HIV-1/2 CONTAINS PRESERVATIVES: 0.1% SODIM AZIDE AND 0.01% GENTAMICIN. STORE AT 2~8°C.
1 3.1 ML 陰性對照(NON-REACTIVE CONTROL):1瓶 INACTIVATED NORMAL HUMAN SERUM, WHICH IS NON-REACTIVE FOR HEPATITIS B SURFACE ANTIGEN, ANTIBODIES TO HIV-1/2, HTLV-I/IIAND HEPATITIS C VIRUS. CONTAINS PRESERVATIVES: 0.1% SODIM AZIDE AND 0.01% GENTAMICIN. STORE AT 2~8°C
1 4.45ML 樣品稀釋液(HTLV-I/II SPECIMEN DILUENT):1瓶 BUFFERED SALT SOLUTION CONTAINING HEAT-TREATED NORMAL GOAT SERUM, CASEIN AND 0.01% GENTAMICIN AD PRESERVATIVES. STORE AT 2~8°C
1 5.30ML 酵素結合物稀釋液 (CONJUGATE DILUENT):1瓶 PHOSPHATE BUFFERED SALINE SOLUTION CONTAINING SURFACTANT AND HEAT-TREATED NORMAL GOAT SERUM, WITH 0.01% GENTAMICIN AS A PRESERVATIVE. STORE AT 2~8°C
1 6.25ML TMB 受質溶液(TMB SUBSTRATE SOLUTON):1瓶3,3',5,5'-TETRAMETHYLBENZIDINE (TMB) DISSOLVED IN CITRATE-PHOSPHATE BUFFER AND H2O2 SOLUTION. STORE AT 2~8°C.
1 7.25ML 終止液 (STOP SOLUTION):1瓶 DILUTED SULFURIC ACID SOLUTION (1.0M H2SO4). STORE AT 2~30°C
1 8.150ML 濃縮洗滌液 (WASH BUFFER CONCENTRATE, 25X):1瓶 A 25 X CONCENTRATE OF PHOSPHATE BUFFERED SALINE WITH SURFACTANT. STORE AT 2~30°C
1 9.0.4 ML HTLV-I/II 酵素結合物 (HTLV-I/II HRP-CONJUGATE):1 瓶 HORSERADISH PERODIDASE-CONJUGATED GOAT ANTI-HUMAN IGG ANTIBODIES, WITH 0.01 % GENTAMICIN AND 0.05 % 4-DIMETHYLAMINOANTIPYRINE. STORE AT 2~8°C
1 10.96孔 HTLV-I/II 反應盤 (HTLV-I/II PLATE, 96 WELLS):2 盤 EACH PLATE WELL CONTAINS ADSORBED SYNTHETIC HTLV-I/II PEPTIDES. STORE AT 2-8°C SEAIED WITH DESICCANT.