羅氏 ”達可” B型肝炎病毒核酸檢驗試劑套組
COBAS TaqMan HBV Test

適應症
COBAS TaqMan B型肝炎病毒檢驗試劑乃配合高純度系統 (The High Pure System HPS) 來作體外核酸增幅的檢驗，利用高純度病毒核酸套組來手動製備檢體以及COBAS TaqMan 48分析儀來自動增幅和偵測人類血清或血漿中B型肝炎病毒 (HBV DNA) 的含量。  
劑型
 
包裝
#03500756: 48 Tests, #03502295: 48 Tests 
許可證字號
衛部藥製字第019397號 
註銷狀態
0 
註銷日期
 
註銷理由
 
有效日期
2023-06-27  
發證日期
2008-06-27  
許可證種類
09 
中文品名
羅氏 ”達可” B型肝炎病毒核酸檢驗試劑套組 
英文品名
COBAS TaqMan HBV Test 
藥品類別
B 血液學及病理學裝置 
申請商名稱
台灣羅氏醫療診斷設備股份有限公司  
申請商地址
臺北市中山區民權東路3段2號10樓 
通關簽審文件編號
DHA00601939702 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
ROCHE MOLECULAR SYSTEMS, INC. 1080 US HIGHWAY 202 SOUTH, BRANCHBURG, NJ 08876 USA US
成份表
處方標示 成分名稱 含量 單位
1 High Pure System Viral Nucleic Acid Kit: 48 Tests\nLYS (Lysis/Binding Buffer): Tris, 52% Guanidine-HCl, <1% Urea, 20% Triton X-100 2 x 25 mL; CAR (RNA, lyophilized): 2 x 2 mg; PK (Proteinase K, lyophilized): 99% Proteinase K, lyophilized 2 x 100 mg; IRB (Inhibitor Removal Buffer): Tris, 65% Guanidine-HCl (add 20 mL Ethanol) 1 x 33 mL; WASH (Wash buffer): Tris, NaCl (add 80 mL Ethanol) 1 x 20 mL; ELB (Elution Buffer) 1 x 30 mL; RS (High Pure System Viral Nucleic Acid Rack Set): Lysis Rack, Filter Tube Rack with affixed Waste Rack, Elution Rack, Cover Rack, Grippers 4 x each; WR (High Pure System Viral Nucleic Acid Waste Rack) 8 x each.
1 COBAS TaqMan HBV Test: 48 Tests\nSpecimen Preparation and Control Reagents: HBV QS (COBAS TaqMan HBV Quantitation Standard): Tris-HCl buffer, EDTA, <0.001% linearized, double stranded plasmid DNA containing an insert, Amaranth dye, <0.005% Poly rA RNA (synthetic), 0.05% Sodium azide 2 x 1.0 mL; HBV H(+)C [HBV High (+) Control]: <0.001% linearized, double stranded plasmid DNA containing HBV sequences, Negative Human Plasma, 0.1% ProClin 300 2 x 1.0 mL; HBV L (+)C [HBV Low (+) Control]: <0.001% linearized, double stranded plasmid DNA containing HBV sequences, Negative Human Plasma, 0.1% ProClin 300 2 x 1.0 mL; CTM (-)C [COBAS TaqMan Negative Control (Human Plasma)]: Negative Human Plasma, 0.1% ProClin 3004 x 1.0 mL.
1 Amplification and Detection Reagents: HBV MMX (COBAS TaqMan HBV Master Mix) 2 x 24 Tests, 2 x 1.4 mL: Tricine buffer, Potassium hydroxide, Potassium acetate, Glycerol, <0.001% dATP, dCTP, dGTP, dUTP, <0.001% Upstream and downstream primers to the Pre-Core/Core region of HBV, <0.001% Fluorescent-labeled oligonucleotide probes specific for HBV and the HBV Quantitation Standard, <0.001% Oligonucleotide aptamer, <0.05% Z05 DNA Polymerase (microbial), <0.1% AmpErase (uracil-N-glycosylase) enzyme (microbial), 0.09% Sodium azide; CTM Mn2+ (COBAS TaqMan Manganese Solution) 2 24 Tests, 2 x 1.0 mL: <1.2% Manganese acetate, Glacial acetic acid, 0.09% Sodium azide.