亞培 B 型肝炎病毒量檢驗套組

醫材分類

• B.4020分析特定試劑

醫器規格

# 2G34-70, # 2G34-80, # 2G34-90 變更規格、標籤仿單變更為：詳如中文仿單核定本（原101年1月13日仿單標籤核定本正本收回作廢）。

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適應症

本產品為體外聚合酶連鎖反應(PCR)分析，用於定量HBV感染個體之人類血漿或血清中的B型肝炎病毒(Hepatitis B Virus，HBV) DNA。本產品用於搭配臨床表現及其他實驗室標記以作為疾病預後的指標，以及用於透過測量血漿或血清HBV DNA濃度變化來輔助評估病毒對抗病毒治療的反應。本產品不可作為HBV篩檢測試，或作為確認是否存在HBV感染的診斷測試使用。

醫材資訊

主成分

2. Abbott RealTime HBV Amplification Reagent Pack (List No. 2G34): 4 packs, 24 tests/pack\n1 bottle (0.078 mL) Amplitaq Gold Enzyme (5.4 to 5.9 Units/μL) in a buffered solution with stabilizers.\n1 bottle (0.917 mL) HBV Oligonucleotide Reagent. Less than 0.1% synthetic oligonucleotides (4 primers and 3 probes), and less than 0.2% dNTPs in a buffered solution with a reference dye. Preservatives: Sodium azide and 0.15% ProClin 950.\n1 bottle (0.778 mL) Activation Reagent. 38 mM magnesium chloride in a buffered solution. Preservatives: Sodium azide and 0.15% ProClin 950. Abbott RealTime HBV Amplification Reagent Kit (List No. 2G34-90)\n1. Abbott RealTime HBV Internal Control (List No. 2G34Y): 4 vials, 0.2 mL per vial\nLess than 0.01% noninfectious linearized DNA plasmid in a buffer solution.\nPreservatives: Sodium azide and 0.15% ProClin® 950. Abbott RealTime HBV Control Kit (List No. 2G34-80)\n1. Abbott RealTime HBV Negative Control (List No. 2G34Z): 8 vials, 1.3 mL per vial\nNegative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950. 3. Abbott RealTime HBV High Positive Control (List No. 2G34X): 8 vials, 1.3 mL per vial\nHeat-inactivated plasma reactive for HBV DNA in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950. 2. Abbott RealTime HBV Low Positive Control (List No. 2G34W): 8 vials, 1.3 mL per vial\nHeat-inactivated plasma reactive for HBV DNA in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HIV RNA, HCV RNA, anti-HIV-1/HIV-2, and anti-HCV. Preservatives: 0.1% ProClin 300 and 0.15% ProClin 950. 2. Abbott RealTime HBV Calibrator B (List No. 2G34B): 12 vials, 1.3 mL per vial\nLess than 0.01% noninfectious linearized HBV DNA plasmid in a buffer solution. Preservatives: Sodium azide and 0.15% ProClin 950. Abbott RealTime HBV Calibrator Kit (List No. 2G34-70)\n1. Abbott RealTime HBV Calibrator A (List No. 2G34A): 12 vials, 1.3 mL per vial\nLess than 0.01% noninfectious linearized HBV DNA plasmid in a buffer solution. Preservatives: Sodium azide and 0.15% ProClin 950.

製造商

ABBOTT MOLECULAR INC.

製造國

US

申請商

美商亞培股份有限公司台灣分公司

有效日期

2029/06/23

發證日期

2009/06/23

供應藥局

目前尚無登錄供應此品項的藥局資料。