亞培C型肝炎病毒負荷量檢驗套組

醫材分類

• B.4020分析特定試劑

醫器規格

# 4J86-70 、# 4J86-80、# 4J86-90 規格及標籤、說明書或包裝：詳如核定之中文說明書(原104年6月2日核定之標籤、說明書或包裝正本收回作廢)。

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適應症

本產品為體外反轉錄聚合酶連鎖反應（RT-PCR）分析，用於定量HCV感染個體之人類血清及血漿中的C型肝炎病毒核糖核酸（hepatitis C viral ribonucleic acid，HCV RNA）。本產品用於輔助管理接受抗病毒治療的HCV感染病患。本產品不可用於篩檢血液、血漿、血清或組織捐贈者的HCV，或作為確認是否存在HCV感染的診斷測試使用。

醫材資訊

主成分

# 4J86-70：Abbott RealTime HCV Calibrator Kit\n？ Abbott RealTime HCV Calibrator A and Abbott RealTime HCV Calibrator B：\nNoninfectious Armored RNA with HCV sequences in negative human plasma. Negative human plasma tested and found to be nonreative for HBsAg, HBV DNA, HCV RNA, HIV RNA, anti-HIV-1/HIV-2, and anti-HCV. # 4J86-90：Abbott RealTime HCV Amplification Reagent Kit\n？Abbott RealTime HCV Internal Control ：＜0.01% noninfectious Armored RNA with internal control sequences in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HCV RNA, HIV RNA, anti-HIV-1/HIV-2, and anti-HCV. \n？Abbott RealTime HCV Amplification Reagent Pack：1 bottle (0.141 mL) Thermostable rTth Polymerase Enzyme (2.9 to 3.5 Units/μL) in buffered solution, 1 bottle (1.10 mL) HCV Oligonucleotide Reagent. ＜0.1% synthetic oligonucleotides (4 primers, 2 probes), and ＜0.3% dNTPs in a buffered solution with a reference dye, 1 bottle (0.40 mL) Activation Reagent. 30mM manganese chloride solution. # 4J86-80：Abbott RealTime HCV Control Kit\n？Abbott RealTime HCV Negative Control：Negative human plasma tested and found to be nonreactive for HBsAg HBV DNA, HCV RNA, HIV RNA, anti-HIV-1/HIV-2, and anti-HCV. \n？Abbott RealTime HCV Low Positive Contorl and Abbott RealTime HCV High Positive Control：Noninfectious Armored RNA with HCV sequences in negative human plasma. Negative human plasma tested and found to be nonreactive for HBsAg, HBV DNA, HCV RNA, HIV RNA, anti-HIV-1/HIV-2, and anti-HCV.

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

2028/02/18

發證日期

2008/02/18

供應藥局

目前尚無登錄供應此品項的藥局資料。