適應症
使用化學冷光免疫分析(CLIA)技術以定量測定直接對抗水痘病毒的免疫球蛋白G類抗體於人體血清或血漿檢體。此檢測分析僅能以禮亞尚分析儀使用。  
劑型
 
包裝
# 310850:50 tests, # 310851:0.7 ml x 2 
許可證字號
衛部藥製字第019953號 
註銷狀態
註銷日期
 
註銷理由
 
有效日期
2029-02-25  
發證日期
2009-02-25  
許可證種類
09 
中文品名
禮亞尚水痘帶狀疱疹免疫球蛋白 G 檢測試劑 
英文品名
LIAISON VZV IgG 
藥品類別
A 臨床化學及臨床毒理學 
申請商地址
新北市汐止區福德三路369號12樓 
通關簽審文件編號
DHA00601995303 
資料更新時間
 
製造商
名稱 廠址 公司地址 國別 製程
DIASORIN ITALIA S.P.A. VIA CRESCENTINO SNC, 13040 SALUGGIA (VC), ITALY IT
成份表
處方標示 成分名稱 含量 單位
1 檢測試劑:\n1.Magnetic particles(1.3mL):Magnetic particles coated with varcella-zoster virus antigen (partially purified extract of infected cell cultures ROD strain), BSA, PBS buffer, <1.0% sodium azide.\n2.Calibrator 1(2.7mL):Human serum/plasma containing low varicella-zoster virus IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye. The calibrator concentrations (mIU/mL) are referenced to WHO InternationalStandard Preparation(W1044).\n3.Calibrator 2(2.7mL):Human serum/plasma containing low varicella-zoster virus IgG levels, BSA, phosphate buffer, preservatives, an inert yellow dye. The calibrator concentrations (mIU/mL) are referenced to WHO InternationalStandard Preparation(W1044).\n4.Specimen diluents(28mL):BSA, phosphate buffer, preservatives, an inert yellow dye.\n5.Conjugate(13mL):Mouse monoclonal antibodies to human IgG conjugated to an isoluminol derivative, BSA, PBS buffer, preservatives
1 品管組:\nNegative control(2 x0.7mL):Human serum/ plasma stabilized in TRIS-NaCL buffer, non-reactive for VZV IgG antibodies, preservatives.\nPositive control(2 x0.7mL):Human serum/ plasma reactive for VZV IgG antibodies,stabilized in TRIS-NaCl buffer, preservatives, an inert yellow dye.