羅氏全自動達可愛滋病毒量核酸檢驗套組第2代

🩺 醫材

COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0

衛署醫器輸字第021921號

醫材分類

第 3 等級

B.4020分析特定試劑

醫器規格

48 Tests P/N: 05212294 190

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適應症

利用體外核酸增幅試驗，定量檢測人類血漿（EDTA血漿）中之第一型人類免疫缺乏病毒（HIV-1）之RNA含量。

醫材資訊

主成分: CAP/CTM Mn2+ 1 x 19.8 mL\n(CAP/CTM Manganese Solution)\n< 0.5% Manganese acetate\nGlacial acetic acid\n0.09% Sodium azide HIV-1 L(+)C, v2.0 4 x 1.0 mL\n(HIV-1 Low Positive Control, v2.0)\n< 0.001% Armored HIV-1 RNA construct containing\nHIV-1 sequences.\nNegative Human Plasma\n0.1% ProClin® 300 preservative HIV-1 QS 1 x 3.6 mL\n(HIV-1 Quantitation Standard)\nTris-HCl buffer\nEDTA\n< 0.005% Poly rA RNA (synthetic)\n< 0.001% Armored HIV-1 RNA construct containing\nHIV-1 primer binding sequences and a unique\nprobe binding region\n0.05% Sodium azide HIV-1 MMX 1 x 2.5 mL\n(HIV-1 Master Mix)\nTricine buffer\nPotassium acetate\nPotassium hydroxide\n20% Dimethylsulfoxide\nGlycerol\n< 0.04% dATP, dCTP, dGTP, dUTP, dTTP\n< 0.003% Upstream and downstream primers to the\ngag and the LTR region of HIV-1\n< 0.003% Oligonucleotide aptamer\n< 0.003% Fluorescent-labeled oligonucleotide probes\nspecific for HIV-1 and the HIV-1 Quantitation\nStandard\n< 0.05% Z05 DNA Polymerase (microbial)\n< 0.1% AmpErase (uracil-N-glycosylase) enzyme\n(microbial)\n0.09% Sodium azide EB 1 x 7.0 mL\n(Elution Buffer)\nTris-base buffer\n0.2% Methylparaben \n HIV-1 v2.0 CS3 1 x 48 Tests\nHIV-1 Multi-Reagent Cassette containing:\nPase \n(Proteinase Solution)\nTris buffer \n< 0.05% EDTA \nCalcium chloride \nCalcium acetate \n≤7.8% Proteinase \nGlycerol 1 x 3.8 mL\n HIV-1 v2.0 CS1 1 x 48 Tests\n(HIV-1 Magnetic Glass Particles Reagent Cassette) \nMagnetic glass particles \n93% Isopropanol \n COBAS® AmpliPrep/COBAS® TaqMan® 48 Tests\nHIV-1 Test, v2.0\n (P/N: 05212294 190) \n HIV-1 v2.0 CS2 1 x 48 Tests\n(HIV-1 Lysis Reagent Cassette)\nSodium citrate dehydrate \n42.5% Guanidine thiocyanate \n< 14% Polydocanol \n0.9% Dithiothreitol\n CTM (–) C 4 x 1.0 mL\n[COBAS® TaqMan® Negative Control (Human Plasma)]\nNegative Human Plasma\n0.1% ProClin® 300 preservative HIV-1 H(+)C, v2.0 4 x 1.0 mL\n(HIV-1 High Positive Control, v2.0)\n< 0.001% Armored HIV-1 RNA construct containing\nHIV-1 sequences \nNegative Human Plasma\n0.1% ProClin® 300 preservative HIV-1 v2.0 CS4 1 x 48 Tests\nHIV-1 Test-Specific Reagent Cassette containing: \n
製造商: ROCHE MOLECULAR SYSTEMS, INC.
製造國: US
申請商: 台灣羅氏醫療診斷設備股份有限公司
有效日期: 2025/12/07
發證日期: 2010/12/07

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