內毒素檢測 QCL-1000 Endpoint Chromogenic LAL Assay Kit, mutliple vials close-up view
在製造無菌注射針劑及醫療器材時,需檢測熱原(Pyrogens),因為當熱原經血液進入人體時,會誘發一連串的免疫反應,造成發熱、休克,甚至引起器官代謝異常或死亡。而熱原的主要成分為內毒素(Endotoxin),由革蘭氏陰性菌外套膜的脂多糖(LPS)所組成。過去熱原檢測以兔熱源試驗法為主,但實驗動物的人力成本昂貴,且兔子免疫反應個體差異大,可能造成實驗結果不穩定。現多以細菌內毒素檢測法(Bacterial Endotoxins Test,BET)為主。細菌內毒素檢測法主要原理為鱟血變形細胞遇到內毒素會使血液凝集成膠狀,以此原理發展出不同套組試劑執行內毒素檢測。
Lonza 為內毒素試劑的領導品牌,而啟新生技為 Lonza 內毒素試劑之台灣唯一代理,符合藥典規範,值得信賴。
Lonza 內毒素試劑:
藥典方法 | 產品名稱 | 靈敏度 |
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凝膠法 Gel-Clot Technique | Pyrogent™ Gel Clot LAL Assay | 0.03 EU/mL 0.06 EU/ml 0.125 EU/ml 0.25 EU/ml |
動力濁度法 Kinetic Turbidimetric Assay | Pyrogent™-5000 Kinetic Turbidimetric LAL Assay | 0.01-100 EU/ml |
終點呈色法 Endpoint Chromogenic Assay | QCL-1000™ Endpoint Chromogent LAL Assay | 0.1-1 EU/ml |
動力呈色法 Kinetic Chromogenic Assay | Kinetic-QCL™ Kinetic Chromogent LAL Assay | 0.005 -50 EU/ml |
替代方法-rFC螢光法 rFC Endpoint Fluorescent Assay | PyroGene™ Recombinant Factor C Assay | 0.005-5 EU/ml |
Lonza 內毒素儀器及軟體:
產品 | Cat. NO. | 偵測範圍 | 規格 |
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ELx808™ Incubating Absorbance Plate Reader | 25-315S |
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PyroWave™ XM Fluorescence Reader | 25-345S |
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PyroTec™ Liquid Handling System | 25-601 25-602 25-603 |
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WinKQCL™ Endotoxin Detection and Analysis software | 25-501~25-505 | 符合21 CFR Part 11的內毒素計算軟體 |
Lonza 內毒素相關耗材:
產品 | Cat. NO. | 規格 | 備註 |
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Pyrogen-free Test Tubes | N201 | 含蓋,10╳75 mm | 內毒素含量低於0.005 EU/mL |
Pyrogen-free Test Tubes | N205 | 不含蓋,10╳75 mm | 內毒素含量低於0.005 EU/mL |
Pyrogen-free Test Tubes | N207 | 不含蓋,13╳100 mm | 內毒素含量低於0.005 EU/mL |
Sample Containers | 80-507L | 無熱原,含蓋玻璃瓶,10 mL,25/box | 內毒素含量低於0.005 EU/mL |
Sample Containers | 80-507U | 無熱原,含蓋玻璃瓶,10 mL,100/box | 內毒素含量低於0.005 EU/mL |
LAL Reagent Grade Multi-well Plates | 25-340 | 50/case | 內毒素含量低於0.0005 EU/mL,無抑制(干擾)因子 |
Eppendorf® 2–200 µL Biopur™ Pipette Tips | 25-415 | 2-200 μl,5 trays/pkg,96 tips/tray | 內毒素含量低於0.001 EU/mL |
Eppendorf® 2–300 µL Biopur™ Pipette Tips | 25-416 | 2-300 μl,5 trays/pkg,96 tips/tray | 內毒素含量低於0.001 EU/mL |
Eppendorf® 50–1000 µL Biopur™ Pipette Tips | 25-417 | 50-1000 μl,5 trays/pkg,96 tips/tray | 內毒素含量低於0.001 EU/mL |
LAL Reagent Reservoirs | 190035 | 10/pack | 內毒素含量低於0.005 EU/mL |
Aluminum Block with Lid | 25-038A | Heat block insert for 96-well plate | |
Aluminum Insert Block for Techne Dry Heat Block | BEF3503 | ||
Techne Dry Heat Block | FDB03DD | Digital, from 25°C to 100°C, requires 3 × BEF3503 | |
LAL Reagent Water | W50-640 | 30 mL | 內毒素含量低於0.005 EU/mL,保證PPC組別回收率達75-150% |
LAL Reagent Water | W50-100 | 100 mL | 內毒素含量低於0.005 EU/mL,保證PPC組別回收率達75-150% |
LAL Reagent Water | W50-500 | 500 mL | 內毒素含量低於0.005 EU/mL,保證PPC組別回收率達75-150% |
LAL Reagent Water | W50-1000 | 1000 mL | 內毒素含量低於0.005 EU/mL,保證PPC組別回收率達75-150% |
β-G-Blocker | N190 | 5 mL/vial,共5 vial | 內毒素含量低於0.005 EU/mL |
Pyrosperse™ Dispersing Agent | N188 | 5 mL/vial,共5 vial | |
MgCl2 10 mM Solution | S50-641 | 10 mM solution,1 vial | 內毒素含量低於0.005 EU/mL |
Tris Buffer 50 mM | S50-642 | 50 mM buffer,30 mL/vial,1 vial | 內毒素含量低於0.005 EU/mL |
Endotoxin, E. coli O55:B5 | 193783 | >1,250,000 EU/vial,5 vial | |
Endotoxin Challenge Vials™ | 192568 | >1,000 EU/vial,25 vial | |
USP Reference Standard Endotoxin | E700 | 10,000 EU/mL,1 vial |
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