產(chǎn)品英文名稱：PYROGENT? Gel Clot LAL Single Test Vials
產(chǎn)品中文名稱：PYROGENT?鱟變形細(xì)胞裂解物(LAL)凝膠法單一檢測(cè)試劑盒
PYROGENT? LAL 凝膠法單一檢測(cè)試劑盒 產(chǎn)品介紹：
PYROGENT? Gel Clot LAL Single Test Vial kit 由25個(gè)無(wú)熱原檢測(cè)安瓿小瓶組成，檢測(cè)小瓶中含有凍干的鱟變形細(xì)胞裂解物（LAL）。LAL檢測(cè)是一種對(duì)于存在的革蘭氏陰性細(xì)菌(G–)內(nèi)毒素的定性檢測(cè)。LAL內(nèi)含能被微量G–細(xì)菌內(nèi)毒素激活的凝固酶原（Proclotting enzyme）和凝固蛋白原（Coagulogen），適宜條件下細(xì)菌內(nèi)毒素激活鱟試劑中的凝固酶原，發(fā)生凝集反應(yīng)形成凝膠，如果沒(méi)有內(nèi)毒素存在則不形成凝膠。檢測(cè)方法簡(jiǎn)單，只要在安瓿瓶中添加250μl樣品或?qū)φ掌?，適當(dāng)溫育一段時(shí)間（37℃，1小時(shí)）就能得到檢測(cè)結(jié)果(具體檢測(cè)方法參照說(shuō)明書(shū))。無(wú)需頻繁移液，適合微量樣品檢測(cè)。The PYROGENT? Gel Clot LAL Single Test Vial kit 靈敏度為0.125 EU/ml。每個(gè)試劑盒包含25個(gè)檢測(cè)小瓶。試劑盒不含有對(duì)照用標(biāo)準(zhǔn)內(nèi)毒素。產(chǎn)品主要應(yīng)用于人或動(dòng)物注射藥物終產(chǎn)品體外內(nèi)毒素檢測(cè)，生物制品和醫(yī)療用具等的內(nèi)毒素檢測(cè)。產(chǎn)品不能用于臨床樣品內(nèi)毒素檢測(cè)，也不能輔助人類(lèi)疾病診斷。
注意事項(xiàng)：
? 本品為體外診斷試劑，嚴(yán)禁用于人體內(nèi)毒素檢測(cè)
? 本品用于藥品的G-細(xì)菌內(nèi)毒素檢測(cè)時(shí)，應(yīng)遵循USP藥典細(xì)菌內(nèi)毒素檢測(cè)法的規(guī)定
? 使用安瓿包裝的鱟試劑在開(kāi)啟時(shí)，應(yīng)防止玻璃屑落入瓶?jī)?nèi)，開(kāi)啟安瓿后應(yīng)馬上使用
PYROGENT? Gel Clot LAL Single Test Vials英文介紹：
This product is intended as an In Vitro end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. This product is not intended for the detection of endotoxin in clinical samples or as an aid in the diagnosis of human disease. The Limulus Amebocyte Lysate (LAL) test is a qualitative test for Gram-negative bacterial endotoxin. Limulus Amebocyte Lysate as supplied is to be reconstituted with the solution being tested. After incubation, and in the presence of endotoxin, gelation occurs; in the absence of endotoxin, gelation does not occur.
In December, 1987, the United States Food and Drug Administration (FDA) published the “Guideline on Validation of the Limulus Amebocyte Lysate Test As an End-product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices”10. This guideline outlines those procedures which the FDA considers necessary for: 1) establishing endotoxin limits for pharmaceuticals and medical devices, 2) validating the use of LAL as an endproduct endotoxin test, and 3) developing a routine testing protocol.
訂購(gòu)信息：
N183-06(Cat#)? PYROGENT? Gel Clot LAL??? 80tests(size)??? 0.06EU/ml(Sensitivity)
N186???????????????? Endotoxin(E.coli) for Gel Clot Assays??? 5vials(size)
S50-642??????????? Tris Buffer??? 30ml vial(size)????? 50mM Solution(Comments)??? 2-8℃(storage)
W50-100???????????LAL Reagent Water??? 100ml??? <0.005EU/ml??? 15-30℃(storage)
