
供应WHO16/364可溯源前激肽释放酶激活剂国际标准物质PKA
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Prekallikrein Activator (PKA), also known as activated FXII or activated Hageman Factor, is a contaminant in human albumin solutions and immunoglobulin solutions prepared from fractionated plasma. It is known that adverse events, including vasodilation and hypotension, may occur where albumin solutions are contaminated with significant levels of PKA and are infused into patients. This is of special concern since albumin may be administered as a plasma expander to counter hypovolemia and hence the treatment may exacerbate the existing problem. Limits are set on the maximum level of PKA allowed in plasma and assays for PKA are standardised using an International Standard (IS). The current 3rd IS for PKA replaces the 2nd IS (02/168). The 3rd IS is a freeze dried preparation of 20 % albumin containing a significant level of PKA. WHO16/364
This preparation is not for administration to humans or animals in the human food chain.The preparation contains material of human origin, and either the final product or the source materials, from which it is derived, have been tested and found negative for HBsAg, anti-HIV and HCV RNA. As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures should include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts. 可溯源前激肽释放酶激活剂国际标准物质PKA
前激肽释放酶激活剂(PKA),也称为活化的FXII或活化的哈格曼因子,是从分级血浆制备的人白蛋白溶液和免疫球蛋白溶液中的污染物。众所周知,当白蛋白溶液被大量PKA污染并输注到患者体内时,可能会发生包括血管舒张和低血压在内的不良事件。这是一个特别值得关注的问题,因为白蛋白可以作为血浆扩张器来对抗低血容量,因此这种治疗可能会加剧现有的问题。对血浆中允许的PKA的最高水平设定了限制,并使用国际标准(IS)对PKA的测定进行标准化。目前PKA的第三个IS取代了第二个IS(02/168)。第三个IS是冷冻干燥的20%白蛋白制剂,含有显著水平的PKA。
该制剂不适用于人类或人类食物链中的动物。该制剂含有人类来源的物质,其最终产物或来源物质已经检测,HBsAg、抗-HIV和HCV RNA呈阴性。与所有生物来源的材料一样,这种制剂应被视为对健康有潜在危害。应根据您自己实验室的安全程序使用和丢弃它。此类安全程序应包括佩戴防护手套和避免产生气溶胶。打开安瓿或小瓶时应小心,以避免割伤。