供应现货WHO07/350可溯源凝血因子VIII国际标准物质Fa VIII
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The WHO 8th International Standard for Blood Coagulation Factor VIII:C,Concentrate, consists of glass ampoules, coded 07/350, containing aliquots of a freeze-dried concentrate of plasma derived Factor VIII,formulated with human albumin. This preparation was established by the Expert Committee on Biological Standardization of the World Health Organization in October 2009 and details of the preparation and value assignment are available in document WHO/BS/09.2117. This standard is primarily intended to be used to calibrate secondary and/or in-house working Factor VIII concentrate standards. WHO07/350
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. 可溯源凝血因子VIII国际标准物质Fa VIII
The concentrate standard was prepared from pooled therapeutic concentrates which were manufactured from pools of human plasma in which every donation as well as the pools were tested and found negative for HBsAg, anti-HIV 1 & 2, and anti-hepatitis C antibodies; in addition, the plasma pools were tested and found negative for hepatitis C RNA (NAT testing). The therapeutic concentrates had also undergone a virus inactivation procedure. The concentrate standard contains human albumin, clinical grade, which was also prepared from pools of human plasma in which every donation was tested and found negative for HBsAg, anti-HIV 1 and 2, and anti-hepatitis C antibodies.
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.
世界卫生组织第八版凝血因子VIII:C浓缩物国际标准由编号为07/350的玻璃安瓿组成，安瓿中含有用人白蛋白配制的血浆衍生因子VIII冻干浓缩物的小份。该制剂由世界卫生组织生物标准化专家委员会于2009年10月制定，制剂和赋值的详细信息见世界卫生组织/英国标准化局/09.2117号文件。本标准主要用于校准二级和/或内部工作因子VIII浓缩物标准。
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材料，其最终产物或来源材料经过测试，发现HBsAg、抗HIV和HCV RNA呈阴性。
浓缩物标准品是由汇集的治疗浓缩物制备的，这些浓缩物是由人血浆池制造的，在人血浆池中对每一次捐献和血浆池进行测试，发现HBsAg、抗HIV 1和2以及抗丙型肝炎抗体呈阴性；此外，对血浆池进行了检测，发现丙型肝炎RNA（NAT检测）呈阴性。治疗浓缩物也经过了病毒灭活程序。浓缩物标准含有临床级人类白蛋白，也是从人类血浆池中制备的，在血浆池中对每一次捐献进行了检测，发现HBsAg、抗HIV 1和2以及抗丙型肝炎抗体呈阴性。
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