供应NIBSC97/562人重组凝血因子IXa国际标准物质
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The potency of the Standard was determined by International Collaborative Study and found to be 10000 IU per ampoule (1) in comparison with the 2nd International Standard for tissue plasminogen activator (86/670), which is from melanoma cell culture (2). The Standard was established by the Expert Committee on Biological Standardisation of the World Health Organisation (WHO) in October 2000. Results from the International Collaborative Study suggest that the 3rd International Standard for tissue plasminogen activator (98/714) is a suitable standard for the melanoma cell-derived enzyme and the recombinant enzyme, and may be suitable for assaying tissue plasminogen activator from other sources (1). The potency of 10000 IU per ampoule for the 3rd International Standard for tissue plasminogen activator (98/714) was assigned using fibrin-based assay methods. Caution is advised when interpreting results using alternative assay methods. This Standard is intended for use as an activity standard in enzymatic assays. The Standard has not been calibrated as an antigen standard. NIBSC97/562
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. 人重组凝血因子IXa国际标准物质
通过国际合作研究确定了该标准的效力，发现与来自黑色素瘤细胞培养的组织纤溶酶原激活剂的第二个国际标准（86/670）（2）相比，该标准为10000 IU/安瓿（1）。该标准由世界卫生组织（WHO）生物标准化专家委员会于2000年10月制定。国际合作研究的结果表明，组织纤溶酶原激活剂的第三个国际标准（98/714）是黑色素瘤细胞衍生酶和重组酶的合适标准，并且可能适用于测定其他来源的组织纤溶酶原活化剂（1）。使用基于纤维蛋白的测定方法分配组织纤溶酶原激活剂第三国际标准（98/714）的10000 IU/安瓿的效力。当使用替代分析方法解释结果时，建议谨慎。本标准旨在用作酶测定中的活性标准。该标准品尚未作为抗原标准品进行校准。
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。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。