Poole S, Mussett M V
National Institute for Biological Standards and Control, Hertfordshire, UK.
J Biol Stand. 1989 Apr;17(2):161-71. doi: 10.1016/0092-1157(89)90006-1.
An ampouled preparation of bacterial endotoxin, coded 84/650, was evaluated in 35 laboratories in 12 countries for its suitability to serve as the International Standard for Endotoxin. The ampouled preparation was calibrated in terms of the USA National Standard, EC5, in Limulus Amoebocyte Lysate gelation, turbidimetric and chromogenic tests and in rabbit pyrogen tests. On the basis of the results reported here, with the agreement of the participants in the study, and with the authorization of the Expert Committee on Biological Standardization of the World Health Organization, the preparation coded 84/650 was established in 1986 as the International Standard for Endotoxin for Limulus Gelation Tests with an assigned unitage of 14,000 IU of endotoxin per ampoule.
一种编码为84/650的细菌内毒素安瓿制剂,在12个国家的35个实验室中进行了评估,以确定其是否适合作为内毒素国际标准品。该安瓿制剂依据美国国家标准EC5,通过鲎试剂凝胶法、比浊法和显色法检测以及家兔热原试验进行了校准。根据此处报告的结果,经本研究参与者同意,并经世界卫生组织生物标准化专家委员会批准,编码为84/650的制剂于1986年被确立为用于鲎试剂凝胶法检测的内毒素国际标准品,每安瓿的内毒素标定单位为14,000国际单位。