Gaines Das R, Xing D, Rigsby P, Newland P, Corbel M
Informatics Laboratory, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, UK.
Biologicals. 2001 Jun;29(2):137-48. doi: 10.1006/biol.2001.0288.
A freeze dried preparation of mouse serum in vials coded 97/642 containing antibodies to five pertussis antigens [pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae type 2 and 3 (Fim 2 and 3)] has been assessed for its suitability as an international reference reagent in an international collaborative study by thirteen laboratories in nine countries. This serum has been compared with U.S. Standard Pertussis Antiserum (mouse) Lot No. 1 (US Lot 1), which has been in use since 1995, for antibodies for each antigen. Calibration of the proposed International Reference Reagent of Pertussis Antiserum (pIRR) in terms of US Lot 1 gives results which are broadly consistent between laboratories for antibodies to each antigen, although the between-laboratory differences are larger than those seen for comparison of identical sera. Calibration of two positive control sera in terms of the pIRR gave similar between laboratory variability of estimates to that obtained when the same sera were calibrated in terms of US Lot 1. Overall continuity of estimates is maintained if units are assigned to the pIRR based on its calibration in terms of US Lot 1 in this study. Data presently available indicate that the pIRR is sufficiently stable to serve as a reference reagent. It was therefore recommended, with the agreement of all participants, that the preparation in vials coded 97/642 be established as the First International Reference Reagent for Pertussis Antiserum, mouse, with assigned unitages 16 units of anti-PT per vial, 143 units of anti-FHA per vial and 30 units of anti-PRN per vial based on its calibration in terms of US Lot 1. These unitages are also consistent with calibration of 97/642 in terms of the Japanese preparations JNIH-11 for anti-FHA and of JNIH-12 for anti-PT. Purified antigens for Fim 2 and Fim 3 are not readily available and an arbitrary value of 32 units per vial is suggested for anti-Fim 2 and 3 mixture. These recommendations were agreed by the Expert Committee on Biological Standardization of the World Health Organization.
编码为97/642的小瓶冻干小鼠血清制剂含有针对五种百日咳抗原[百日咳毒素（PT）、丝状血凝素（FHA）、百日咳杆菌黏附素（PRN）、2型和3型菌毛（Fim 2和Fim 3）]的抗体，在一项由九个国家的13个实验室参与的国际协作研究中，对其作为国际参考试剂的适用性进行了评估。将该血清与自1995年起使用的美国标准百日咳抗血清（小鼠）批号1（美国批号1）针对每种抗原的抗体进行了比较。根据美国批号1对拟议的国际百日咳抗血清参考试剂（pIRR）进行校准，各实验室针对每种抗原抗体得出的结果大致一致，不过实验室间差异比相同血清比较时所见的差异更大。根据pIRR对两种阳性对照血清进行校准，得出的实验室间估计变异性与根据美国批号1对相同血清进行校准时获得的变异性相似。如果在本研究中根据pIRR相对于美国批号1的校准为其指定单位，则估计值的总体连续性得以保持。目前可得的数据表明，pIRR足够稳定，可作为参考试剂。因此，在所有参与者达成一致意见后，建议将编码为97/642的小瓶制剂确立为第一国际参考百日咳抗血清（小鼠），根据其相对于美国批号1的校准，每小瓶指定单位为：抗PT 16单位/小瓶、抗FHA 143单位/小瓶和抗PRN 30单位/小瓶。这些单位也与97/642相对于日本制剂JNIH - 11（抗FHA）和JNIH - 12（抗PT）的校准一致。Fim 2和Fim 3的纯化抗原不易获得，建议抗Fim 2和3混合物每小瓶的任意值为32单位。这些建议得到了世界卫生组织生物标准化专家委员会的认可。
