Collaborative calibration for the 2nd generation WHO international reference standard of pertussis toxin
WEI Chen
CHAO Zhe
WU Yan
WANG Li-chan
LUO Peng
MA Xiao
Abstract：Objective: To establish the 2 ndgeneration WHO international reference standard of pertussis toxin. Methods: The candidate reagent provided by the NIBSC and NIFDC were assayed against the 1 stgeneration WHO pertussis toxin standard. The histamine sensitisation test, CHO cell clustering test and three biochemical test methods were used to calculate the IU and investigate the sability. Results: Two tests of histamine sensitization, CHO cell clustering test and a biochemical test were performed in NIFDC. Conclusion: After statistical analysis of the results from 14 laboratories in 12 countries, NIBSC assigned the histamine sensitization activity of the 2 nd generaion WHO pertussis toxin international reference standard to 1 813 IU·ampoule-1, CHO cell cluster activity to680 IU/ampoule. The storage and transport stabilities meet the requirements.
Keywords：international reference standardspertussis toxinhistamine sensitizationCHO cell cluster
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1855-1860 )