Preparation of human pneumococcal reference serum BW09 and assignment of IgG antibody concen-trations for 24 serotypes / 中华微生物学和免疫学杂志

ABSTRACT

Objective To prepare human pneumococcal reference serum and assign IgG antibody concentrations for its 24 serotypes. Methods Fifty healthy male and non-pregnant female volunteers were vaccinated once with 23-valent pneumococcal polysaccharide vaccine. Plasma samples were collected follow-ing immunization and used to prepare reference serum BW09. IgG antibody concentrations of BW09 against the capsular polysaccharides of 24 serotypes (1, 2, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) were assigned by WHO recommended standardized Pn PS ELISA using 09CS (supplied by Lanzhou Institute of Biological Products Co. , Ltd) as a reference se-rum. Finally, 09CS, two quality control sera and eight serum samples had concentrations reassigned for 24 pneumococcal serotypes using BW09 as the reference, and the results were compared with those using 09CS as the reference serum. Results Glycerol-contained human pneumococcal reference serum BW09 was pre-pared and the IgG antibody concentrations for its 24 serotypes were assigned. 09CS had concentrations reas-signed for 24 pneumococcal serotypes using BW09 as the reference, and the newly assigned concentrations were similar to the original values (with percentage error less than 10％ in all serotypes). IgG antibodies against capsular polysaccharides of 24 serotypes of two quality control sera and eight serum samples were as-signed by BW09 and 09CS, and the results showed a linear correlation. Conclusions The human pneumo-coccal reference serum BW09 was successfully prepared and IgG antibody concentrations for its 24 serotypes were accurately assigned.