D Goldblatt, A McKeen, P Burbidge, S McElhiney, L McLaughlin, A Johnson, M Rauh, P C Giardina
The pneumococcal ELISA reference standard serum, Lot 89SF, has been in use since 1990 and was replaced with a new reference standard serum, 007sp in 2013. This serum was generated under an FDA-approved clinical protocol, where 278 adult volunteers were immunized with the 23-valent unconjugated polysaccharide vaccine, Pneumovax II®, and a unit of blood was obtained twice within 120 days following immunization. Pooled serum was prepared from the plasma, filled at 6ml per vial and lyophilised. Five independent laboratories participated in bridging the serotype specific IgG assignments for 89SF to 007sp to establish equivalent reference values for 13 pneumococcal capsular serotypes (1,3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) using the WHO reference ELISA...
July 19, 2017: Clinical and Vaccine Immunology: CVI