2014-10-24-世界卫生组织-WHO_BS_2014.2239_International_collaborative_study_for_the_calibration_of_a_replacement_IS_for_the_WHO_1st_IS_for_Haemophilus_influenzae_type_b_polysaccharide_43页_987kb

This report summarizes an international collaborative study aimed at calibrating a replacement International Standard (IS) for Haemophilus influenzae type b (Hib) capsular polysaccharide PRP. Two candidate preparations were evaluated by 13 laboratories from 9 countries. The study focused on determining the PRP content and suitability for use in vaccine quality control using the ribose assay.

Key findings indicate that Candidate 2 (NIBSC code 12/306) has a high PRP content of 4.904 ± 0.185 mg/ampoule and better stability compared to Candidate 1. The study recommended establishing Candidate 2 as the second WHO International Standard for PRP, with potential for use in various quantitative assays like ribose, phosphorus, and HPAEC-PAD methods. This standard provides continuity and supports global vaccine safety and efficacy.