WHO/BS/2022.2438: Report on the WHO collaborative study to investigate the utility of next generation sequencing (NGS) as a molecular test of virus stocks used in the manufacture of Type 1 and 2 Poliovirus vaccine (Oral)

Overview

This report summarizes the results for this second phase of the collaborative study for type 1 and 2 OPV. Eight study samples for type 1 and seven study samples for type 2 were analysed by two laboratories using their in-house NGS method and measurements compared to those from MAPREC. Intra-lab, between-laboratory, and within-assay variability of NGS estimates for 480A + 525C and 481G content for type 1 and 2 vaccines, respectively, across samples and laboratories were very low leading to excellent agreement between the two laboratories. Based on the long experience with MAPREC and results from this collaborative study, a test format and criteria for test validity and pass/fail decisions are discussed.