長崎大学：肺炎球菌ワクチンの効果に対する一括評価方法の開発

Thank you very much for your kind support for this crowdfunding project.

We would like to inform you that this assay is based on microspheres, a relatively new technology. There are few other research groups in the world who have used similar technology to assess the antibodies against pneumococcal vaccines. However, there is a lack of a standardized protocol, and there is no international quality assessment system.

World Health Organization (WHO) recommends enzyme immunoassays (EIA) as standard methods, but it also recognizes that EIA is laborious, time-consuming, and costly. WHO has mentioned that a microsphere-based method is efficient as well as sensitive and specific, and it can generate reproducible data. As it is a new system, it needs standardization and validation so that data can be compared among laboratories around the world and interpreted accurately.

To address the issues of protocol standardization and international quality assessment, the EU Pneumo Multiplex Assay Consortium was started in 2013 in the European Union. The main objectives of this non-profit consortium are to share knowledge, analyze, and harmonize the multiplex assay protocols, and it also provides a system for international quality assessment.

As we would like to develop and validate our assay with international standards, we have started communicating with the EU Pneumo Multiplex Assay Consortium for their guidance and quality assessment.

References:

1. Meek B, Ekström N, Kantsø B, Almond R, Findlow J, Gritzfeld JF, Sværke Jørgensen C, Ljungberg K, Atterfelt F, Batstra MR, Andeweg K, de Jong BAW, Prince HE, Lapé-Nixon M, Gageldonk PGM, Tcherniaeva I, Aaberge I, Herstad TK, Melin M, Rijkers GT, Berbers GA. Multilaboratory Comparison of Pneumococcal Multiplex Immunoassays Used in Immunosurveillance of Streptococcus pneumoniae across Europe. mSphere. 2019

2. Käyhty H, Nurkka A, Soininen A, Väkeväinen M. The immunological basis for immunization series. Module 12: pneumococcal vaccines. World Health Organization. 2009.