Frontiers in Immunology (Feb 2023)
An external quality assessment feasibility study; cross laboratory comparison of haemagglutination inhibition assay and microneutralization assay performance for seasonal influenza serology testing: A FLUCOP study
- Joanna Waldock,
- Carol D. Weiss,
- Wei Wang,
- Min Z. Levine,
- Stacie N. Jefferson,
- Sammy Ho,
- Katja Hoschler,
- Brandon Z. Londt,
- Elisa Masat,
- Louise Carolan,
- Stephany Sánchez-Ovando,
- Stephany Sánchez-Ovando,
- Annette Fox,
- Annette Fox,
- Shinji Watanabe,
- Miki Akimoto,
- Aya Sato,
- Noriko Kishida,
- Amelia Buys,
- Lorens Maake,
- Cardia Fourie,
- Catherine Caillet,
- Sandrine Raynaud,
- Richard J. Webby,
- Jennifer DeBeauchamp,
- Rebecca J. Cox,
- Sarah L. Lartey,
- Claudia M. Trombetta,
- Serena Marchi,
- Emanuele Montomoli,
- Iván Sanz-Muñoz,
- José María Eiros,
- Javier Sánchez-Martínez,
- Danny Duijsings,
- Othmar G. Engelhardt
Affiliations
- Joanna Waldock
- Vaccines, Science Research & Innovation, Medicines and Healthcare Products Regulatory, Potters Bar, United Kingdom
- Carol D. Weiss
- Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States
- Wei Wang
- Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States
- Min Z. Levine
- Influenza Division, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Atlanta, GA, United States
- Stacie N. Jefferson
- Influenza Division, Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, Atlanta, GA, United States
- Sammy Ho
- Respiratory Viruses Unit, UK Health Security Agency, Colindale, United Kingdom
- Katja Hoschler
- Respiratory Viruses Unit, UK Health Security Agency, Colindale, United Kingdom
- Brandon Z. Londt
- hVivo The Queen Mary Bioenterprises (QMB) Innovation, London, United Kingdom
- Elisa Masat
- hVivo The Queen Mary Bioenterprises (QMB) Innovation, London, United Kingdom
- Louise Carolan
- World Health Organisation (WHO) Collaborating Centre for Reference and Research on Influenza, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- Stephany Sánchez-Ovando
- World Health Organisation (WHO) Collaborating Centre for Reference and Research on Influenza, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- Stephany Sánchez-Ovando
- Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- Annette Fox
- World Health Organisation (WHO) Collaborating Centre for Reference and Research on Influenza, Royal Melbourne Hospital, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- Annette Fox
- Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia
- Shinji Watanabe
- Center for Influenza and Respiratory Virus Research, National Institute of Infectious Diseases: Musashi-Murayama, Tokyo, Japan
- Miki Akimoto
- Center for Influenza and Respiratory Virus Research, National Institute of Infectious Diseases: Musashi-Murayama, Tokyo, Japan
- Aya Sato
- Center for Influenza and Respiratory Virus Research, National Institute of Infectious Diseases: Musashi-Murayama, Tokyo, Japan
- Noriko Kishida
- Center for Influenza and Respiratory Virus Research, National Institute of Infectious Diseases: Musashi-Murayama, Tokyo, Japan
- Amelia Buys
- Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services, Johannesburg, South Africa
- Lorens Maake
- Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services, Johannesburg, South Africa
- Cardia Fourie
- Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases (NICD) of the National Health Laboratory Services, Johannesburg, South Africa
- Catherine Caillet
- 0Department of Research and Development, Sanofi, Lyon, France
- Sandrine Raynaud
- 0Department of Research and Development, Sanofi, Lyon, France
- Richard J. Webby
- 1Department of Infectious Diseases, St Jude Children’s Research Hospital, Memphis, TN, United States
- Jennifer DeBeauchamp
- 1Department of Infectious Diseases, St Jude Children’s Research Hospital, Memphis, TN, United States
- Rebecca J. Cox
- 2Influenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway
- Sarah L. Lartey
- 2Influenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway
- Claudia M. Trombetta
- 3Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy
- Serena Marchi
- 3Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy
- Emanuele Montomoli
- 3Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy
- Iván Sanz-Muñoz
- 4National Influenza Centre of Valladolid, Instituto de Estudios de Ciencias de la Salud de Castilla y León (ICSCYL), Edificio Rondilla, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- José María Eiros
- 4National Influenza Centre of Valladolid, Instituto de Estudios de Ciencias de la Salud de Castilla y León (ICSCYL), Edificio Rondilla, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- Javier Sánchez-Martínez
- 4National Influenza Centre of Valladolid, Instituto de Estudios de Ciencias de la Salud de Castilla y León (ICSCYL), Edificio Rondilla, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- Danny Duijsings
- 5Viroclinics, Clinical Virology Services, Rotterdam, Netherlands
- Othmar G. Engelhardt
- Vaccines, Science Research & Innovation, Medicines and Healthcare Products Regulatory, Potters Bar, United Kingdom
- DOI
- https://doi.org/10.3389/fimmu.2023.1129765
- Journal volume & issue
-
Vol. 14
Abstract
IntroductionExternal Quality Assessment (EQA) schemes are designed to provide a snapshot of laboratory proficiency, identifying issues and providing feedback to improve laboratory performance and inter-laboratory agreement in testing. Currently there are no international EQA schemes for seasonal influenza serology testing. Here we present a feasibility study for conducting an EQA scheme for influenza serology methods.MethodsWe invited participant laboratories from industry, contract research organizations (CROs), academia and public health institutions who regularly conduct hemagglutination inhibition (HAI) and microneutralization (MN) assays and have an interest in serology standardization. In total 16 laboratories returned data including 19 data sets for HAI assays and 9 data sets for MN assays.ResultsWithin run analysis demonstrated good laboratory performance for HAI, with intrinsically higher levels of intra-assay variation for MN assays. Between run analysis showed laboratory and strain specific issues, particularly with B strains for HAI, whilst MN testing was consistently good across labs and strains. Inter-laboratory variability was higher for MN assays than HAI, however both assays showed a significant reduction in inter-laboratory variation when a human sera pool is used as a standard for normalization.DiscussionThis study has received positive feedback from participants, highlighting the benefit such an EQA scheme would have on improving laboratory performance, reducing inter laboratory variation and raising awareness of both harmonized protocol use and the benefit of biological standards for seasonal influenza serology testing.
Keywords
- influenza viruses
- external quality assessment (EQA)
- haemagglutination inhibition (HAI)
- microneutralization (MN)
- serology
- standardization