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

Front Immunol. 2023 Feb 28:14:1129765. doi: 10.3389/fimmu.2023.1129765. eCollection 2023.

Abstract

Introduction: External 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.

Methods: We 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.

Results: Within 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.

Discussion: This 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: external quality assessment (EQA); haemagglutination inhibition (HAI); influenza viruses; microneutralization (MN); serology; standardization.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Feasibility Studies
  • Hemagglutination
  • Humans
  • Influenza, Human*
  • Laboratories
  • Seasons

Grants and funding

This study was funded by the Innovative Medicines Initial Joint Undertaking (IMI JU) under grant agreement 115672, with financial contribution from the European Union Seventh Framework Programme (FP/2007-2013) and EFPIA companies’ in-kind contribution. The Melbourne WHO Collaborating Centre for Reference and Research on Influenza is supported by the Australian Government Department of Health.