Author:
Waldock Joanna,Weiss Carol D.,Wang Wei,Levine Min Z.,Jefferson Stacie N.,Ho Sammy,Hoschler Katja,Londt Brandon Z.,Masat Elisa,Carolan Louise,Sánchez-Ovando Stephany,Fox Annette,Watanabe Shinji,Akimoto Miki,Sato Aya,Kishida Noriko,Buys Amelia,Maake Lorens,Fourie Cardia,Caillet Catherine,Raynaud Sandrine,Webby Richard J.,DeBeauchamp Jennifer,Cox Rebecca J.,Lartey Sarah L.,Trombetta Claudia M.,Marchi Serena,Montomoli Emanuele,Sanz-Muñoz Iván,Eiros José María,Sánchez-Martínez Javier,Duijsings Danny,Engelhardt Othmar G.
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.
Funder
Innovative Medicines Initiative
Subject
Immunology,Immunology and Allergy