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

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.

Haemagglutination inhibition and virus microneutralisation serology assays: use of harmonised protocols and biological standards in seasonal influenza serology testing and their impact on inter-laboratory variation and assay correlation: A FLUCOP collaborative study

“…lineage viruses. We see a clear difference between A and B viruses: titres for in-house testing for A viruses were almost always higher than FLUCOP testing, however for the B viruses, in-house testing gave much lower titresthis is likely due to the use of ether split antigen for FLUCOP testing (but mixed use of native and ether split antigen for in-house testing) as demonstrated in previous studies (20,21).…”

Ensure the accuracy and consistency of biochemical analyzer test results: Chemometrics for instrument and inter-instrument item comparison in Chinese hospital laboratory

“…Under such a large test load, our laboratory must regularly conduct a systematic evaluation of equipment and period verification to ensure the accuracy of experimental data. At present, there are many pieces of research on period verification, such as internal quality control and external quality assessment [ [5] , [6] , [7] , [8] ]. Almost all research on the systematic evaluation of instruments focuses on methodological performance verification and validation experiments of clinical items [ [9] , [10] , [11] , [12] , [13] ], and almost no one pays attention to the analytical performance evaluation of the instrument itself.…”