Evidence map›Paper›PMID 35784305›Full record

ArticleFrontiers in immunology2022

Validation of a Harmonized Enzyme-Linked-Lectin-Assay (ELLA-NI) Based Neuraminidase Inhibition Assay Standard Operating Procedure (SOP) for Quantification of N1 Influenza Antibodies and the Use of a Calibrator to Improve the Reproducibility of the ELLA-NI With Reverse Genetics Viral and Recombinant Neuraminidase Antigens: A FLUCOP Collaborative Study.

Marie-Clotilde Bernard, Joanna Waldock, Sylvie Commandeur, Lea Strauß, Claudia Maria Trombetta, Serena Marchi, Fan Zhou, Serge van de Witte, Peter van Amsterdam, Sammy Ho and 11 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 18 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 9 institutions in 8 countries.

Marie-Clotilde BernardDepartment of Research and Development, Sanofi Pasteur, Marcy L'Etoile, France.
Joanna WaldockInfluenza Resource Centre, National Institute for Biological Standards and Control, Potters Bar, United Kingdom.
Sylvie CommandeurDepartment of Research and Development, Sanofi Pasteur, Marcy L'Etoile, France.
Lea StraußSection viral vaccines, Virology Division, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Claudia Maria TrombettaDepartment of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
Serena MarchiDepartment of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
Fan ZhouInfluenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway.
Serge van de WitteAbbott Healthcare Products B.V., Weesp, Netherlands.
Peter van AmsterdamAbbott Healthcare Products B.V., Weesp, Netherlands.
Sammy HoUK Health Security Agency, Colindale, United Kingdom.
Katja HoschlerUK Health Security Agency, Colindale, United Kingdom.
Vladimir LugovtsevLaboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
Jerry P WeirLaboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.
Emanuele MontomoliDepartment of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
Rebecca J CoxInfluenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway.
Othmar G EngelhardtInfluenza Resource Centre, National Institute for Biological Standards and Control, Potters Bar, United Kingdom.
Damien FrielGlaxoSmithKline (GSK), Wavre, Belgium.
Ralf WagnerSection viral vaccines, Virology Division, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
Thierry OllingerGlaxoSmithKline (GSK), Wavre, Belgium.
Sophie GermainGlaxoSmithKline (GSK), Wavre, Belgium.
Hanna Sediri-SchönSection viral vaccines, Virology Division, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
GlaxoSmithKline (Belgium) · BEPaul Ehrlich Institut · DEUniversity of Siena · ITAbbott (Netherlands) · NLCenter for Biologics Evaluation and Research · USNational Institute for Biological Standards and Control · GBSanofi (France) · FRUK Health Security AgencyUniversity of Bergen · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Current vaccination strategies against influenza focus on generating an antibody response against the viral haemagglutination surface protein, however there is increasing interest in neuraminidase (NA) as a target for vaccine development. A critical tool for development of vaccines that target NA or include an NA component is available validated serology assays for quantifying anti-NA antibodies. Additionally serology assays have a critical role in defining correlates of protection in vaccine development and licensure. Standardisation of these assays is important for consistent and accurate results. In this study we first validated a harmonized enzyme-linked lectin assay (ELLA)- Neuraminidase Inhibition (NI) SOP for N1 influenza antigen and demonstrated the assay was precise, linear, specific and robust within classical acceptance criteria for neutralization assays for vaccine testing. Secondly we tested this SOP with NA from influenza B viruses and showed the assay performed consistently with both influenza A and B antigens. Third, we demonstrated that recombinant NA (rNA) could be used as a source of antigen in ELLA-NI. In addition to validating a harmonized SOP we finally demonstrated a clear improvement in inter-laboratory agreement across several studies by using a calibrator. Importantly we showed that the use of a calibrator significantly improved agreement when using different sources of antigen in ELLA-NI, namely reverse genetics viruses and recombinant NA. We provide a freely available and detailed harmonized SOP for ELLA-NI. Our results add to the growing body of evidence in support of developing biological standards for influenza serology.

Indexed as

Influenza, HumanInfluenza VaccinesAntibodies, ViralHumansLectinsNeuraminidaseReproducibility of ResultsReverse GeneticsAntibodies, ViralInfluenza VaccinesLectinsNeuraminidaseenzyme-linked lectin assay (ELLA)influenzaneuraminidase inhibition (NI) assayserologystandardization

Identifiers

PMID35784305
PMCPMC9248865
OpenAlexW4283010559

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.