Evidence map›Paper›PMID 28729851›Full record

ArticleFrontiers in neurology2017

Development and Validation of an Enzyme-Linked Immunosorbent Assay for the Detection of Binding Anti-Drug Antibodies against Interferon Beta.

Kathleen Ingenhoven, Daniel Kramer, Poul Erik Jensen, Christina Hermanrud, Malin Ryner, Florian Deisenhammer, Marc Pallardy, Til Menge, Hans-Peter Hartung, Bernd C Kieseier and 4 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 35% 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

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
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

14 authors at 8 institutions in 7 countries.

Kathleen IngenhovenMedical Faculty, Department of Neurology, Heinrich-Heine-University, Duesseldorf, Germany.
Daniel KramerSanofi-Aventis, Deutschland GmbH, Frankfurt am Main, Germany.
Poul Erik JensenNeuroimmunology Laboratory, DMSC, Department of Neurology, Rigshospitalet, Copenhagen, Denmark.
Christina HermanrudDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Malin RynerDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Florian DeisenhammerDepartment of Neurology, Innsbruck Medical University, Innsbruck, Austria.
Marc PallardyINSERM 996, University Paris-Sud, Paris, France.
Til MengeMedical Faculty, Department of Neurology, Heinrich-Heine-University, Duesseldorf, Germany.
Hans-Peter HartungMedical Faculty, Department of Neurology, Heinrich-Heine-University, Duesseldorf, Germany.
Bernd C KieseierMedical Faculty, Department of Neurology, Heinrich-Heine-University, Duesseldorf, Germany.
Elisa BertottiMerck NBE Bioanalytics, Torino, Italy.
Paul CreekeCentre for Neuroscience and Trauma, Blizard Institute, Queen Mary, University of London, London, United Kingdom.
Anna Fogdell-HahnDepartment of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
Clemens WarnkeMedical Faculty, Department of Neurology, Heinrich-Heine-University, Duesseldorf, Germany.
Heinrich Heine University Düsseldorf · DEKarolinska Institutet · SEInnsbruck Medical University · ATInserm · FRMerck Serono (Italy) · ITQueen Mary University of London · GBRigshospitalet · DKSanofi (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo develop and validate a method for the detection of binding anti-drug antibodies (ADAs) against interferon beta (IFN-β) in human serum as part of a European initiative (ABIRISK) aimed at the prediction and analysis of clinical relevance of anti-biopharmaceutical immunization to minimize the risk.

methodA two-tiered bridging enzyme-linked immunosorbent assay (ELISA) format was selected and validated according to current recommendations.

resultsThe assay is precise, and the sensitivity of the assay was confirmed to be 26 ng/mL using commercially available polyclonal rabbit antihuman IFN-β in human sera as the positive control.

conclusionAn ultrasensitive ELISA for IFN-β-binding ADA testing has been validated. This will form the basis to assess anti-biopharmaceutical immunization toward IFN-β with regards to its clinical relevance and may allow for the development of predictive tools, key aims within the ABIRISK consortium.

Indexed as

anti-drug antibodiesbiotherapyenzyme-linked immunosorbent assayinterferon betamultiple sclerosis

Identifiers

PMID28729851
PMCPMC5498465
OpenAlexW2726778992

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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.