Evidence map›Paper›PMID 36532081›Full record

ArticleFrontiers in immunology2022

Design and performance characteristics of the Elecsys anti-SARS-CoV-2 S assay.

Karin Taffertshofer, Mirko Walter, Peter Mackeben, Julia Kraemer, Sergej Potapov, Simon Jochum

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 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.3field-weighted citation impact, top 18% 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

16 citing papers in PubMed, 13 citations in OpenAlex.

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  14. A Case of Autoimmune Small Fiber Neuropathy as Possible Post COVID Sequelae.International journal of environmental research and public health · 2023
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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

6 authors at 1 institution in 1 country.

Karin TaffertshoferResearch and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Mirko WalterResearch and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Peter MackebenResearch and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Julia KraemerResearch and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Sergej PotapovBiostatistics & Data Science, Roche Diagnostics GmbH, Penzberg, Germany.
Simon JochumResearch and Development Immunoassays, Roche Diagnostics GmbH, Penzberg, Germany.
Roche Pharma AG (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Automated, high throughput assays are required to quantify the immune response after infection with or vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This study on the Roche Elecsys Methods: The ACOV2S assay quantifies antibodies to the receptor-binding domain of the SARS-CoV-2 spike protein. The assigned units and the underlying standardization were compared to the international reference standard in BAU/mL. Assay specificity was assessed in samples (n=5981) collected prior to the COVID-19 pandemic and in samples from patients with non-COVID-19 respiratory infections (n=697) or other infectious diseases (n=771). Sensitivity was measured in 1313 samples from patients with mild COVID-19 and 297 samples from patients hospitalized with COVID-19. Comparison of results was performed to a comparator semi-quantitative anti-S1 assay of indirect detection format as well as a commercially available and an in-house version of a surrogate neutralization assay (ACE2-RBD). Results: The originally assigned units for the ACOV2S assay were shown to be congruent to the units of the First International WHO Standard for anti-SARS-CoV-2 immunoglobulins. Overall specificity was 99.98% with no geographical differences noted and no loss of specificity in samples containing potentially cross-reacting antibodies. High sensitivity was observed, with 98.8% of samples reported to be reactive >14 days after infection and sustained detection of antibodies over time. For all samples, ACOV2S titers and neutralization capacities developed with comparable dynamics. Robust standardization and assay setup enable excellent reproducibility of results, independent of lot or analyzer used. Conclusion: The results from this study confirmed that ACOV2S is a highly sensitive and specific assay and correlates well with surrogate neutralization assays. The units established for ACOV2S are also interchangeable with the units of the First International WHO Standard for anti-SARS-CoV-2 immunoglobulins. Worldwide availability of the assay and analyzers render ACOV2S a highly practical tool for population-wide assessment and monitoring of the humoral response to SARS-CoV-2 infection or vaccination.

Indexed as

COVID-19SARS-CoV-2Antibodies, ViralHumansPandemicsReproducibility of ResultsSensitivity and SpecificitySpike Glycoprotein, CoronavirusAntibodies, ViralSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2COVID-19neutralizationquantitative serologySARS-CoV-2sensitivityspecificity

Identifiers

PMID36532081
PMCPMC9756759
OpenAlexW4311191400

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.