Evidence map›Paper›PMID 34461153›Full record

ArticleJournal of virological methods2021

Performance evaluation of the Roche Elecsys Anti-SARS-CoV-2 S immunoassay.

Elena Riester, Peter Findeisen, J Kolja Hegel, Michael Kabesch, Andreas Ambrosch, Christopher M Rank, Florina Pessl, Tina Laengin, Christoph Niederhauser

Open access · hybridAbstract read
In one paragraph

Article in Journal of virological methods, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed
7.0field-weighted citation impact, top 2% 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

89 citing papers in PubMed, 122 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Anti-GPV activity ofFrontiers in microbiology · 2026
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

29 more citing papers are in PubMed but not listed here.

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

9 authors at 5 institutions in 2 countries.

Elena RiesterLabor Augsburg MVZ GmbH, Augsburg, Germany.
Peter FindeisenMVZ Labor Limbach, Heidelberg, Germany.
J Kolja HegelLabor Berlin, Charité Vivantes Services GmbH, Berlin, Germany.
Michael KabeschUniversity Children's Hospital Regensburg (KUNO) at the Hospital St. Hedwig of the Order of St. John and the University Hospital, University of Regensburg, Germany.
Andreas AmbroschInstitute for Laboratory Medicine, Microbiology and Hygiene, Barmherzige Brüder Hospital, Regensburg, Germany.
Christopher M RankRoche Diagnostics GmbH, Penzberg, Germany.
Florina PesslRoche Diagnostics GmbH, Penzberg, Germany.
Tina LaenginRoche Diagnostics GmbH, Penzberg, Germany.
Christoph NiederhauserInterregionale Blood Transfusion Swiss Red Cross, Bern, Switzerland; Institute for Infectious Diseases (IFIK), University of Bern, Bern, Switzerland. Electronic address: Christoph.Niederhauser@itransfusion.ch.
Roche Pharma AG (Germany) · DEKrankenhaus Barmherzige Brüder · DEUniversity of Bern · CHUniversity of Regensburg · DEVivantes Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Elecsys® Anti-SARS-CoV-2 S immunoassay (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) has been developed for the detection of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. We evaluated the assay performance using samples from seven sites in Germany, Austria, and Switzerland. For specificity and sensitivity analyses, 7880 presumed negative pre-pandemic samples and 827 SARS-CoV-2 PCR-confirmed single or sequential samples from 272 different patients were tested, respectively. The overall specificity and sensitivity (≥14 days post-PCR) for the Elecsys Anti-SARS-CoV-2 S immunoassay were 99.95% (95% confidence interval [CI]: 99.87-99.99; 7876/7880) and 97.92% (95% CI: 95.21-99.32; 235/240), respectively. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher specificity compared with the LIAISON® SARS-CoV-2 S1/S2 IgG (99.95% [2032/2033] vs 98.82% [2009/2033]), ADVIA Centaur® SARS-CoV-2 Total (100% [928/928] vs 86.96% [807/928]), ARCHITECT SARS-CoV-2 IgG (99.97% [2931/2932] vs 99.69% [2923/2932]), iFlash-SARS-CoV-2 IgM (100.00% [928/928] vs 99.57% [924/928]), and EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% [903/903] vs 97.45% [880/903]) and IgA (100.00% [895/895] vs 95.75% [857/895]) assays. The Elecsys Anti-SARS-CoV-2 S immunoassay had significantly higher sensitivity (≥14 days post-PCR) compared with the ARCHITECT SARS-CoV-2 IgG (98.70% [76/77] vs 87.01% [67/77]), iFlash-SARS-CoV-2 IgG (100.00% [76/76] vs 93.42% [71/76]) and IgM (100.00% [76/76] vs 35.53% [27/76]), and EUROIMMUN Anti-SARS-CoV-2 IgG (98.26% [113/115] vs 93.91% [108/115]) assays. Therefore, the Elecsys Anti-SARS-CoV-2 S assay demonstrated a reliable performance across various sample populations for the detection of anti-S antibodies.

Indexed as

COVID-19SARS-CoV-2Antibodies, ViralHumansImmunoassaySensitivity and SpecificityAntibodies, ViralAntibodiesImmunoassayNucleocapsid proteinSARS-CoV-2Spike protein

Identifiers

PMID34461153
PMCPMC8393518
OpenAlexW3198207072

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.