Evidence map›Paper›PMID 34425105›Full record

ArticleClinica chimica acta; international journal of clinical chemistry2021

Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects.

Davide Ferrari, Nicola Clementi, Sestina Maria Spanò, Sami Albitar-Nehme, Stefania Ranno, Alessandra Colombini, Elena Criscuolo, Chiara Di Resta, Rossella Tomaiuolo, Marco Viganó and 6 more

Open access · greenAbstract read
In one paragraph

Article in Clinica chimica acta; international journal of clinical chemistry, 2021. 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
2.0field-weighted citation impact, top 11% 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, 31 citations in OpenAlex.

  1. Robust Regression Techniques for Multiple Method Comparison and Transformation.Biometrical journal. Biometrische Zeitschrift · 2024
    Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Longitudinal dynamics of SARS-CoV-2 anti-receptor binding domain IgG antibodies in a wide population of health care workers after BNT162b2 vaccination.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. Observational
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. 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

16 authors at 6 institutions in 1 country.

Davide FerrariSCVSA Department, University of Parma, 43121 Parma, Italy. Electronic address: davide.ferrari@unipr.it.
Nicola ClementiLaboratory of Microbiology and Virology, Vita-Salute San Raffaele University, 20158 Milan, Italy; IRCCS Ospedale San Raffaele, 20158 Milan, Italy.
Sestina Maria SpanòIRCCS Orthopedic Institute Galeazzi, Laboratory of Clinical Chemistry and Microbiology, 20161 Milan, Italy.
Sami Albitar-NehmeMicrobiology and Immunology Diagnostics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Stefania RannoMicrobiology and Immunology Diagnostics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Alessandra ColombiniIRCCS Orthopedic Institute Galeazzi, Laboratorio di Biotecnologie Applicate all'Ortopedia, Milan, Italy.
Elena CriscuoloLaboratory of Microbiology and Virology, Vita-Salute San Raffaele University, 20158 Milan, Italy.
Chiara Di RestaIRCCS Ospedale San Raffaele, 20158 Milan, Italy.
Rossella TomaiuoloLaboratory of Microbiology and Virology, Vita-Salute San Raffaele University, 20158 Milan, Italy; IRCCS Ospedale San Raffaele, 20158 Milan, Italy.
Marco ViganóIRCCS Orthopedic Institute Galeazzi, Laboratorio di Biotecnologie Applicate all'Ortopedia, Milan, Italy.
Nicasio ManciniLaboratory of Microbiology and Virology, Vita-Salute San Raffaele University, 20158 Milan, Italy; IRCCS Ospedale San Raffaele, 20158 Milan, Italy.
Elena De VecchiIRCCS Orthopedic Institute Galeazzi, Laboratory of Clinical Chemistry and Microbiology, 20161 Milan, Italy.
Massimo LocatelliIRCCS Ospedale San Raffaele, 20158 Milan, Italy.
Alessandra MangiaLiver Unit, Department of Medical Sciences, IRCCS Fondazione, "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy.
Carlo Federico PernoMicrobiology and Immunology Diagnostics, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
Giuseppe BanfiIRCCS Orthopedic Institute Galeazzi, Laboratory of Clinical Chemistry and Microbiology, 20161 Milan, Italy; University Vita-Salute San Raffaele, 20158 Milan, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITIRCCS Ospedale San Raffaele · ITVita-Salute San Raffaele University · ITIstituto Ortopedico Galeazzi · ITBambino Gesù Children's Hospital · ITUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsVaccines, to limit SARS-CoV-2 infection, were produced and reliable assays are needed for their evaluation. The WHO produced an International-Standard (WHO-IS) to facilitate the standardization/comparison of serological methods. The WHO-IS, produced in limited amount, was never tested for reproducibility. This study aims at developing a reproducible and accessible working standard (WS) to complement the WHO-IS. MATERIALS AND

methodsSera from vaccinated individuals were used to produce the WSs. The WHO-IS, the WSs and single serum samples (n = 48) were tested on 6 quantitative serological devices. Neutralization assays were performed for the 48 samples and compared with their antibody titers.

resultsThe WS carry an antibody titer 20-fold higher than the WHO-IS. It was reproducible, showed both good linearity and insignificant intra- and inter-laboratory variability. However, the WSs behave differently from the WHO-IS. Analysis of the 48 samples showed that single correlation factors are not sufficient to harmonize results from different assays. Yet, all the devices predict neutralization activity based on the antibody titer.

conclusionsA reproducible and highly concentrated WS, specific for IgG against SARS-CoV-2 Spike-glycoprotein was produced. Such characteristics make it particularly suited for the harmonization of commercially available assays and the consequent evaluation of post-vaccinated individuals.

Indexed as

COVID-19SARS-CoV-2Antibodies, NeutralizingAntibodies, ViralHumansNeutralization TestsReproducibility of ResultsAntibodies, NeutralizingAntibodies, ViralComirnaty vaccineCOVID-19NeutralizationSARS-CoV-2Serological standardWHO

Identifiers

PMID34425105
PMCPMC8378065
OpenAlexW3193402085

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.