Evidence map›Paper›PMID 37958688›Full record

ArticleInternational journal of molecular sciences2023

Monoclonal Antibodies as SARS-CoV-2 Serology Standards: Experimental Validation and Broader Implications for Correlates of Protection.

Lili Wang, Paul N Patrone, Anthony J Kearsley, Jerilyn R Izac, Adolfas K Gaigalas, John C Prostko, Hyung Joon Kwon, Weichun Tang, Martina Kosikova, Hang Xie and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
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

19 authors.

Lili WangBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.ORCID 0000-0003-2456-898X
Paul N PatroneApplied and Computational Mathematics Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.
Anthony J KearsleyApplied and Computational Mathematics Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.
Jerilyn R IzacBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.ORCID 0000-0003-1762-4680
Adolfas K GaigalasBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.
John C ProstkoAbbott Laboratories, Abbott Park, IL 60064, USA.
Hyung Joon KwonLaboratory of Pediatric and Respiratory Viral Diseases, Office of Vaccines Research and Review, Center for Biologics Evaluation, Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Weichun TangLaboratory of Pediatric and Respiratory Viral Diseases, Office of Vaccines Research and Review, Center for Biologics Evaluation, Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Martina KosikovaLaboratory of Pediatric and Respiratory Viral Diseases, Office of Vaccines Research and Review, Center for Biologics Evaluation, Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
Hang XieLaboratory of Pediatric and Respiratory Viral Diseases, Office of Vaccines Research and Review, Center for Biologics Evaluation, Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.ORCID 0000-0001-8318-5554
Linhua TianBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.ORCID 0000-0001-8848-1790
Elzafir B ElsheikhBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.
Edward J KweeBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.ORCID 0000-0001-5460-3913
Troy KempVaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research (FNLCR), Frederick, MD 21702, USA.
Simon JochumRoche Diagnostics GmbH, 82377 Penzberg, Germany.
Natalie ThornburgCenters for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.ORCID 0000-0003-3523-3616
L Clifford McDonaldCenters for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.ORCID 0000-0003-3044-5572
Adi V GundlapalliCenters for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA.
Sheng Lin-GibsonBiosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

COVID-19 has highlighted challenges in the measurement quality and comparability of serological binding and neutralization assays. Due to many different assay formats and reagents, these measurements are known to be highly variable with large uncertainties. The development of the WHO international standard (WHO IS) and other pool standards have facilitated assay comparability through normalization to a common material but does not provide assay harmonization nor uncertainty quantification. In this paper, we present the results from an interlaboratory study that led to the development of (1) a novel hierarchy of data analyses based on the thermodynamics of antibody binding and (2) a modeling framework that quantifies the probability of neutralization potential for a given binding measurement. Importantly, we introduced a precise, mathematical definition of harmonization that separates the sources of quantitative uncertainties, some of which can be corrected to enable, for the first time, assay comparability. Both the theory and experimental data confirmed that mAbs and WHO IS performed identically as a primary standard for establishing traceability and bridging across different assay platforms. The metrological anchoring of complex serological binding and neuralization assays and fast turn-around production of an mAb reference control can enable the unprecedented comparability and traceability of serological binding assay results for new variants of SARS-CoV-2 and immune responses to other viruses.

Indexed as

COVID-19SARS-CoV-2Antibodies, MonoclonalAntibodies, NeutralizingAntibodies, ViralBiological AssayData AnalysisHumansAntibodies, MonoclonalAntibodies, NeutralizingAntibodies, Viralharmonizationmonoclonal antibodyneutralization assaynormalizationresult comparability and traceabilitySARS-CoV-2serological binding assayspike proteinuncertainty quantificationWHO international standard (WHO IS)

Identifiers

PMID37958688
PMCPMC10650176

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.