Evidence map›Paper›PMID 33397956›Full record

ArticleNature communications2021

Standardization of ELISA protocols for serosurveys of the SARS-CoV-2 pandemic using clinical and at-home blood sampling.

Carleen Klumpp-Thomas, Heather Kalish, Matthew Drew, Sally Hunsberger, Kelly Snead, Michael P Fay, Jennifer Mehalko, Anandakumar Shunmugavel, Vanessa Wall, Peter Frank and 11 more

Registry-linked trialAbstract read
In one paragraph

Article in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06939556 (Development of a High-throughput Serological Testing Platform for Mass Screening Purposes of Both Pediatric and Adult Cohorts), which is not on this map. Cited by 98 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 2 pooled it
–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.

NCT06939556 recruitingnot on this mapstarted 2025, after this paper: background citation

Development of a High-throughput Serological Testing Platform for Mass Screening Purposes of Both Pediatric and Adult Cohorts

TypeobservationalSponsorIstituto Zooprofilattico Sperimentale delle VenezieRan2025 to 2025Enrolled152ConditionsDiagnostics, Pandemic Response
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Carleen Klumpp-ThomasNational Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.ORCID 0000-0002-6646-6132
Heather KalishTrans-NIH Shared Resource on Biomedical Engineering and Physical Science, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
Matthew DrewProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Sally HunsbergerBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.
Kelly SneadProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Michael P FayBiostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.ORCID 0000-0002-8643-9625
Jennifer MehalkoProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Anandakumar ShunmugavelSection on Immuno-Engineering, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
Vanessa WallProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Peter FrankProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
John-Paul DensonProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Min HongProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Gulcin GultenProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Simon MessingProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Jennifer HicksTrans-NIH Shared Resource on Biomedical Engineering and Physical Science, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA.
Sam MichaelNational Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.
William GilletteProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Matthew D HallNational Center for Advancing Translational Sciences, National Institutes of Health, Rockville, MD, 20850, USA.
Matthew J MemoliLID Clinical Studies Unit, Laboratory of Infectious Diseases, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, 20894, USA.ORCID 0000-0001-6393-5178
Dominic EspositoProtein Expression Laboratory, NCI RAS Initiative, Frederick National Laboratory for Cancer Research, Frederick, MD, 21702, USA.
Kaitlyn SadtlerSection on Immuno-Engineering, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, MD, 20894, USA. kaitlyn.sadtler@nih.gov.ORCID 0000-0003-2587-8330

Funding

Research Services Section (RSS)ZICTR000242 · NCATS · NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES · PI WILSON, KELLI · 2015 to 2025
$64.9M
Micro Analytical ImmunochemistryZICEB000076 · NIBIB · NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING · PI KALISH, HEATHER · 2011 to 2025
$6.3M
ImmunoengineeringZIAEB000093 · NIBIB · NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING · PI SADTLER, KAITLYN · 2020 to 2025
$5.5M
Coronavirus Pathogenesis and Broadly Protective Vaccine DevelopmentZIAAI001268 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MEMOLI, MATTHEW · 2020 to 2025
$4.8M
CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

The extent of SARS-CoV-2 infection throughout the United States population is currently unknown. High quality serology is key to avoiding medically costly diagnostic errors, as well as to assuring properly informed public health decisions. Here, we present an optimized ELISA-based serology protocol, from antigen production to data analyses, that helps define thresholds for IgG and IgM seropositivity with high specificities. Validation of this protocol is performed using traditionally collected serum as well as dried blood on mail-in blood sampling kits. Archival (pre-2019) samples are used as negative controls, and convalescent, PCR-diagnosed COVID-19 patient samples serve as positive controls. Using this protocol, minimal cross-reactivity is observed for the spike proteins of MERS, SARS1, OC43 and HKU1 viruses, and no cross reactivity is observed with anti-influenza A H1N1 HAI. Our protocol may thus help provide standardized, population-based data on the extent of SARS-CoV-2 seropositivity, immunity and infection.

Indexed as

COVID-19 TestingAntibodies, ViralCOVID-19COVID-19 Nucleic Acid TestingCOVID-19 Serological TestingEnzyme-Linked Immunosorbent AssayHumansImmunoglobulin GImmunoglobulin MPandemicsReference StandardsSARS-CoV-2Sensitivity and SpecificitySpike Glycoprotein, CoronavirusAntibodies, ViralImmunoglobulin GImmunoglobulin MSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID33397956
PMCPMC7782755

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.