Evidence map›Paper›PMID 33775672›Full record

Trial reportJournal of immunological methods2021

Validation of a combined ELISA to detect IgG, IgA and IgM antibody responses to SARS-CoV-2 in mild or moderate non-hospitalised patients.

A M Cook, S E Faustini, L J Williams, A F Cunningham, M T Drayson, A M Shields, D Kay, L Taylor, T Plant, A Huissoon and 9 more

Open access · greenAbstract readClinical TrialValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of immunological methods, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.1field-weighted citation impact, top 7% 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

24 citing papers in PubMed, 47 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Observational
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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 at 4 institutions in 1 country.

A M CookThe Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
S E FaustiniClinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
L J WilliamsThe Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK. Electronic address: Leigh.Williams@bindingsite.com.
A F CunninghamInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
M T DraysonClinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
A M ShieldsClinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
D KayThe Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
L TaylorThe Royal Wolverhampton NHS Trust, Wolverhampton Road, Wolverhampton, West Midlands WV10 0QP, UK.
T PlantClinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK.
A HuissoonInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
G WallisThe Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
S BeckUniversity Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
S E JossiInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
M Perez-ToledoInstitute of Immunology and Immunotherapy, University of Birmingham, Birmingham B15 2TT, UK.
M L NewbySchool of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
J D AllenSchool of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
M CrispinSchool of Biological Sciences, University of Southampton, Southampton SO17 1BJ, UK.
S HardingThe Binding Site Group Ltd, 8 Calthorpe Road, Birmingham B15 1QT, UK.
A G RichterClinical Immunology Service, University of Birmingham College of Medical and Dental Sciences, Birmingham B15 2TT, UK; University Hospitals Birmingham, NHS Foundation Trust, Birmingham B15 2GW, UK.
University of Birmingham · GBUniversity of Southampton · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBThe Royal Wolverhampton NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFrequently SARS-CoV-2 results in mild or moderate disease with potentially lower concentrations of antibodies compared to those that are hospitalised. Here, we validated an ELISA using SARS-CoV-2 trimeric spike glycoprotein, with targeted detection of IgG, IgA and IgM (IgGAM) using serum and dried blood spots (DBS) from adults with mild or moderate disease.

methodsTargeting the SARS-CoV-2 trimeric spike, a combined anti-IgG, IgA and IgM serology ELISA assay was developed using 62 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 624 COVID-19 negative samples. The assay was validated using 73 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 359 COVID-19 negative serum samples with an additional 81 DBSs. The assay was further validated in 226 PCR-confirmed non-hospitalised, mild or moderate COVID-19 samples, ≥14 days post symptom onset and 426 COVID-19 negative clinical samples.

resultsA sensitivity and specificity of 98.6% (95% CI, 92.6-100.0), 98.3% (95% CI, 96.4-99.4), respectively, was observed following validation of the SARS-CoV-2 ELISA. No cross-reactivities with endemic coronaviruses or other human viruses were observed, and no change in results were recorded for interfering substances. The assay was stable at temperature extremes and components were stable for 15 days once opened. A matrix comparison showed DBS to correlate with serum results. Clinical validation of the assay reported a sensitivity of 94.7% (95% CI, 90.9-97.2%) and a specificity of 98.4% (95% CI, 96.6-99.3%).

conclusionsThe human anti-IgGAM SARS-CoV-2 ELISA provides accurate and sensitive detection of SARS-CoV-2 antibodies in non-hospitalised adults with mild or moderate disease. The use of dried blood spots makes the assay accessible to the wider community.

Indexed as

COVID-19COVID-19 Serological TestingAdultAntibodies, ViralEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin AImmunoglobulin GImmunoglobulin MMaleMiddle AgedSARS-CoV-2Antibodies, ViralImmunoglobulin AImmunoglobulin GImmunoglobulin MCOVID-19Dried blood spotLow prevalenceMild diseaseSerologicalTrimeric spike protein

Identifiers

PMID33775672
PMCPMC7997147
OpenAlexW3150122045

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.