Evidence map›Paper›PMID 33529223›Full record

ArticlePloS one2021

Development and performance evaluation of a rapid in-house ELISA for retrospective serosurveillance of SARS-CoV-2.

Bijon Kumar Sil, Nowshin Jahan, Md Ahsanul Haq, Mumtarin Jannat Oishee, Tamanna Ali, Shahad Saif Khandker, Eiry Kobatake, Masayasu Mie, Mohib Ullah Khondoker, Mohd Raeed Jamiruddin and 1 more

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.0field-weighted citation impact, top 12% 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

22 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Article
  6. COVID-19 diagnostics: Molecular biology to nanomaterials.Clinica chimica acta; international journal of clinical chemistry · 2023
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

11 authors at 4 institutions in 2 countries.

Bijon Kumar SilGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Nowshin JahanGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Md Ahsanul HaqGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Mumtarin Jannat OisheeGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Tamanna AliGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Shahad Saif KhandkerGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Eiry KobatakeDepartment of Life Science and Technology, Tokyo Institute of Technology, Yokohama, Japan.
Masayasu MieDepartment of Life Science and Technology, Tokyo Institute of Technology, Yokohama, Japan.
Mohib Ullah KhondokerGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Mohd Raeed JamiruddinGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.
Nihad AdnanGonoshasthaya-RNA Molecular Diagnostic & Research Center, Dhanmondi, Dhaka, Bangladesh.ORCID 0000-0002-4999-4793
Gono University · BDTokyo Institute of Technology · JPBRAC University · BDJahangirnagar University · BD

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the ongoing pandemic situation of COVID-19, serological tests can complement the molecular diagnostic methods, and can be one of the important tools of sero-surveillance and vaccine evaluation.

aimTo develop and evaluate a rapid SARS-CoV-2 specific ELISA for detection of anti-SARS-CoV2 IgG from patients' biological samples.

methodsIn order to develop this ELISA, three panels of samples (n = 184) have been used: panel 1 (n = 19) and panel 2 (n = 60) were collected from RT-PCR positive patients within 14 and after 14 days of onset of clinical symptoms, respectively; whereas panel 3 consisted of negative samples (n = 105) collected either from healthy donors or pre-pandemic dengue patients. As a capturing agent full-length SARS-CoV2 specific recombinant nucleocapsid was immobilized. Commercial SARS-CoV2 IgG kit based on chemiluminescent assay was used for the selection of samples and optimization of the assay. The threshold cut-off point, inter-assay and intra-assay variations were determined.

resultsThe incubation/reaction time was set at a total of 30 minutes with the sensitivity of 84% (95% confidence interval, CI, 60.4%, 96.6%) and 98% (95% CI, 91.1%, 100.0%), for panel 1 and 2, respectively; with overall 94.9% sensitivity (95% CI 87.5%, 98.6%). Moreover, the clinical specificity was 97.1% (95% CI, 91.9%, 99.4%) with no cross reaction with dengue samples. The overall positive and negative predictive values are 96.2% (95% CI 89.2%, 99.2%) and 96.2% (95% CI, 90.6% 99.0%), respectively. In-house ELISA demonstrated 100% positive and negative percent agreement with Elecsys Anti-SARS-CoV-2, with Cohen's kappa value of 1.00 (very strong agreement), while comparing 13 positive and 17 negative confirmed cases.

conclusionThe assay is rapid and can be applied as one of the early and retrospective sero-monitoring tools in all over the affected areas.

Indexed as

Antibodies, ViralCoronavirus Nucleocapsid ProteinsCOVID-19Enzyme-Linked Immunosorbent AssayHumansImmunoglobulin GPhosphoproteinsSARS-CoV-2Sensitivity and SpecificityAntibodies, ViralCoronavirus Nucleocapsid ProteinsImmunoglobulin Gnucleocapsid phosphoprotein, SARS-CoV-2Phosphoproteins

Identifiers

PMID33529223
PMCPMC7853452
OpenAlexW3128767281

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.