Evidence map›Paper›PMID 40263514›Full record

ArticleScientific reports2025

Comparative evaluation of in-house ELISA and two commercial serological assays for the detection of antibodies against SARS-CoV-2.

Dabesa Gobena, Esayas Kebede Gudina, Tizta Tilahun Degfie, Tsinuel Girma, Getu Gebre, Alemseged Abdissa, Fikadu G Tafesse, Tesfaye Gelanew, Zeleke Mekonnen

Abstract readComparative Study
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

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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

2 citing papers in PubMed.

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4 · The record

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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

9 authors.

Dabesa GobenaPublic Health Emergency Management and Health Research Directorate, Oromia Health Bureau, Addis Ababa, Ethiopia. dabesagobena25@gmail.com.
Esayas Kebede GudinaDepartment of Internal Medicine, Institute of Health, Jimma University, Jimma, Ethiopia.
Tizta Tilahun DegfieFenot Project, School of Population and Public Health, Harvard University, Addis Ababa, Ethiopia.
Tsinuel GirmaFenot Project, School of Population and Public Health, Harvard University, Addis Ababa, Ethiopia.
Getu GebrePublic Health Emergency Management and Health Research Directorate, Oromia Health Bureau, Addis Ababa, Ethiopia.
Alemseged AbdissaArmauer Hanssen Research Institute, Addis Ababa, Ethiopia.
Fikadu G TafesseArmauer Hanssen Research Institute, Addis Ababa, Ethiopia.
Tesfaye GelanewArmauer Hanssen Research Institute, Addis Ababa, Ethiopia.
Zeleke MekonnenSchool of Medical Laboratory Science, Institute of Health, Jimma University, Jimma, Ethiopia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The in-house ELISA SARS-CoV-2 serological assay, developed by the Armauer Hansen Research Institute (AHRI) in Ethiopia, measures anti-SARS-CoV-2 receptor binding domain (RBD) antibodies. This study aimed to compare the performance of our cost-effective in-house ELISA with two established commercially available SARS-CoV-2 antibody detection assays during the pre-Omicron COVID-19 pandemic. In April 2021, serum samples were collected from 1441 students across 60 schools in Oromia, from 15 hotspot districts and towns. Socio-demographic data were gathered using CSentryCSProDataEntry7.2.1. Performance agreements between AHRI's in-house ELISA and the two commercial assays were analyzed in these serum samples. Statistical analyses, including Cohen's kappa (κ), overall percentage agreement, positive percent agreement (PPA), and negative percent agreement (NPA), were performed using STATA software. Diagnostic parameters were presented with 95% confidence intervals (CI), calculated using the Clopper-Pearson method. The performance comparison of the in-house ELISA showed substantial agreement with the two commercial assays. The overall concordance rate between in-house ELISA and Elecsys CLIA was 80.8% (95% CI 75.0-86.5), while the agreement between in-house ELISA and the Rapid LFA test (IgG + IgM) was 75.8% (95% CI 70.1-81.5). The kappa coefficients were: in-house ELISA vs. Elecsys CLIA (κ = 0.61, 95% CI 0.55-0.67), in-house ELISA vs. Rapid LFA test (IgG + IgM) (κ = 0.52, 95% CI 0.46-0.58), and Elecsys CLIA vs. Rapid LFA test (IgG + IgM) (κ = 0.73, 95% CI 0.67-0.78). The in-house ELISA demonstrated strong agreement with the Elecsys CLIA, showing a PPA of 81.7% and an NPA of 80.1%. Compared to the Rapid LFA test (IgG + IgM), which had a PPA of 83% and an NPA of 70.4%, the in-house ELISA exhibited better overall agreement with Elecsys CLIA. This study's findings indicate substantial agreement between the in-house ELISA and Elecsys. However, only modest agreement was observed between the in-house ELISA and the rapid test (IgG + IgM). Together, these results suggest the utility of the in-house ELISA as a cost-effective tool for sero surveillance studies and monitoring the effect of interventions in resource-poor settings.

Indexed as

Antibodies, ViralCOVID-19COVID-19 Serological TestingSARS-CoV-2AdolescentChildEnzyme-Linked Immunosorbent AssayEthiopiaFemaleHumansMaleSensitivity and SpecificityAntibodies, ViralCorcordanceEthiopiaIn-house ELISAPre-OmicronSerological assay

Identifiers

PMID40263514
PMCPMC12015421

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Registered trials

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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.