Evidence map›Paper›PMID 35305688›Full record

ArticleVirology journal2022

Sensitive and specific serological ELISA for the detection of SARS-CoV-2 infections.

Ji Luo, Alexandra Brakel, Andor Krizsan, Tobias Ludwig, Marina Mötzing, Daniela Volke, Nicole Lakowa, Thomas Grünewald, Claudia Lehmann, Johannes Wolf and 6 more

Open access · goldAbstract read
In one paragraph

Article in Virology journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 5% 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

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

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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

16 authors at 5 institutions in 1 country.

Ji LuoInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Alexandra BrakelInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Andor KrizsanInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Tobias LudwigInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Marina MötzingInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Daniela VolkeInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Nicole LakowaClinic for Infectious Diseases and Tropical Medicine, Klinikum Chemnitz gGmbH, Chemnitz, Germany.
Thomas GrünewaldClinic for Infectious Diseases and Tropical Medicine, Klinikum Chemnitz gGmbH, Chemnitz, Germany.ORCID 0000-0002-2955-3085
Claudia LehmannInstitut für Transfusionsmedizin, Universitätsklinikum Leipzig, Leipzig, Germany.
Johannes WolfDepartment of Laboratory Medicine, Hospital St. Georg gGmbH, Leipzig, Germany.
Stephan BorteDepartment of Laboratory Medicine, Hospital St. Georg gGmbH, Leipzig, Germany.
Sanja Milkovska-StamenovaInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany.
Jörg GabertAdversis Pharma GmbH, Leipzig, Germany.
Felix FingasAdversis Pharma GmbH, Leipzig, Germany.
Markus ScholzInstitut für Medizinische Informatik, Statistik und Epidemiologie (IMISE), Universität Leipzig, Leipzig, Germany.
Ralf HoffmannInstitute of Bioanalytical Chemistry, Faculty of Chemistry and Mineralogy, Universität Leipzig, Leipzig, Germany. bioanaly@rz.uni-leipzig.de.ORCID 0000-0001-9932-5646
Leipzig University · DEKlinikum Chemnitz · DEKlinikum St. Georg · DELeipzig University of Applied Sciences · DEUniversity Hospital Leipzig · DE

Funding

Deutsche Forschungsgemeinschaft INST 268/387-1European Regional Development Fund 100523073
6 · The paper itself

Abstract

backgroundThe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has triggered the worldwide coronavirus disease 2019 (COVID-19) pandemic. Serological assays for the detection of SARS-CoV-2 infections are important to understand the immune response in patients and to obtain epidemiological data about the number of infected people, especially to identify asymptomatic persons not aware of a past infection.

methodsWe recombinantly produced SARS-CoV-2 nucleocapsid (N)-protein in Escherichia coli. We used the purified protein to develop an indirect enzyme-linked immunosorbent assay (ELISA) for the detection of SARS-CoV-2 specific antibodies. This ELISA method was optimized and validated with serum samples collected from 113 patients with RT-PCR-confirmed SARS-CoV-2 infections including hospitalized COVID-19 patients and 1500 control sera mostly collected before 2015 with different clinical background.

resultsThe optimized N-protein-ELISA provided a sensitivity of 89.7% (n = 68) for samples collected from patients with confirmed SARS-CoV-2 infections and mild to severe symptoms more than 14 days after symptom onset or a positive PCR test. The antibody levels remained low for serum samples collected in the first six days (n = 23) and increased in the second week (n = 22) post symptom onset or PCR confirmation. At this early phase, the ELISA provided a sensitivity of 39.1% and 86.4%, respectively, reflecting the time of an IgG immune response against pathogens. The assay specificity was 99.3% (n = 1500; 95% CI 0.995-0.999). Serum samples from persons with confirmed antibody titers against human immunodeficiency viruses 1/2, parvovirus B19, hepatitis A/B virus, cytomegalovirus, Epstein Barr virus, and herpes simplex virus were tested negative.

conclusionsWe conclude that the N-protein-based ELISA developed here is well suited for the sensitive and specific serological detection of SARS-CoV-2 specific IgG antibodies in human serum for symptomatic infections. It may also prove useful to identify previous SARS-CoV-2 infections in vaccinated people, as all currently approved vaccines rely on the SARS-CoV-2 spike (S-) protein.

Indexed as

COVID-19Epstein-Barr Virus InfectionsEnzyme-Linked Immunosorbent AssayHerpesvirus 4, HumanHumansNucleocapsid ProteinsSARS-CoV-2Nucleocapsid ProteinsCoronavirus disease 2019 (COVID-19)Enzyme-linked immunosorbent assay (ELISA)Nucleocapsid protein (N-protein)Serological testSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

Identifiers

PMID35305688
PMCPMC8934124
OpenAlexW4220967176

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.