Evidence map›Paper›PMID 34260271›Full record

ArticleJournal of clinical microbiology2021

Early Laboratory Diagnosis of COVID-19 by Antigen Detection in Blood Samples of the SARS-CoV-2 Nucleocapsid Protein.

Rebekka F Thudium, Malene P Stoico, Estrid Høgdall, Julie Høgh, Henrik B Krarup, Margit A H Larsen, Poul H Madsen, Susanne D Nielsen, Sisse R Ostrowski, Amanda Palombini and 2 more

Open access · greenAbstract read
In one paragraph

Article in Journal of clinical microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.2field-weighted citation impact, top 10% 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

19 citing papers in PubMed, 40 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

12 authors at 2 institutions in 1 country.

Rebekka F ThudiumUniversity of Copenhagen, Rigshospitalet, Department of Infectious Diseases, Copenhagen, Denmark.
Malene P StoicoAalborg University Hospital, Department of Molecular Diagnostics, Aalborg, Denmark.
Estrid HøgdallBio- and Genome Bank Denmark, Department of Pathology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev, Denmark.
Julie HøghUniversity of Copenhagen, Rigshospitalet, Department of Infectious Diseases, Copenhagen, Denmark.
Henrik B KrarupAalborg University Hospital, Department of Molecular Diagnostics, Aalborg, Denmark.
Margit A H LarsenUniversity of Copenhagen, Rigshospitalet, Department of Clinical Immunology, Copenhagen, Denmark.
Poul H MadsenAalborg University Hospital, Department of Molecular Diagnostics, Aalborg, Denmark.
Susanne D NielsenUniversity of Copenhagen, Rigshospitalet, Department of Infectious Diseases, Copenhagen, Denmark.
Sisse R OstrowskiUniversity of Copenhagen, Rigshospitalet, Department of Clinical Immunology, Copenhagen, Denmark.
Amanda PalombiniSolsten Diagnostics International, Aarhus, Denmark.
Daniel B RasmussenUniversity of Copenhagen, Rigshospitalet, Department of Infectious Diseases, Copenhagen, Denmark.
Niels T FogedSolsten Diagnostics International, Aarhus, Denmark.ORCID 0000-0002-3522-4560
University of Copenhagen · DKAalborg University Hospital · DK

Funding

Danish Council for Independent Research - Medical Sciences (FSS)Eureka Network Call for COVID-19 0221-00005Innovation Fund Denmark 0173-00085Novo Nordisk Fonden (NNF)Rigshospitalet Research Council
6 · The paper itself

Abstract

The purpose of this study was to characterize the diagnostic performance of a newly developed enzyme-linked immunosorbent assay (ELISA) for detection of SARS-CoV-2 nucleocapsid protein (NP) in blood. Blood samples were collected during hospitalization of 165 inpatients with PCR-confirmed SARS-CoV-2 infection and from 505 outpatients predominantly with relevant symptoms of COVID-19 simultaneously with PCR testing. For the 143 inpatients who had their first blood sample collected within 2 weeks after PCR-confirmed infection, the diagnostic sensitivity of the ELISA was 91.6%. The mean NP concentration of the 131 ELISA-positive blood samples was 1,734 pg/ml (range, 10 to 3,840 pg/ml). An exponential decline in NP concentration was observed for 368 blood samples collected over the first 4 weeks after PCR-confirmed SARS-CoV-2 infection, and all blood samples taken later had an NP concentration below the 10-pg/ml diagnostic cutoff. The diagnostic sensitivity of the ELISA was 81.4% for the 43 blood samples collected from outpatients with a simultaneous positive PCR test, and the mean NP concentration of the 35 ELISA-positive samples was 157 pg/ml (range, 10 to 1,377 pg/ml). For the 462 outpatients with a simultaneous negative PCR test, the diagnostic specificity of the ELISA was 99.8%. In conclusion, the SARS-CoV-2 NP ELISA is a suitable laboratory diagnostic test for COVID-19, particularly for hospitals, where blood samples are readily available and screening of serum or plasma by ELISA can facilitate prevention of nosocomial infections and reduce the requirement for laborious swab sampling and subsequent PCR analysis to confirmatory tests only.

Indexed as

COVID-19SARS-CoV-2Antibodies, ViralClinical Laboratory TechniquesEnzyme-Linked Immunosorbent AssayHumansLaboratoriesNucleocapsid ProteinsSensitivity and SpecificityAntibodies, ViralNucleocapsid ProteinsCOVID-19diagnosticsnucleocapsid proteinSARS-CoV-2

Identifiers

PMID34260271
PMCPMC8451432
OpenAlexW3178732926

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.