Evidence map›Paper›PMID 37894080›Full record

ArticleMicroorganisms2023

SARS-CoV-2 Rapid Antigen Test Based on a New Anti-Nucleocapsid Protein Monoclonal Antibody: Development and Real-Time Validation.

Fabiana Fioravante Coelho, Miriam Aparecida da Silva, Thiciany Blener Lopes, Juliana Moutinho Polatto, Natália Salazar de Castro, Luis Adan Flores Andrade, Karine Lima Lourenço, Hugo Itaru Sato, Alex Fiorini de Carvalho, Helena Perez Coelho and 17 more

Open access · goldAbstract read
In one paragraph

Article in Microorganisms, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

27 authors at 3 institutions in 1 country.

Fabiana Fioravante CoelhoFaculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte 31270-901, Brazil.
Miriam Aparecida da SilvaInstituto Butantan, São Paulo 05503-900, Brazil.
Thiciany Blener LopesCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.
Juliana Moutinho PolattoInstituto Butantan, São Paulo 05503-900, Brazil.
Natália Salazar de CastroCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.
Luis Adan Flores AndradeCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0003-1601-5816
Karine Lima LourençoCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0001-6090-4253
Hugo Itaru SatoCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.
Alex Fiorini de CarvalhoCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0003-4372-5282
Helena Perez CoelhoCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0001-6176-0378
Flávia Fonseca BagnoCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0003-1578-6678
Daniela LuzInstituto Butantan, São Paulo 05503-900, Brazil.ORCID 0000-0001-9622-0320
Vincent Louis VialaInstituto Butantan, São Paulo 05503-900, Brazil.
Pedro Queiroz CattonyInstituto Butantan, São Paulo 05503-900, Brazil.
Bruna de Sousa MeloInstituto Butantan, São Paulo 05503-900, Brazil.
Ana Maria MoroInstituto Butantan, São Paulo 05503-900, Brazil.ORCID 0000-0002-0650-7764
Wagner QuintilioInstituto Butantan, São Paulo 05503-900, Brazil.ORCID 0000-0002-3382-8184
Ana Paula BarbosaInstituto Butantan, São Paulo 05503-900, Brazil.ORCID 0000-0003-0045-6828
Camila Gasque BomfimDepartment of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.ORCID 0000-0002-7367-2153
Camila Pereira SoaresDepartment of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.
Cristiane Rodrigues GuzzoDepartment of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.ORCID 0000-0002-5664-8055
Flavio Guimarães FonsecaCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.ORCID 0000-0002-1416-8694
Edison Luiz DurigonDepartment of Microbiology, Institute of Biomedical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.ORCID 0000-0003-4898-6553
Ricardo Tostes GazzinelliCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.
Santuza M Ribeiro TeixeiraCentro de Tecnologia em Vacinas, Universidade Federal de Minas Gerais, Belo Horizonte 31310-260, Brazil.
Roxane Maria Fontes PiazzaInstituto Butantan, São Paulo 05503-900, Brazil.ORCID 0000-0003-0068-8506
Ana Paula FernandesFaculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte 31270-901, Brazil.
Universidade Federal de Minas Gerais · BRInstituto Butantan · BRUniversidade de São Paulo · BR

Funding

Financiadora de Estudos e Projetos 01.20.0005.00Financiadora de Estudos e Projetos 01.20.0039.00National Council for Scientific and Technological Development 403549/2020-5
6 · The paper itself

Abstract

SARS-CoV-2 diagnostic tests have become an important tool for pandemic control. Among the alternatives for COVID-19 diagnosis, antigen rapid diagnostic tests (Ag-RDT) are very convenient and widely used. However, as SARS-CoV-2 variants may continuously emerge, the replacement of tests and reagents may be required to maintain the sensitivity of Ag-RDTs. Here, we describe the development and validation of an Ag-RDT during an outbreak of the Omicron variant, including the characterization of a new monoclonal antibody (anti-DTC-N 1B3 mAb) that recognizes the Nucleocapsid protein (N). The anti-DTC-N 1B3 mAb recognized the sequence TFPPTEPKKDKKK located at the C-terminus of the N protein of main SARS-CoV-2 variants of concern. Accordingly, the Ag-RDT prototypes using the anti-DTC-N 1B3 mAB detected all the SARS-CoV-2 variants-Wuhan, Alpha, Gamma, Delta, P2 and Omicron. The performance of the best prototype (sensitivity of 95.2% for samples with Ct ≤ 25; specificity of 98.3% and overall accuracy of 85.0%) met the WHO recommendations. Moreover, results from a patients' follow-up study indicated that, if performed within the first three days after onset of symptoms, the Ag-RDT displayed 100% sensitivity. Thus, the new mAb and the Ag-RDT developed herein may constitute alternative tools for COVID-19 point-of-care diagnosis and epidemiological surveillance.

Indexed as

Ag-RDT developmentdiagnosisfollow-up studyIgG2b monoclonal antibodynucleocapsid (N) antigenSARS-CoV-2validation

Identifiers

PMID37894080
PMCPMC10608853
OpenAlexW4387119625

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.