Evidence map›Paper›PMID 37752417›Full record

ArticleBMC immunology2023

The development of a highly sensitive and quantitative SARS-CoV-2 rapid antigen test applying newly developed monoclonal antibodies to an automated chemiluminescent flow-through membrane immunoassay device.

Kengo Nishimura, Hiroaki Kitazawa, Takashi Kawahata, Kosuke Yuhara, Takahiro Masuya, Toshihiro Kuroita, Kentarou Waki, Seiichi Koike, Masaharu Isobe, Nobuyuki Kurosawa

Open access · goldAbstract read
In one paragraph

Article in BMC immunology, 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

10 authors at 2 institutions in 1 country.

Kengo NishimuraBio-Science & Medical Research Unit, Corporate Research Center, TOYOBO CO., LTD., 2-1-1 Katata, Otsu-Shi, Shiga, 520-0243, Japan.
Hiroaki KitazawaBiotechnology Research Laboratory, TOYOBO CO., LTD., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
Takashi KawahataBiotechnology Research Laboratory, TOYOBO CO., LTD., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
Kosuke YuharaBiotechnology Research Laboratory, TOYOBO CO., LTD., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
Takahiro MasuyaBiotechnology Research Laboratory, TOYOBO CO., LTD., 10-24, Toyo-Cho, Tsuruga-Shi, Fukui, 914-8550, Japan.
Toshihiro KuroitaBiotechnology Operating Department, TOYOBO CO., LTD., 1-13-1 Umeda, Kita-Ku, Osaka, 530-0001, Japan.
Kentarou WakiLaboratory of Molecular and Cellular Biology, Graduate School of Science and Engineering for Education, University of Toyama, Toyama-Shi, Gofuku, Toyama, 930-8555, Japan.
Seiichi KoikeLaboratory of Molecular and Cellular Biology, Graduate School of Innovative Life Science, University of Toyama, 3190 Gofuku, Toyama-Shi, Toyama, 930-8555, Japan.
Masaharu IsobeLaboratory of Molecular and Cellular Biology, Graduate School of Innovative Life Science, University of Toyama, 3190 Gofuku, Toyama-Shi, Toyama, 930-8555, Japan.
Nobuyuki KurosawaLaboratory of Molecular and Cellular Biology, Graduate School of Innovative Life Science, University of Toyama, 3190 Gofuku, Toyama-Shi, Toyama, 930-8555, Japan. kurosawa@eng.u-toyama.ac.jp.
Toyobo (Japan) · JPUniversity of Toyama · JP

Funding

Japan Agency for Medical Research and Development 19187977Japan Society for the Promotion of Science 21K07214Japan Society for the Promotion of Science 22H02875
6 · The paper itself

Abstract

backgroundRapid and accurate diagnosis of individuals with SARS-CoV-2 infection is an effective way to prevent and control the spread of COVID-19. Although the detection of SARS-CoV-2 viral RNA by RT-qPCR is the gold standard for COVID-19 testing, the use of antigen-detecting rapid diagnostic tests (Ag-RDTs) is emerging as a complementary surveillance tool as Omicron case numbers skyrocket worldwide. However, the results from Ag-RDTs are less accurate in individuals with low viral loads.

resultsTo develop a highly sensitive and accurate Ag-RDT, 90 monoclonal antibodies were raised from guinea pigs immunized with SARS CoV-2 nucleocapsid protein (CoV-2-NP). By applying a capture antibody recognizing the structural epitope of the N-terminal domain of CoV-2-NP and a detection antibody recognizing the C-terminal tail of CoV-2-NP to an automated chemiluminescence flow-through membrane immunoassay device, we developed a novel Ag-RDT, CoV-2-POCube. The CoV-2-POCube exclusively recognizes CoV-2-NP variants but not the nucleocapsid proteins of other human coronaviruses. The CoV-2-POCube achieved a limit of detection sensitivity of 0.20 ~ 0.66 pg/mL of CoV-2-NPs, demonstrating more than 100 times greater sensitivity than commercially available SARS-CoV-2 Ag-RDTs.

conclusionsCoV-2-POCube has high analytical sensitivity and can detect SARS-CoV-2 variants in 15 min without observing the high-dose hook effect, thus meeting the need for early SARS-CoV-2 diagnosis with lower viral load. CoV-2-POCube is a promising alternative to currently available diagnostic devices for faster clinical decision making in individuals with suspected COVID-19 in resource-limited settings.

Indexed as

Antibodies, MonoclonalCOVID-19AnimalsCOVID-19 TestingGuinea PigsHumansImmunoassaySARS-CoV-2Sensitivity and SpecificityAntibodies, MonoclonalCOVID-19Lateral flow immunochromatographyMonoclonal antibodyOmicronPoint-of-care testRapid antigen testSARS-CoV-2

Identifiers

PMID37752417
PMCPMC10523765
OpenAlexW4387047252

What OpenQuestion holds

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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.