Evidence map›Paper›PMID 35692032›Full record

ArticleJournal of clinical laboratory analysis2022

Development and evaluation of time-resolved fluorescent immunochromatographic assay for quantitative detection of SARS-CoV-2 spike antigen.

Buzhou Xu, Hao Tang, Yiming Weng, Valerie Sloane Jones, Shuhong Luo, Chih Yun Cho, Yongping Lin, Jianmin Fang, Xuedong Song, Ruo-Pan Huang

Abstract read
In one paragraph

Article in Journal of clinical laboratory analysis, 2022. 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
–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

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.

  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.

Buzhou XuRayBiotech, Guangzhou, Guangzhou, China.
Hao TangRayBiotech, Guangzhou, Guangzhou, China.
Yiming WengRayBiotech, Guangzhou, Guangzhou, China.
Valerie Sloane JonesRayBiotech Life, Peachtree Corners, Georgia, USA.ORCID https://orcid.org/0000-0002-4204-9959
Shuhong LuoRayBiotech, Guangzhou, Guangzhou, China.
Chih Yun ChoRayBiotech Life, Peachtree Corners, Georgia, USA.
Yongping LinThe First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Jianmin FangRayBiotech, Guangzhou, Guangzhou, China.
Xuedong SongRayBiotech, Guangzhou, Guangzhou, China.
Ruo-Pan HuangRayBiotech, Guangzhou, Guangzhou, China.ORCID https://orcid.org/0000-0002-5884-8026

Funding

Guangdong Province Key Technologies R&D Program for "Precision Medicine and Stem Cells" 2019B020227004Guangdong Province Key Technologies R&D Program for "Precision Medicine and Stem Cells" 2019B020231002Guangzhou Basic and Applied Basic Research Project 202002030242Guangzhou Innovation Leadership Team CXLJTD-201602Industry-University-Research Collaborative Innovation Special Project of Guangzhou 201802030001National Science and Technology Major Project of China 2018ZX10732-401-003-012Pearl River S&T Nova Program of Guangzhou 201806010032Pearl River S&T Nova Program of Guangzhou 201806010035RayBiotech innovative research fund
6 · The paper itself

Abstract

backgroundThe spread of COVID-19 worldwide caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has necessitated efficient, sensitive diagnostic methods to identify infected people. We report on the development of a rapid 15-minute time-resolved fluorescent (TRF) lateral flow immunochromatographic assay for the quantitative detection of the SARS-CoV-2 spike protein receptor-binding domain (S1-RBD).

objectivesOur objective was to develop an efficient method of detecting SARS-CoV-2 within 15 min of sample collection.

methodsWe constructed and evaluated a portable, disposable lateral flow device, which detected the S1-RBD protein directly in nasopharyngeal swab samples. The device emits a fluorescent signal in the presence of S1-RBD, which can be captured by an automated TRF instrument.

resultsThe TRF lateral flow assay signal was linear from 0 to 20 ng/ml and demonstrated high accuracy and reproducibility. When evaluated with clinical nasopharyngeal swabs, the assay was performed at >80% sensitivity, >84% specificity, and > 82% accuracy for detection of the S1-RBD antigen.

conclusionThe new S1-RBD antigen test is a rapid (15 min), sensitive, and specific assay that requires minimal sample preparation. Critically, the assay correlated closely with PCR-based methodology in nasopharyngeal swab samples, showing that the detected S1-RBD antigen levels correlate with SARS-CoV-2 virus load. Therefore, the new TRF lateral flow test for S1-RBD has potential application in point-of-care settings.

Indexed as

COVID-19SARS-CoV-2Antibodies, ViralHumansImmunoassayReproducibility of ResultsSpike Glycoprotein, CoronavirusAntibodies, ViralSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2COVID-19RT-PCRSARS-CoV-2Spike proteintime-resolved fluorescenceTRF lateral flow

Identifiers

PMID35692032
PMCPMC9279991

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LicenceCC BY
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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.