Evidence map›Paper›PMID 34331707›Full record

ArticleJournal of medical virology2021

Evaluation of a SARS-CoV-2 antigen-detecting rapid diagnostic test as a self-test: Diagnostic performance and usability.

Nino Guy Cassuto, Anne Gravier, Mathilda Colin, Aurelie Theillay, Daniela Pires-Roteira, Sandra Pallay, Raphael Serreau, Laurent Hocqueloux, Thierry Prazuck

Abstract readMulticenter Study
In one paragraph

Article in Journal of medical virology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 3 pooled it
–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

15 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Nino Guy CassutoLaboratoires Drouot, Paris, France.
Anne GravierCentre Gratuit d'Information, de Dépistage et de Diagnostic (CeGIDD) Orléans, Centre Hospitalier Régional d'Orléans, Orléans, France.
Mathilda ColinCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.
Aurelie TheillayCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.
Daniela Pires-RoteiraCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.
Sandra PallayCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.
Raphael SerreauService de Médecine Préventive, Orléans Métropole, Orléans, France.
Laurent HocquelouxCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.
Thierry PrazuckCentre Hospitalier Régional d'Orléans, Service des Maladies Infectieuses et Tropicales, Orléans, France.ORCID http://orcid.org/0000-0002-2212-6873

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To control the spread of the coronavirus disease 2019 (COVID-19) epidemics, it is necessary to have easy-to-use, reliable diagnostic tests available. The nasopharyngeal sampling method being often uncomfortable, nasal sampling could prove to be a viable alternative to the reference sampling method. We performed a multicentre, prospective validation study of the COVID-VIRO® test, using a nasal swab sampling method, in a point-of-care setting. In addition, we performed a multicentre, prospective, and usability study to validate the use of the rapid antigen nasal diagnostic test by laypersons. In March 2021, 239 asymptomatic and symptomatic patients were included in the validation study. Compared with reverse-transcription polymerase chain reaction on nasopharyngeal samples, the sensitivity and specificity of the COVID-VIRO® Antigen test combined with a nasal sampling method were evaluated as 96.88% and 100%, respectively. A total of 101 individuals were included in the usability study. Among these, 99% of the participants rated the instructions material as good, 98% of the subjects executed the test procedure well, and 98% of the participants were able to correctly interpret the test results. This study validates the relevance of COVID-VIRO® as a diagnostic tool from nasal specimens as well as its usability in the general population. COVID-VIRO® diagnostic performances and ease of use make it suitable for widespread utilization.

Indexed as

Self-TestingAdultAntigens, ViralCOVID-19 TestingDiagnostic Tests, RoutineHumansMalePoint-of-Care TestingProspective StudiesSARS-CoV-2Sensitivity and SpecificityAntigens, Viralantigen testingCOVID-19diagnostic testingnasal samplingSARS-CoV-2self-testusability

Identifiers

PMID34331707
PMCPMC8426870

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.