Evidence map›Paper›PMID 40399889›Full record

Trial reportBMC infectious diseases2025

Diagnostic accuracy of non-invasive SARS-CoV-2 screening tests: a national prospective analysis.

Thomas Althaus, Alexandre Blake, Alizée Costantini, Christian Lavagna, Eva Jacquesson, Guillaume Groshenry, Alexa Troel, Bertrand Vanzo, Olivier Dejoux, Hervé Raps and 2 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05074745 (Severe Acute Respiratory Syndrome Coronavirus 2), which is not on this 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.

NCT05074745 naunknown statusnot on this map

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients: the CORDAGES Study

TypeinterventionalSponsorCentre Scientifique de MonacoRan2021 to 2021Enrolled1,500ConditionsSARS-CoV-2, COVID-19ArmsELISA POCT vs RT-PCR
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

12 authors.

Thomas AlthausDirectorate of Health Affairs, 48 boulevard d'Italie, Monaco, 98000, Monaco. talthaus@gouv.mc.
Alexandre BlakeIndependent Researcher, Durham, UK.
Alizée CostantiniCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Christian LavagnaCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Eva JacquessonCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Guillaume GroshenryCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Alexa TroelInterministerial Delegation for the Digital Transition, 2 rue du Gabian, Monaco, 98000, Monaco.
Bertrand VanzoInterministerial Delegation for the Digital Transition, 2 rue du Gabian, Monaco, 98000, Monaco.
Olivier DejouxCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Hervé RapsCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Patrick RampalCentre Scientifique de Monaco, 8 Quai Antoine 1er, Monaco, 98000, Monaco.
Eric J VoiglioDirectorate of Health Affairs, 48 boulevard d'Italie, Monaco, 98000, Monaco.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProviding non-invasive, accurate and affordable SARS-CoV-2 tests represents a public health priority, to better control the spread of the virus while protecting healthcare workers. Saliva is a robust alternative to nasopharyngeal (NP) swabs, but there is heterogeneity in collection and pre-analytical methods.

methodsRelying on a national COVID-19 Public Health Programme, we prospectively recruited 3,488 symptomatic and asymptomatic adults attending the Monaco community centre for NP RT-PCR testing from February 2021-2023. Saliva was concomitantly obtained with either a buccal swab or an oral sponge (OS) and analysed by an RT-PCR assay and a fully automated electrochemiluminescence enzyme immunoassay (ECLIA) rapid antigen test (RAT).

resultsThe sensitivity of the buccal RT-PCR varied according to previous SARS-CoV-2 infection, vaccination, and the presence of symptoms, while it remained around 95% for the OS RT-PCR. The specificity of the buccal RT-PCR approached 100% and was around 95% for the OS-RT PCR. The RAT sensitivity was 66.9% and 69.1% compared to NP and OS RT-PCR assays and increased to 71% and 97% in case of a high viral load (Ct < 25), respectively.

conclusionsRT-PCR assay using OS saliva showed high accuracy in symptomatic and non-symptomatic adults, including the identification of negative nasopharyngeal swabs. This method allows self-collection without any prior conditions for the patient nor laboratory pre-analytical steps. The ECLIA RAT offers high throughput but is only useful in individuals with high viral loads. Our findings encompassed the latest SARS-CoV-2 omicron subvariants, such as BA.4&5 and the XBB series.

trial registrationRegistry: ClinicalTrials.gov. REGISTRATION NUMBER: NCT05074745. Registration date: 12-10-2021.

Indexed as

COVID-19COVID-19 TestingSARS-CoV-2AdolescentAdultAgedCOVID-19 Nucleic Acid TestingCOVID-19 Serological TestingFemaleHumansMaleMass ScreeningMiddle AgedNasopharynxProspective StudiesSalivaDiagnostic accuracyOral spongeRapid antigen testRT-PCRSalivaSARS-CoV-2

Identifiers

PMID40399889
PMCPMC12096796

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.