Evidence map›Paper›PMID 37478103›Full record

Trial reportPloS one2023

Evaluation of the diagnostic accuracy of two point-of-care tests for COVID-19 when used in symptomatic patients in community settings in the UK primary care COVID diagnostic accuracy platform trial (RAPTOR-C19).

Brian D Nicholson, Philip J Turner, Thomas R Fanshawe, Alice J Williams, Gayatri Amirthalingam, Sharon Tonner, Maria Zambon, Richard Body, Kerrie Davies, Rafael Perera and 4 more

Open access · goldAbstract readClinical TrialAdaptive Clinical Trial
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

14 authors at 5 institutions in 1 country.

Brian D NicholsonNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-0661-7362
Philip J TurnerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.ORCID 0000-0001-7299-8939
Thomas R FanshaweNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
Alice J WilliamsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.ORCID 0000-0003-4612-1468
Gayatri AmirthalingamImmunisation and Vaccine Preventable Diseases Division and Public Health Programmes, UK Health Security Agency, London, United Kingdom.
Sharon TonnerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
Maria ZambonInfluenza and Respiratory Virology & Polio Reference Service, UK Health Security Agency, London, United Kingdom.
Richard BodyDivision of Cardiovascular Science, University of Manchester, Manchester, United Kingdom.ORCID 0000-0001-9089-8130
Kerrie DaviesHealthcare Associated Infections Research Group, Leeds Teaching Hospitals NHS trust and University of Leeds, Leeds, United Kingdom.
Rafael PereraNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
Simon de LusignanNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.ORCID 0000-0002-8553-2641
Gail N HaywardNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
F D Richard HobbsNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
RAPTOR-C19 Study Group and the CONDOR Steering Committee
University of Oxford · GBManchester Metropolitan University · GBNIHR Imperial Biomedical Research Centre · GBUK Health Security Agency · GBUniversity of Leeds · GB

Funding

Department of Health 495Department of Health ACF-2019-13-009Department of Health COV0051Department of Health NIHR300738Wellcome Trust
6 · The paper itself

Abstract

BACKGROUND AND

objectivePoint-of-care lateral flow device antigen testing has been used extensively to identify individuals with active SARS-CoV-2 infection in the community. This study aimed to evaluate the diagnostic accuracy of two point-of-care tests (POCTs) for SARS-CoV-2 in routine community care.

methodsAdults and children with symptoms consistent with suspected current COVID-19 infection were prospectively recruited from 19 UK general practices and two COVID-19 testing centres between October 2020 and October 2021. Participants were tested by trained healthcare workers using at least one of two index POCTs (Roche-branded SD Biosensor Standard™ Q SARS-CoV-2 Rapid Antigen Test and/or BD Veritor™ System for Rapid Detection of SARS-CoV-2). The reference standard was laboratory triplex reverse transcription quantitative PCR (RT-PCR) using a combined nasal/oropharyngeal swab. Diagnostic accuracy parameters were estimated, with 95% confidence intervals (CIs), overall, in relation to RT-PCR cycle threshold and in pre-specified subgroups.

resultsOf 663 participants included in the primary analysis, 39.2% (260/663, 95% CI 35.5% to 43.0%) had a positive RT-PCR result. The SD Biosensor POCT had sensitivity 84.0% (178/212, 78.3% to 88.6%) and specificity 98.5% (328/333, 96.5% to 99.5%), and the BD Veritor POCT had sensitivity 76.5% (127/166, 69.3% to 82.7%) and specificity 98.8% (249/252, 96.6% to 99.8%) compared with RT-PCR. Sensitivity of both devices dropped substantially at cycle thresholds ≥30 and in participants more than 7 days after onset of symptoms.

conclusionsBoth POCTs assessed exceed the Medicines and Healthcare products Regulatory Agency target product profile's minimum acceptable specificity of 95%. Confidence intervals for both tests include the minimum acceptable sensitivity of 80%. In symptomatic patients, negative results on these two POCTs do not preclude the possibility of infection. Tests should not be expected to reliably detect disease more than a week after symptom onset, when viral load may be reduced. REGISTRATION: ISRCTN142269.

Indexed as

COVID-19AdultChildCOVID-19 TestingHumansPoint-of-Care TestingPrimary Health CareSARS-CoV-2Sensitivity and SpecificityUnited Kingdom

Identifiers

PMID37478103
PMCPMC10361479
OpenAlexW4385064799

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.