Evidence map›Paper›PMID 34407759›Full record

SynthesisBMC infectious diseases2021

A systematic review of the sensitivity and specificity of lateral flow devices in the detection of SARS-CoV-2.

Dylan A Mistry, Jenny Y Wang, Mika-Erik Moeser, Thomas Starkey, Lennard Y W Lee

Open access · goldAbstract readSystematic Review
In one paragraph

Synthesis in BMC infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 5 pooled it
6.1field-weighted citation impact, top 3% 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

62 citing papers in PubMed, 5 syntheses or guidelines pooled it, 114 citations in OpenAlex.

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2 more citing papers are in PubMed but not listed here.

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

5 authors at 3 institutions in 1 country.

Dylan A MistryOxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK. dylan.mistry@nhs.net.
Jenny Y WangUniversity of Oxford, Oxford, UK.
Mika-Erik MoeserUniversity of Oxford, Oxford, UK.
Thomas StarkeyInstitute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Lennard Y W LeeOxford University Hospitals, Headley Way, Headington, Oxford, OX3 9DU, UK.
University of Birmingham · GBUniversity of Oxford · GBOxford University Hospitals NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLateral flow devices (LFDs) are viral antigen tests for the detection of SARS-CoV-2 that produce a rapid result, are inexpensive and easy to operate. They have been advocated for use by the World Health Organisation to help control outbreaks and break the chain of transmission of COVID-19 infections. There are now several studies assessing their accuracy but as yet no systematic review. Our aims were to assess the sensitivity and specificity of LFDs in a systematic review and summarise the sensitivity and specificity of these tests.

methodsA targeted search of Pubmed and Medxriv, using PRISMA principles, was conducted identifying clinical studies assessing the sensitivity and specificity of LFDs as their primary outcome compared to reverse transcriptase polymerase chain reaction (RT-PCR) for the detection of SARS-CoV-2. Based on extracted data sensitivity and specificity was calculated for each study. Data was pooled based on manufacturer of LFD and split based on operator (self-swab or by trained professional) and sensitivity and specificity data were calculated.

resultsTwenty-four papers were identified involving over 26,000 test results. Sensitivity from individual studies ranged from 37.7% (95% CI 30.6-45.5) to 99.2% (95% CI 95.5-99.9) and specificity from 92.4% (95% CI 87.5-95.5) to 100.0% (95% CI 99.7-100.0). Operation of the test by a trained professional or by the test subject with self-swabbing produced comparable results.

conclusionsThis systematic review identified that the performance of lateral flow devices is heterogeneous and dependent on the manufacturer. Some perform with high specificity but a great range of sensitivities were shown (38.32-99.19%). Test performance does not appear dependent on the operator. Potentially, LFDs could support the scaling up of mass testing to aid track and trace methodology and break the chain of transmission of COVID-19 with the additional benefit of providing individuals with the results in a much shorter time frame.

Indexed as

Antigens, ViralCOVID-19COVID-19 TestingFalse Negative ReactionsFalse Positive ReactionsFemaleHumansMalePandemicsReverse Transcriptase Polymerase Chain ReactionRNA, ViralSARS-CoV-2Sensitivity and SpecificityAntigens, ViralRNA, ViralCoronavirusCOVID-19Lateral flow deviceLateral flow testMass testingPopulation testingRapid antigen detectionReverse transcriptase polymerase chain reactionSARS-CoV-2Viral antigen detection

Identifiers

PMID34407759
PMCPMC8371300
OpenAlexW3137437197

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.