Evidence map›Paper›PMID 34376716›Full record

ArticleScientific reports2021

Clinical validation of optimised RT-LAMP for the diagnosis of SARS-CoV-2 infection.

Boon Lim, Jeremy Ratcliff, Dorota A Nawrot, Yejiong Yu, Harshmeena R Sanghani, Chia-Chen Hsu, Leon Peto, Simon Evans, Susanne H Hodgson, Aikaterini Skeva and 12 more

Open access · goldAbstract readValidation Study
In one paragraph

Article in Scientific reports, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.1field-weighted citation impact, top 13% 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

16 citing papers in PubMed, 28 citations in OpenAlex.

  1. Biology methods & protocols · 2026
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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

22 authors at 6 institutions in 2 countries.

Boon Lim *Department of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Jeremy Ratcliff *Peter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, OX1 3SY, UK.
Dorota A Nawrot *Department of Pharmacology, University of Oxford, Mansfield Road, Oxford, UK.
Yejiong YuDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Harshmeena R SanghaniDepartment of Pharmacology, University of Oxford, Mansfield Road, Oxford, UK.
Chia-Chen HsuDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Leon PetoDepartment of Microbiology, Oxford University NHS Foundation Trust, Oxford, UK.
Simon EvansDepartment of Microbiology, Oxford University NHS Foundation Trust, Oxford, UK.
Susanne H HodgsonDepartment of Microbiology, Oxford University NHS Foundation Trust, Oxford, UK.
Aikaterini SkevaDemocritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupoli, Greece.
Maria AdamDemocritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupoli, Greece.
Maria PanopoulouDemocritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupoli, Greece.
Christos E ZoisDemocritus University of Thrace, University Hospital of Alexandroupolis, Alexandroupoli, Greece.
Katy PoncinSir William Dunn School of Pathology, University of Oxford, Oxford, UK.
Sridhar R VasudevanDepartment of Pharmacology, University of Oxford, Mansfield Road, Oxford, UK.
Siqi DaiDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Shuai RenDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Hong ChangOxford Suzhou Centre for Advanced Research (OSCAR), University of Oxford, Suzhou, China.
Zhanfeng CuiDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK.
Peter SimmondsPeter Medawar Building for Pathogen Research, Nuffield Department of Medicine, University of Oxford, Oxford, OX1 3SY, UK.
Wei E HuangDepartment of Engineering Science, University of Oxford, Parks Road, Oxford, OX1 3PJ, UK. wei.huang@eng.ox.ac.uk.
Monique I AnderssonDepartment of Microbiology, Oxford University NHS Foundation Trust, Oxford, UK. Monique.Andersson@ndcls.ox.ac.uk.
University of Oxford · GBUniversity Hospital of Alexandroupolis · GROxford Health NHS Foundation Trust · GBDemocritus University of Thrace · GRJenner Institute · GBMedawar Building for Pathogen Research · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We have optimised a reverse transcription-loop-mediated isothermal amplification (RT-LAMP) assay for the detection of SARS-CoV-2 from extracted RNA for clinical application. We improved the stability and reliability of the RT-LAMP assay by the addition of a temperature-dependent switch oligonucleotide to reduce self- or off-target amplification. We then developed freeze-dried master mix for single step RT-LAMP reaction, simplifying the operation for end users and improving long-term storage and transportation. The assay can detect as low as 13 copies of SARS-CoV2 RNA per reaction (25-μL). Cross reactivity with other human coronaviruses was not observed. We have applied the new RT-LAMP assay for testing clinical extracted RNA samples extracted from swabs of 72 patients in the UK and 126 samples from Greece and demonstrated the overall sensitivity of 90.2% (95% CI 83.8-94.7%) and specificity of 92.4% (95% CI 83.2-97.5%). Among 115 positive samples which Ct values were less than 34, the RT-LAMP assay was able to detect 110 of them with 95.6% sensitivity. The specificity was 100% when RNA elution used RNase-free water. The outcome of RT-LAMP can be reported by both colorimetric detection and quantifiable fluorescent reading. Objective measures with a digitized reading data flow would allow for the sharing of results for local or national surveillance.

Indexed as

COVID-19 Nucleic Acid TestingHumansMolecular Diagnostic TechniquesNucleic Acid Amplification TechniquesSensitivity and Specificity

Identifiers

PMID34376716
PMCPMC8355225
OpenAlexW3186230226

What OpenQuestion holds

Textmetadata
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.