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Performance evaluation of a non-invasive one-step multiplex RT-qPCR assay for detection of SARS-CoV-2 direct from saliva

Jenkins, Harry H; Lopez, Ana A Tellechea; Tarantini, Francesco Saverio; Tomlin, Hannah; Scales, Danielle; Lee, I-Ning; Wu, Siyu; Hyde, Ralph; Lis-Slimak, Katarzyna; Byaruhanga, Timothy; Thompson, Jamie L; Pijuan-Galito, Sara; Doolan, Lara; Kaneko, Kazuyo; Gwynne, Penny; Reffin, Caroline; Park, Emily; Dey, Jayasree; Hill, Jack; Arendt-Tranholm, Asta; Stroud, Amy; Petrie, Moira; Denning, Chris; Benest, Andrew V; Seedhouse, Claire

Performance evaluation of a non-invasive one-step multiplex RT-qPCR assay for detection of SARS-CoV-2 direct from saliva Thumbnail


Authors

Harry H Jenkins

Ana A Tellechea Lopez

Francesco Saverio Tarantini

Hannah Tomlin

Danielle Scales

I-NING LEE I-NING.LEE@NOTTINGHAM.AC.UK
Research Fellow

Siyu Wu

Ralph Hyde

Katarzyna Lis-Slimak

Timothy Byaruhanga

Jamie L Thompson

Sara Pijuan-Galito

Lara Doolan

Kazuyo Kaneko

Penny Gwynne

Caroline Reffin

Emily Park

Jayasree Dey

Jack Hill

Asta Arendt-Tranholm

Amy Stroud

Moira Petrie

CHRIS DENNING chris.denning@nottingham.ac.uk
Professor of Stem Cell Biology

Andrew V Benest



Abstract

Polymerase chain reaction (PCR) has proven to be the gold-standard for SARS-CoV-2 detection in clinical settings. The most common approaches rely on nasopharyngeal specimens obtained from swabs, followed by RNA extraction, reverse transcription and quantitative PCR. Although swab-based PCR is sensitive, swabbing is invasive and unpleasant to administer, reducing patient compliance for regular testing and resulting in an increased risk of improper sampling. To overcome these obstacles, we developed a non-invasive one-step RT-qPCR assay performed directly on saliva specimens. The University of Nottingham Asymptomatic Testing Service protocol simplifies sample collection and bypasses the need for RNA extraction, or additives, thus helping to encourage more regular testing and reducing processing time and costs. We have evaluated the assay against the performance criteria specified by the UK regulatory bodies and attained accreditation (BS EN ISO/IEC 17,025:2017) for SARS-CoV-2 diagnostic testing by the United Kingdom Accreditation Service. We observed a sensitivity of 1 viral copy per microlitre of saliva, and demonstrated a concordance of > 99.4% between our results and those of other accredited testing facilities. We concluded that saliva is a stable medium that allows for a highly precise, repeatable, and robust testing method.

Journal Article Type Article
Acceptance Date Jun 27, 2022
Online Publication Date Jul 7, 2022
Publication Date Jul 1, 2022
Deposit Date Nov 17, 2022
Publicly Available Date Nov 25, 2022
Journal Scientific Reports
Electronic ISSN 2045-2322
Peer Reviewed Peer Reviewed
Volume 12
Issue 1
Article Number 11553
DOI https://doi.org/10.1038/s41598-022-15616-6
Keywords Nasopharynx, Saliva, Humans, RNA, Viral, Specimen Handling, Clinical Laboratory Techniques, Sensitivity and Specificity, COVID-19, SARS-CoV-2, COVID-19 Testing
Public URL https://nottingham-repository.worktribe.com/output/10071740
PMID 35798820

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