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@article{Gibani:2020:10.1016/S2666-5247(20)30121-X,
author = {Gibani, MM and Toumazou, C and Sohbati, M and Sahoo, R and Karvela, M and Hon, T-K and De, Mateo S and Burdett, A and Leung, KYF and Barnett, J and Orbeladze, A and Luan, S and Pournias, S and Sun, J and Flower, B and Bedzo-Nutakor, J and Amran, M and Quinlan, R and Skolimowska, K and Herrera, C and Rowan, A and Badhan, A and Klaber, R and Davies, G and Muir, D and Randell, P and Crook, D and Taylor, GP and Barclay, W and Mughal, N and Moore, LSP and Jeffery, K and Cooke, GS},
doi = {10.1016/S2666-5247(20)30121-X},
journal = {The Lancet Microbe},
pages = {e300--e307},
title = {Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study.},
url = {http://dx.doi.org/10.1016/S2666-5247(20)30121-X},
volume = {1},
year = {2020}
}

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TY  - JOUR
AB  - Background: Access to rapid diagnosis is key to the control and management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory RT-PCR testing is the current standard of care but usually requires a centralised laboratory and significant infrastructure. We describe our diagnostic accuracy assessment of a novel, rapid point-of-care real time RT-PCR CovidNudge test, which requires no laboratory handling or sample pre-processing. Methods: Between April and May, 2020, we obtained two nasopharyngeal swab samples from individuals in three hospitals in London and Oxford (UK). Samples were collected from three groups: self-referred health-care workers with suspected COVID-19; patients attending emergency departments with suspected COVID-19; and hospital inpatient admissions with or without suspected COVID-19. For the CovidNudge test, nasopharyngeal swabs were inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as sample adequacy control. Swab samples were tested in parallel using the CovidNudge platform, and with standard laboratory RT-PCR using swabs in viral transport medium for processing in a central laboratory. The primary analysis was to compare the sensitivity and specificity of the point-of-care CovidNudge test with laboratory-based testing. Findings: We obtained 386 paired samples: 280 (73%) from self-referred health-care workers, 15 (4%) from patients in the emergency department, and 91 (23%) hospital inpatient admissions. Of the 386 paired samples, 67 tested positive on the CovidNudge point-of-care platform and 71 with standard laboratory RT-PCR. The overall sensitivity of the point-of-care test compared with laboratory-based testing was 94% (95% CI 86-98) with an overall specificity of 100% (99-100). The sensitivity of the test varied
AU  - Gibani,MM
AU  - Toumazou,C
AU  - Sohbati,M
AU  - Sahoo,R
AU  - Karvela,M
AU  - Hon,T-K
AU  - De,Mateo S
AU  - Burdett,A
AU  - Leung,KYF
AU  - Barnett,J
AU  - Orbeladze,A
AU  - Luan,S
AU  - Pournias,S
AU  - Sun,J
AU  - Flower,B
AU  - Bedzo-Nutakor,J
AU  - Amran,M
AU  - Quinlan,R
AU  - Skolimowska,K
AU  - Herrera,C
AU  - Rowan,A
AU  - Badhan,A
AU  - Klaber,R
AU  - Davies,G
AU  - Muir,D
AU  - Randell,P
AU  - Crook,D
AU  - Taylor,GP
AU  - Barclay,W
AU  - Mughal,N
AU  - Moore,LSP
AU  - Jeffery,K
AU  - Cooke,GS
DO  - 10.1016/S2666-5247(20)30121-X
EP  - 307
PY  - 2020///
SN  - 2666-5247
SP  - 300
TI  - Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study.
T2  - The Lancet Microbe
UR  - http://dx.doi.org/10.1016/S2666-5247(20)30121-X
UR  - https://www.ncbi.nlm.nih.gov/pubmed/32964211
UR  - https://www.sciencedirect.com/science/article/pii/S266652472030121X?via%3Dihub
UR  - http://hdl.handle.net/10044/1/82918
VL  - 1
ER  -

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