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@article{Flower:2020:10.1136/thoraxjnl-2020-215732,
author = {Flower, B and Brown, JC and Simmons, B and Moshe, M and Frise, R and Penn, R and Kugathasan, R and Petersen, C and Daunt, A and Ashby, D and Riley, S and Atchison, C and Taylor, GP and Satkunarajah, S and Naar, L and Klaber, R and Badhan, A and Rosadas, C and Kahn, M and Fernandez, N and Sureda-Vives, M and Cheeseman, H and O'Hara, J and Fontana, G and Pallett, SJC and Rayment, M and Jones, R and Moore, LSP and Cherapanov, P and Tedder, R and McClure, M and Ashrafian, H and Shattock, R and Ward, H and Darzi, A and Elliott, P and Barclay, W and Cooke, G},
doi = {10.1136/thoraxjnl-2020-215732},
journal = {Thorax},
pages = {1082--1088},
title = {Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 sero-prevalence survey},
url = {http://dx.doi.org/10.1136/thoraxjnl-2020-215732},
volume = {75},
year = {2020}
}

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TY  - JOUR
AB  - BackgroundAccurate antibody tests are essential to monitor the SARS-CoV-2 pandemic. Lateral flow immunoassays (LFIAs) can deliver testing at scale. However, reported performance varies, and sensitivity analyses have generally been conducted on serum from hospitalised patients. For use in community testing, evaluation of finger-prick self-tests, in non-hospitalised individuals, is required.MethodsSensitivity analysis was conducted on 276 non-hospitalised participants. All had tested positive for SARS-CoV-2 by RT-PCR and were ≥21d from symptom-onset. In phase I we evaluated five LFIAs in clinic (with finger-prick) and laboratory (with blood and sera) in comparison to a) PCR-confirmed infection and b) presence of SARS-CoV-2 antibodies on two “in-house” ELISAs. Specificity analysis was performed on 500 pre-pandemic sera. In phase II, six additional LFIAs were assessed with serum.Findings95% (95%CI [92.2, 97.3]) of the infected cohort had detectable antibodies on at least one ELISA. LFIA sensitivity was variable, but significantly inferior to ELISA in 8/11 assessed. Of LFIAs assessed in both clinic and laboratory, finger-prick self-test sensitivity varied from 21%-92% vs PCR-confirmed cases and 22%-96% vs composite ELISA positives. Concordance between finger-prick and serum testing was at best moderate (kappa 0.56) and, at worst, slight (kappa 0.13). All LFIAs had high specificity (97.2% - 99.8%).InterpretationLFIA sensitivity and sample concordance is variable, highlighting the importance of evaluations in setting of intended use. This rigorous approach to LFIA evaluation identified a test with high specificity (98.6% (95%CI [97.1, 99.4])), moderate sensitivity (84.4% with fingerprick (95%CI [70.5, 93.5])), and moderate concordance, suitable for seroprevalence surveys.
AU  - Flower,B
AU  - Brown,JC
AU  - Simmons,B
AU  - Moshe,M
AU  - Frise,R
AU  - Penn,R
AU  - Kugathasan,R
AU  - Petersen,C
AU  - Daunt,A
AU  - Ashby,D
AU  - Riley,S
AU  - Atchison,C
AU  - Taylor,GP
AU  - Satkunarajah,S
AU  - Naar,L
AU  - Klaber,R
AU  - Badhan,A
AU  - Rosadas,C
AU  - Kahn,M
AU  - Fernandez,N
AU  - Sureda-Vives,M
AU  - Cheeseman,H
AU  - O'Hara,J
AU  - Fontana,G
AU  - Pallett,SJC
AU  - Rayment,M
AU  - Jones,R
AU  - Moore,LSP
AU  - Cherapanov,P
AU  - Tedder,R
AU  - McClure,M
AU  - Ashrafian,H
AU  - Shattock,R
AU  - Ward,H
AU  - Darzi,A
AU  - Elliott,P
AU  - Barclay,W
AU  - Cooke,G
DO  - 10.1136/thoraxjnl-2020-215732
EP  - 1088
PY  - 2020///
SN  - 0040-6376
SP  - 1082
TI  - Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 sero-prevalence survey
T2  - Thorax
UR  - http://dx.doi.org/10.1136/thoraxjnl-2020-215732
UR  - https://thorax.bmj.com/content/75/12/1082
UR  - http://hdl.handle.net/10044/1/81321
VL  - 75
ER  -

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