PT - JOURNAL ARTICLE AU - Barnaby Flower AU - Jonathan C Brown AU - Bryony Simmons AU - Maya Moshe AU - Rebecca Frise AU - Rebecca Penn AU - Ruthiran Kugathasan AU - Claire Petersen AU - Anna Daunt AU - Deborah Ashby AU - Steven Riley AU - Christina Joanne Atchison AU - Graham P Taylor AU - Sutha Satkunarajah AU - Lenny Naar AU - Robert Klaber AU - Anjna Badhan AU - Carolina Rosadas AU - Maryam Khan AU - Natalia Fernandez AU - Macià Sureda-Vives AU - Hannah M Cheeseman AU - Jessica O'Hara AU - Gianluca Fontana AU - Scott J C Pallett AU - Michael Rayment AU - Rachael Jones AU - Luke S P Moore AU - Myra O McClure AU - Peter Cherepanov AU - Richard Tedder AU - Hutan Ashrafian AU - Robin Shattock AU - Helen Ward AU - Ara Darzi AU - Paul Elliot AU - Wendy S Barclay AU - Graham S Cooke TI - Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey AID - 10.1136/thoraxjnl-2020-215732 DP - 2020 Aug 12 TA - Thorax PG - thoraxjnl-2020-215732 4099 - http://thorax.bmj.com/content/early/2020/08/11/thoraxjnl-2020-215732.short 4100 - http://thorax.bmj.com/content/early/2020/08/11/thoraxjnl-2020-215732.full AB - Background Accurate 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.Methods Sensitivity analysis was conducted on 276 non-hospitalised participants. All had tested positive for SARS-CoV-2 by reverse transcription PCR and were ≥21 days from symptom onset. In phase I, we evaluated five LFIAs in clinic (with finger prick) and laboratory (with blood and sera) in comparison to (1) PCR-confirmed infection and (2) presence of SARS-CoV-2 antibodies on two ‘in-house’ ELISAs. Specificity analysis was performed on 500 prepandemic sera. In phase II, six additional LFIAs were assessed with serum.Findings 95% (95% CI 92.2% to 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 out of 11 assessed. Of LFIAs assessed in both clinic and laboratory, finger-prick self-test sensitivity varied from 21% to 92% versus PCR-confirmed cases and from 22% to 96% versus 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%).Interpretation LFIA 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% to 99.4%)), moderate sensitivity (84.4% with finger prick (95% CI 70.5% to 93.5%)) and moderate concordance, suitable for seroprevalence surveys.