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. 2020 Dec;75(12):1082-1088.
doi: 10.1136/thoraxjnl-2020-215732. Epub 2020 Aug 12.

Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey

Barnaby Flower #  1   2 , Jonathan C Brown #  3 , Bryony Simmons  3 , Maya Moshe  3 , Rebecca Frise  3 , Rebecca Penn  3 , Ruthiran Kugathasan  3 , Claire Petersen  4 , Anna Daunt  3   4 , Deborah Ashby  5 , Steven Riley  5 , Christina Joanne Atchison  2   5 , Graham P Taylor  3 , Sutha Satkunarajah  6 , Lenny Naar  6 , Robert Klaber  4 , Anjna Badhan  3 , Carolina Rosadas  3 , Maryam Khan  3 , Natalia Fernandez  3 , Macià Sureda-Vives  7 , Hannah M Cheeseman  3 , Jessica O'Hara  3 , Gianluca Fontana  6 , Scott J C Pallett  8   9 , Michael Rayment  9 , Rachael Jones  9 , Luke S P Moore  9   10 , Myra O McClure  3 , Peter Cherepanov  3 , Richard Tedder  3 , Hutan Ashrafian  11 , Robin Shattock  3 , Helen Ward  2   5 , Ara Darzi  2   6 , Paul Elliot  2   12 , Wendy S Barclay #  3 , Graham S Cooke #  3   2
Affiliations

Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey

Barnaby Flower et al. Thorax. 2020 Dec.

Abstract

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.

Keywords: clinical epidemiology; respiratory infection; viral infection.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

Figure 1
Figure 1
Sensitivity of lateral flow immunoassays with (A) finger-prick (self-read), (B) finger-prick (observer read) and (C) serum in laboratory compared with (1) PCR-confirmed cases or (2) individuals testing positive with at least one of two laboratory assays (spike protein ELISA and hybrid spike protein receptor binding domain double antigen bridging assay).
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