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

      , 1 , 2 , 1 , 1 , 1 , 1 , 1 , 1 , 3 , 1 , 3 , 4 , 4 , 2 , 4 , 1 , 5 , 5 , 3 , 1 , 1 , 1 , 1 , 6 , 1 , 1 , 5 , 7 , 8 , 8 , 8 , 8 , 9 , 1 , 1 , 1 , 10 , 1 , 2 , 4 , 2 , 5 , 2 , 11 , 1 , 1 , 2

      Thorax

      BMJ Publishing Group

      viral infection, clinical epidemiology, respiratory infection

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          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.

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          Most cited references 13

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          Is Open Access

          Distinct features of SARS-CoV-2-specific IgA response in COVID-19 patients

          In comparison to severe acute respiratory syndrome coronavirus (SARS-CoV), SARS-CoV-2 appears to be more contagious [1], and Coronavirus Disease 2019 (COVID-19) patients demonstrate varied clinical manifestations distinct from those seen in patients with SARS-CoV and middle east respiratory syndrome coronavirus (MERS-CoV) infections [2]. Collective results from the clinical and epidemiological observations suggest a distinct viral-host interaction in COVID-19 patients. Profiling of the antibody response during SARS-CoV-2 infection may help improve our understanding of the viral-host interaction and the immunopathological mechanisms of the disease.
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            • Record: found
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            Is Open Access

            Lateral flow-based antibody testing for Chlamydia trachomatis.

            We describe here a lateral flow-based assay (LFA) for the detection of antibodies against immunodominant antigen Pgp3 from Chlamydia trachomatis, the causative agent of urogenital chlamydia infection and ocular trachoma. Optimal signal detection was achieved when the gold-conjugate and test line contained Pgp3, creating a dual sandwich capture assay. The LFA yielded positive signals with serum and whole blood but not with eluted dried blood spots. For serum, the agreement of the LFA with the non-reference multiplex assay was 96%, the specificity using nonendemic pediatric sera was 100%, and the inter-rater agreement was κ=0.961. For whole blood, the agreement of LFA with multiplex was 81.5%, the specificity was 100%, and the inter-rater agreement was κ=0.940. The LFA was tested in a field environment and yielded similar results to those from laboratory-based testing. These data show the successful development of a lateral flow assay for detection of antibodies against Pgp3 with reliable use in field settings, which would make antibody-based testing for trachoma surveillance highly practical, especially after cessation of trachoma elimination programs.
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              • Record: found
              • Abstract: not found
              • Article: not found

              Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial

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                Author and article information

                Journal
                Thorax
                Thorax
                thoraxjnl
                thorax
                Thorax
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0040-6376
                1468-3296
                August 2020
                12 August 2020
                Affiliations
                [1 ] departmentDepartment of Infectious Disease, Faculty of Medicine , Imperial College London , London, UK
                [2 ] departmentNIHR BRC , Imperial College NHS Trust , London, UK
                [3 ] Imperial College Healthcare NHS Trust , London, UK
                [4 ] departmentDepartment of Epidemiology and Public Health , Imperial College London , London, UK
                [5 ] departmentInstitute of Global Health Innovation , Imperial College London , London, UK
                [6 ] departmentSynthetic Biology Group , MRC London Institute of Medical Sciences, Imperial College London , London, UK
                [7 ] departmentCentre for Defence Pathology , British Army , Birmingham, UK
                [8 ] Chelsea and Westminster Healthcare NHS Trust , London, UK
                [9 ] departmentNIHR Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance , Imperial College London , London, UK
                [10 ] departmentDepartment of Surgery and Cancer , Imperial College London , London, UK
                [11 ] departmentDepartment of Epidemiology and Biostatistics, School of Public Health , Imperial College London , London, United Kingdom
                Author notes
                [Correspondence to ] Dr Barnaby Flower, Infectious Disease, Department of Medicine, Imperial College London, London W2 1NY, UK; b.flower@ 123456imperial.ac.uk
                Article
                thoraxjnl-2020-215732
                10.1136/thoraxjnl-2020-215732
                7430184
                32796119
                © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

                This article is made freely available for use in accordance with BMJ’s website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

                Product
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100014013, UK Research and Innovation;
                Award ID: MC_PC_19078
                Funded by: FundRef http://dx.doi.org/10.13039/100013986, Government of the United Kingdom;
                Categories
                Respiratory Infection
                2474
                2313
                Original research
                Custom metadata
                free

                Surgery

                clinical epidemiology, respiratory infection, viral infection

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