{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T20:15:44Z","timestamp":1762460144280,"version":"3.37.3"},"reference-count":24,"publisher":"BMJ","license":[{"start":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T00:00:00Z","timestamp":1605052800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"abstract":"<jats:title>Abstract<\/jats:title>\n                    <jats:sec>\n                        <jats:title>Objective<\/jats:title>\n                        <jats:p>To assess the accuracy of the AbC-19 Rapid Test lateral flow\n                            immunoassay for the detection of previous severe acute respiratory\n                            syndrome coronavirus 2 (SARS-CoV-2) infection.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Design<\/jats:title>\n                        <jats:p>Test accuracy study.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Setting<\/jats:title>\n                        <jats:p>Laboratory based evaluation.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Participants<\/jats:title>\n                        <jats:p>2847 key workers (healthcare staff, fire and rescue officers, and\n                            police officers) in England in June 2020 (268 with a previous polymerase\n                            chain reaction (PCR) positive result (median 63 days previously), 2579\n                            with unknown previous infection status); and 1995 pre-pandemic blood\n                            donors.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Main outcome measures<\/jats:title>\n                        <jats:p>AbC-19 sensitivity and specificity, estimated using known negative\n                            (pre-pandemic) and known positive (PCR confirmed) samples as reference\n                            standards and secondly using the Roche Elecsys anti-nucleoprotein assay,\n                            a highly sensitive laboratory immunoassay, as a reference standard in\n                            samples from key workers.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Results<\/jats:title>\n                        <jats:p>Test result bands were often weak, with positive\/negative\n                            discordance by three trained laboratory staff for 3.9% of devices. Using\n                            consensus readings, for known positive and negative samples sensitivity\n                            was 92.5% (95% confidence interval 88.8% to 95.1%) and specificity was\n                            97.9% (97.2% to 98.4%). Using an immunoassay reference standard,\n                            sensitivity was 94.2% (90.7% to 96.5%) among PCR confirmed cases but\n                            84.7% (80.6% to 88.1%) among other people with antibodies. This is\n                            consistent with AbC-19 being more sensitive when antibody concentrations\n                            are higher, as people with PCR confirmation tended to have more severe\n                            disease whereas only 62% (218\/354) of seropositive participants had had\n                            symptoms. If 1 million key workers were tested with AbC-19 and 10% had\n                            actually been previously infected, 84\u2009700 true positive and 18\u2009900 false\n                            positive results would be projected. The probability that a positive\n                            result was correct would be 81.7% (76.8% to 85.8%).<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Conclusions<\/jats:title>\n                        <jats:p>AbC-19 sensitivity was lower among unselected populations than among\n                            PCR confirmed cases of SARS-CoV-2, highlighting the scope for\n                            overestimation of assay performance in studies involving only PCR\n                            confirmed cases, owing to \u201cspectrum bias.\u201d Assuming that 10% of the\n                            tested population have had SARS-CoV-2 infection, around one in five key\n                            workers testing positive with AbC-19 would be false positives.<\/jats:p>\n                    <\/jats:sec>\n                    <jats:sec>\n                        <jats:title>Study registration<\/jats:title>\n                        <jats:p>ISRCTN 56609224.<\/jats:p>\n                    <\/jats:sec>","DOI":"10.1136\/bmj.m4262","type":"journal-article","created":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T15:06:55Z","timestamp":1676905615000},"page":"m4262","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":25,"title":["Accuracy of UK Rapid Test Consortium (UK-RTC) \u201cAbC-19 Rapid Test\u201d for\n                        detection of previous SARS-CoV-2 infection in key workers: test accuracy\n                        study"],"prefix":"10.1136","clinical-trial-number":[{"clinical-trial-number":"nct56609224","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct90871183","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ranya","family":"Mulchandani","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hayley E","family":"Jones","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sian","family":"Taylor-Phillips","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Justin","family":"Shute","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith","family":"Perry","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shabnam","family":"Jamarani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tim","family":"Brooks","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andre","family":"Charlett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Hickman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabel","family":"Oliver","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Kaptoge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Danesh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emanuele","family":"Di Angelantonio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony E","family":"Ades","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9155-6228","authenticated-orcid":false,"given":"David H","family":"Wyllie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,11,11]]},"reference":[{"key":"2023021710172642000_371.nov11_8.m4262.1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-0897-1"},{"key":"2023021710172642000_371.nov11_8.m4262.2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD013652"},{"key":"2023021710172642000_371.nov11_8.m4262.3","article-title":"Usability and acceptability of home-based self-testing for SARS-CoV-2 antibodies for population surveillance","author":"Atchison","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2023021710172642000_371.nov11_8.m4262.4","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2020-215732"},{"key":"2023021710172642000_371.nov11_8.m4262.5","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiaa352"},{"key":"2023021710172642000_371.nov11_8.m4262.6","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m3325"},{"key":"2023021710172642000_371.nov11_8.m4262.7","unstructured":"Medicine & Healthcare products Regulatory Agency.\n                            Target Product Profile: antibody tests to help determine if people have\n                            immunity to SARS-CoV-2: Version 2. 2020.\n                            https:\/\/www.gov.uk\/government\/publications\/how-tests-and-testing-kits-for-coronavirus-covid-19-work\/target-product-profile-antibody-tests-to-help-determine-if-people-have-recent-infection-to-sars-cov-2-version-2."},{"key":"2023021710172642000_371.nov11_8.m4262.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2020.05.023"},{"key":"2023021710172642000_371.nov11_8.m4262.9","unstructured":"US Food and Drug Administration. FAQs on Testing for\n                            SARS-CoV-2. 2020.\n                            https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/faqs-testing-sars-cov-2."},{"key":"2023021710172642000_371.nov11_8.m4262.10","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2005.048595"},{"key":"2023021710172642000_371.nov11_8.m4262.11","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.11.1061"},{"key":"2023021710172642000_371.nov11_8.m4262.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM197810262991705"},{"key":"2023021710172642000_371.nov11_8.m4262.13","doi-asserted-by":"publisher","DOI":"10.1038\/s41564-020-00813-8"},{"key":"2023021710172642000_371.nov11_8.m4262.14","doi-asserted-by":"crossref","unstructured":"Ripperger TJ Uhrlaub JL Watanabe M . Detection,\n                            prevalence, and duration of humoral responses to SARS-CoV-2 under\n                            conditions of limited population exposure. 2020.\n                            https:\/\/www.medrxiv.org\/content\/10.1101\/2020.08.14.20174490v1\n                            .","DOI":"10.1101\/2020.08.14.20174490"},{"key":"2023021710172642000_371.nov11_8.m4262.15","doi-asserted-by":"publisher","DOI":"10.1101\/2020.08.19.20178186"},{"key":"2023021710172642000_371.nov11_8.m4262.16","unstructured":"Robertson LJ Moore JS Blighe K . SARS-CoV-2 antibody\n                            testing in a UK population: detectable IgG for up to 20 weeks post\n                            infection. 2020.\n                            https:\/\/www.medrxiv.org\/content\/10.1101\/2020.09.29.20201509v1."},{"key":"2023021710172642000_371.nov11_8.m4262.17","unstructured":"Public Health England Nuffield Department of\n                            Medicine, University of Oxford Oxford University Hospitals NHS\n                            Foundation Trust . Evaluation of sensitivity and specificity of four\n                            commercially available SARS-CoV-2 antibody immunassays. Public Health\n                            England, 2020."},{"key":"2023021710172642000_371.nov11_8.m4262.18","unstructured":"World Health Organization. WHO protocol for\n                            performance laboratory evaluation of HCV serology assays. 2017.\n                            https:\/\/www.who.int\/diagnostics_laboratory\/evaluations\/alter\/171219_protocol_pqdx_040_v6_hcv.pdf?ua=1."},{"key":"2023021710172642000_371.nov11_8.m4262.19","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc2025179"},{"key":"2023021710172642000_371.nov11_8.m4262.20","doi-asserted-by":"publisher","DOI":"10.1101\/2020.04.25.20074856"},{"key":"2023021710172642000_371.nov11_8.m4262.21","doi-asserted-by":"publisher","DOI":"10.12688\/wellcomeopenres.15927.1"},{"key":"2023021710172642000_371.nov11_8.m4262.22","doi-asserted-by":"publisher","DOI":"10.1101\/2020.04.09.20056325"},{"key":"2023021710172642000_371.nov11_8.m4262.23","unstructured":"Abingdon Health. Preliminary report of an independent\n                            evaluation of AbC-19. 2020.\n                            https:\/\/www.abingdonhealth.com\/preliminary-report-independent-evaluation-abc19\/."},{"key":"2023021710172642000_371.nov11_8.m4262.24","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a112510"}],"container-title":["BMJ"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/data.bmj.org\/tdm\/10.1136\/bmj.m4262","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmj.m4262","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T15:07:10Z","timestamp":1676905630000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj.m4262"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11,11]]},"references-count":24,"alternative-id":["10.1136\/bmj.m4262"],"URL":"https:\/\/doi.org\/10.1136\/bmj.m4262","relation":{},"ISSN":["1756-1833"],"issn-type":[{"type":"electronic","value":"1756-1833"}],"subject":[],"published":{"date-parts":[[2020,11,11]]}}}