{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,14]],"date-time":"2026-04-14T13:26:16Z","timestamp":1776173176439,"version":"3.50.1"},"reference-count":24,"publisher":"BMJ","license":[{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"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"],"accepted":{"date-parts":[[2022,7,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the performance of rapid antigen tests with unsupervised nasal and combined oropharyngeal and nasal self-sampling during the omicron period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Prospective cross sectional diagnostic test accuracy study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Three public health service covid-19 test sites in the Netherlands, 21 December 2021 to 10 February 2022.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>6497 people with covid-19 symptoms aged \u226516 years presenting for testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants had a swab sample taken for reverse transcription polymerase chain reaction (RT-PCR, reference test) and received one rapid antigen test to perform unsupervised using either nasal self-sampling (during the emergence of omicron, and when omicron accounted for &gt;90% of infections, phase 1) or with combined oropharyngeal and nasal self-sampling in a subsequent (phase 2; when omicron accounted for &gt;99% of infections). The evaluated tests were Flowflex (Acon Laboratories; phase 1 only), MPBio (MP Biomedicals), and Clinitest (Siemens-Healthineers).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The main outcomes were sensitivity, specificity, and positive and negative predictive values of each self-test, with RT-PCR testing as the reference standard.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      During phase 1, 45.0% (n=279) of participants in the Flowflex group, 29.1% (n=239) in the MPBio group, and 35.4% ((n=257) in the Clinitest group were confirmatory testers (previously tested positive by a self-test at own initiative). Overall sensitivities with nasal self-sampling were 79.0% (95% confidence interval 74.7% to 82.8%) for Flowflex, 69.9% (65.1% to 74.4%) for MPBio, and 70.2% (65.6% to 74.5%) for Clinitest. Sensitivities were substantially higher in confirmatory testers (93.6%, 83.6%, and 85.7%, respectively) than in those who tested for other reasons (52.4%, 51.5%, and 49.5%, respectively). Sensitivities decreased from 87.0% to 80.9% (P=0.16 by \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      test), 80.0% to 73.0% (P=0.60), and 83.1% to 70.3% (P=0.03), respectively, when transitioning from omicron accounting for 29% of infections to &gt;95% of infections. During phase 2, 53.0% (n=288) of participants in the MPBio group and 44.4% (n=290) in the Clinitest group were confirmatory testers. Overall sensitivities with combined oropharyngeal and nasal self-sampling were 83.0% (78.8% to 86.7%) for MPBio and 77.3% (72.9% to 81.2%) for Clinitest. When combined oropharyngeal and nasal self-sampling was compared with nasal self-sampling, sensitivities were found to be slightly higher in confirmatory testers (87.4% and 86.1%, respectively) and substantially higher in those testing for other reasons (69.3% and 59.9%, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Sensitivities of three rapid antigen tests with nasal self-sampling decreased during the emergence of omicron but was only statistically significant for Clinitest. Sensitivities appeared to be substantially influenced by the proportion of confirmatory testers. Sensitivities of MPBio and Clinitest improved after the addition of oropharyngeal to nasal self-sampling. A positive self-test result justifies prompt self-isolation without the need for confirmatory testing. Individuals with a negative self-test result should adhere to general preventive measures because a false negative result cannot be ruled out. Manufacturers of MPBio and Clinitest may consider extending their instructions for use to include combined oropharyngeal and nasal self-sampling, and other manufacturers of rapid antigen tests should consider evaluating this as well.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmj-2022-071215","type":"journal-article","created":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T20:05:13Z","timestamp":1663185913000},"page":"e071215","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":39,"title":["Diagnostic accuracy of covid-19 rapid antigen tests with unsupervised self-sampling in people with symptoms in the omicron period: cross sectional study"],"prefix":"10.1136","volume":"378","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9548-3214","authenticated-orcid":false,"given":"Ewoud","family":"Schuit","sequence":"first","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"},{"name":"Cochrane Netherlands, University Medical Centre Utrecht, Utrecht University, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1446-9614","authenticated-orcid":false,"given":"Roderick P","family":"Venekamp","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7950-2980","authenticated-orcid":false,"given":"Lotty","family":"Hooft","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"},{"name":"Cochrane Netherlands, University Medical Centre Utrecht, Utrecht University, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3132-4070","authenticated-orcid":false,"given":"Irene K","family":"Veldhuijzen","sequence":"additional","affiliation":[{"name":"Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0676-2594","authenticated-orcid":false,"given":"Wouter","family":"van den Bijllaardt","sequence":"additional","affiliation":[{"name":"Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, Netherlands"},{"name":"Department of Infection Control, Amphia Hospital, Breda, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1943-1217","authenticated-orcid":false,"given":"Suzan D","family":"Pas","sequence":"additional","affiliation":[{"name":"Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, Netherlands"},{"name":"Microvida Laboratory for Medical Microbiology, Bravis Hospital, Roosendaal, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0263-4379","authenticated-orcid":false,"given":"Vivian F","family":"Zwart","sequence":"additional","affiliation":[{"name":"Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther B","family":"Lodder","sequence":"additional","affiliation":[{"name":"Public Health Service West-Brabant, Breda, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7539-4233","authenticated-orcid":false,"given":"Marloes","family":"Hellwich","sequence":"additional","affiliation":[{"name":"Public Health Service Hart voor Brabant, Tilburg, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Koppelman","sequence":"additional","affiliation":[{"name":"National Screening laboratory of Sanquin, Sanquin Blood Supply foundation, Amsterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9004-3850","authenticated-orcid":false,"given":"Richard","family":"Molenkamp","sequence":"additional","affiliation":[{"name":"Department of Viroscience, Erasmus MC, Rotterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1845-1657","authenticated-orcid":false,"given":"Constantijn J H","family":"Wijers","sequence":"additional","affiliation":[{"name":"Public Health Service Rotterdam-Rijnmond, Rotterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene H","family":"Vroom","sequence":"additional","affiliation":[{"name":"Public Health Service Rotterdam-Rijnmond, Rotterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7631-8160","authenticated-orcid":false,"given":"Leonard C","family":"Smeets","sequence":"additional","affiliation":[{"name":"Reinier Haga Medical Diagnostic Centre, Delft, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carla R S","family":"Nagel-Imming","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0503-9783","authenticated-orcid":false,"given":"Wanda G H","family":"Han","sequence":"additional","affiliation":[{"name":"Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2968-9652","authenticated-orcid":false,"given":"Susan","family":"van den Hof","sequence":"additional","affiliation":[{"name":"Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2665-6844","authenticated-orcid":false,"given":"Jan A J W","family":"Kluytmans","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2728-4560","authenticated-orcid":false,"given":"Janneke H H M","family":"van de Wijgert","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2118-004X","authenticated-orcid":false,"given":"Karel G M","family":"Moons","sequence":"additional","affiliation":[{"name":"Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, 3584 CG Utrecht, Netherlands"},{"name":"Cochrane Netherlands, University Medical Centre Utrecht, Utrecht University, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,9,14]]},"reference":[{"key":"2025110102010556000_378.sep14_13.e071215.1","unstructured":"RIVM Centrum Infectieziektebestrijding. Status validatie SARS-CoV-2 antigeen sneltesten, 10 Mar 2021 [Dutch]. 2021."},{"key":"2025110102010556000_378.sep14_13.e071215.2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n1676"},{"key":"2025110102010556000_378.sep14_13.e071215.3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1003735"},{"key":"2025110102010556000_378.sep14_13.e071215.4","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.26.1.2002011"},{"key":"2025110102010556000_378.sep14_13.e071215.5","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-022-02300-9"},{"key":"2025110102010556000_378.sep14_13.e071215.6","unstructured":"European Centre for Disease Prevention and Control (ECDC). Considerations on the use of self-tests for COVID-19 in the EU\/EEA. https:\/\/www.ecdc.europa.eu\/sites\/default\/files\/documents\/Considerations-use-of-self-tests-for-COVID-19-in-the-EU-EEA-17-March2021-erratum.pdf; 2021."},{"key":"2025110102010556000_378.sep14_13.e071215.7","doi-asserted-by":"publisher","DOI":"10.1101\/2021.12.08.21267452"},{"key":"2025110102010556000_378.sep14_13.e071215.8","unstructured":"Molenkamp R, Igloi Z. Evaluation of Antigen rapid test and PCR test to Omicron variant. 2021."},{"key":"2025110102010556000_378.sep14_13.e071215.9","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.02479-21"},{"key":"2025110102010556000_378.sep14_13.e071215.10","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-022-00730-z"},{"key":"2025110102010556000_378.sep14_13.e071215.11","doi-asserted-by":"publisher","DOI":"10.1101\/2022.02.02.22270295"},{"key":"2025110102010556000_378.sep14_13.e071215.12","doi-asserted-by":"publisher","DOI":"10.1101\/2022.01.08.22268954"},{"key":"2025110102010556000_378.sep14_13.e071215.13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.h5527"},{"key":"2025110102010556000_378.sep14_13.e071215.14","unstructured":"European Centre for Disease Prevention and Control (ECDC). Combined indicator: 14-day notification rate, testing rate and test positivity, updated 16 September 2021, weeks 35-36 2021 [updated 16 September 2021]. https:\/\/www.ecdc.europa.eu\/en\/publications-data\/combined-indicator-week-36-2021."},{"key":"2025110102010556000_378.sep14_13.e071215.15","unstructured":"Rijksoverheid. Variants of the corona virus 2021 [updated 2 December 2021]. https:\/\/coronadashboard.rijksoverheid.nl\/landelijk\/varianten."},{"key":"2025110102010556000_378.sep14_13.e071215.16","unstructured":"Centrum Infectieziektebestrijding RIVM. Variants of the corona virus SARS-CoV-2 [Dutch] 2021 [updated 30 November 2021]. https:\/\/www.rivm.nl\/coronavirus-covid-19\/virus\/varianten."},{"key":"2025110102010556000_378.sep14_13.e071215.17","unstructured":"Centrum Infectieziektebestrijding RIVM. Epidemiologische situatie van SARS-CoV-2 in Nederland [Dutch] 2021 [updated 28 September 2021]. https:\/\/www.rivm.nl\/sites\/default\/files\/2021-09\/COVID-19_WebSite_rapport_wekelijks_20210928_1146_final.pdf."},{"key":"2025110102010556000_378.sep14_13.e071215.18","unstructured":"Team RCR . A language and environment for statistical computing. R Foundation for Statistical Computing, 2021."},{"key":"2025110102010556000_378.sep14_13.e071215.19","unstructured":"WHO. Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing WHO; 2022 9 Mar 2022."},{"key":"2025110102010556000_378.sep14_13.e071215.20","doi-asserted-by":"publisher","DOI":"10.1007\/s00430-021-00710-9"},{"key":"2025110102010556000_378.sep14_13.e071215.21","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.03961-2020"},{"key":"2025110102010556000_378.sep14_13.e071215.22","doi-asserted-by":"publisher","DOI":"10.1016\/j.jinf.2021.08.012"},{"key":"2025110102010556000_378.sep14_13.e071215.23","doi-asserted-by":"publisher","DOI":"10.3201\/eid2705.204688"},{"key":"2025110102010556000_378.sep14_13.e071215.24","doi-asserted-by":"publisher","DOI":"10.1038\/s41467-020-20568-4"}],"updated-by":[{"DOI":"10.1136\/bmj.o2241","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2022,9,16]],"date-time":"2022-09-16T00:00:00Z","timestamp":1663286400000}}],"container-title":["BMJ"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/data.bmj.org\/tdm\/10.1136\/bmj-2022-071215","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmj-2022-071215","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T09:01:20Z","timestamp":1761987680000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.bmj.com\/lookup\/doi\/10.1136\/bmj-2022-071215"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,14]]},"references-count":24,"alternative-id":["10.1136\/bmj-2022-071215"],"URL":"https:\/\/doi.org\/10.1136\/bmj-2022-071215","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2022.03.24.22272891","asserted-by":"object"},{"id-type":"doi","id":"10.1101\/2022.07.07.22277366","asserted-by":"object"}]},"ISSN":["1756-1833"],"issn-type":[{"value":"1756-1833","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,14]]}}}