{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T11:53:01Z","timestamp":1785412381899,"version":"3.56.0"},"reference-count":22,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100020166","name":"Flu Lab","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020166","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,6,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Over-the-counter (OTC) lateral flow tests for respiratory viruses have newly emerged since the beginning of the coronavirus disease 2019 (COVID-19) pandemic and are increasingly available to consumers. While all marketed tests have met standards for Emergency Use Authorization (EUA),\n                      <jats:italic toggle=\"yes\">de novo<\/jats:italic>\n                      classification, or 510(k) clearance, limited data are available to inform consumers of their relative performance. We performed a head-to-head benchtop analytical assessment of OTC tests available for purchase from retailers in the United States in the fall of 2025. Contrived specimen dilution panels were prepared from propagated viral stocks of influenza A H1N1pdm09, influenza A H3N2, influenza B (Victoria lineage), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) JN.1 (Omicron variant) in clinical matrix and applied to the swab provided with each kit. Tests were subsequently performed according to the manufacturer\u2019s instructions for use, and results were interpreted by two readers blinded to the starting test material. Lower limits at which three of three replicates of test material were detected were within a fourfold dilution for all four viruses and all eight OTC tests evaluated. We found that at low viral concentrations, many OTC tests were interpreted as negative at the start of the stated interpretation window but converted to a positive result by the end of the interpretation window. We conclude that eight OTC tests that are currently readily available to consumers perform similarly in a contrived specimen analytical study, but we recommend that users of OTC lateral flow tests allow for the full incubation time before concluding that a test is truly negative.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>Our study provides consumers and medical professionals alike with a head-to-head comparison of the available over-the-counter coronavirus disease (COVID)\/flu rapid antigen tests through a controlled, systematic evaluation. We also highlight the observation that, at low viral concentrations, many of the tests converted from negative to positive during the designated \"interpretation window,\" resulting in a practical recommendation that consumers should wait for the full incubation time before concluding that a self-test is negative.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.00110-26","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T13:00:27Z","timestamp":1777554027000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Analytical comparison of over-the-counter multiplex tests for influenza A, influenza B, and SARS-CoV-2"],"prefix":"10.1128","volume":"14","author":[{"given":"Sarah","family":"Lohsen","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7904-4122","authenticated-orcid":false,"given":"Yana","family":"Hoy-Schulz","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annie","family":"Taing","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beth","family":"Coughlin","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordan","family":"Kim","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather B.","family":"Bowers","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pediatrics, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Sullivan","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pediatrics, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wilbur A.","family":"Lam","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pediatrics, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/01zkghx44","id-type":"ROR","asserted-by":"publisher"}],"name":"Wallace H. Coulter Department of Biomedical Engineering, Emory University School of Medicine and Georgia Institute of Technology","place":["Atlanta, USA"]},{"name":"Aflac Cancer and Blood Disorders Center of Children\u2019s Healthcare of Atlanta","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6600-0677","authenticated-orcid":true,"given":"Anuradha","family":"Rao","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pediatrics, Emory University School of Medicine","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah W.","family":"Satola","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2237-1713","authenticated-orcid":true,"given":"Gregory L.","family":"Damhorst","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Investigational Clinical Microbiology Core, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/02gars961","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine","place":["Atlanta, USA"]},{"id":[{"id":"https:\/\/ror.org\/03czfpz43","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for the Advancement of Diagnostics for a Just Society (ADJUST Center), Emory University","place":["Atlanta, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00312-23"},{"key":"e_1_3_3_3_2","unstructured":"NIH. 2025. The thin blue line - the history of the pregnancy test. Available from: https:\/\/history.nih.gov\/display\/history\/Pregnancy+Test+Timeline. Retrieved 18 Jan 2025."},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/infdis\/jiaf218"},{"key":"e_1_3_3_5_2","unstructured":"Jewett C Anthes E. 2025. First at-home combination test for flu and covid is OK\u2019d by the F.D.A. Available from: https:\/\/www.nytimes.com\/2023\/02\/24\/health\/covid-flu-test-fda.html?searchResultPosition=1. Retrieved 21 Oct 2023."},{"key":"e_1_3_3_6_2","unstructured":"USFDA. 2025. DEN240029. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfClia\/Results.cfm?start_search=1&Document_Number=DEN240029. Retrieved 18 Dec 2025."},{"key":"e_1_3_3_7_2","unstructured":"USFDA. 2025. K243262. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfClia\/Results.cfm?start_search=1&Document_Number=K243262&SortColumn=ded. Retrieved 13 Mar 2026."},{"key":"e_1_3_3_8_2","unstructured":"USFDA. 2026. K243256. Available from: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfClia\/Results.cfm?start_search=1&Document_Number=K243256&SortColumn=ded. Retrieved 13 Mar 2026."},{"key":"e_1_3_3_9_2","unstructured":"ACON. 2025. ACON laboratories announces breakthrough 4-in-1 flowflex plus RSV + Flu A\/B + COVID home test. Available from: https:\/\/flowflexcovid.com\/acon-laboratories-announces-breakthrough-4-in-1-flowflex-plus-rsv-flu-a-b-covid-home-test. Retrieved 7 Nov 2025."},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1039\/d5lc00305a"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.00548-25"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaf660"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.xpro.2024.103146"},{"key":"e_1_3_3_14_2","unstructured":"CDC. 2025. CDC\u2019s influenza SARS-CoV-2 multiplex assay. Available from: https:\/\/www.cdc.gov\/flu\/php\/laboratories\/influenza-sars-cov-2-multiplex-assay.html#cdc_generic_section_3-primers-and-probes-research-use-only. Retrieved 10 Mar 2026."},{"key":"e_1_3_3_15_2","unstructured":"UTHSC\/UCH. 2023. Accelerated emergency use authorization (EUA) summary UTHSC\/UCH SARS-COV-2 RT-PCR assay. Available from: https:\/\/www.fda.gov\/media\/137656\/download. Retrieved 12 Mar 2026."},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00711-18"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2009.06.005"},{"key":"e_1_3_3_18_2","unstructured":"USFDA. 2011. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of influenza viruses - guidance for industry and FDA staff. Available from: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/establishing-performance-characteristics-in-vitro-diagnostic-devices-detection-or-detection-and. Retrieved 28 Dec 2024."},{"key":"e_1_3_3_19_2","volume-title":"Diagnostic tools, gaps, and collaborative pathways in human H5N1 detection: rapid expert consultation","author":"National Academies of Sciences Engineering and Medicine","year":"2025","unstructured":"National Academies of Sciences Engineering and Medicine. 2025. Diagnostic tools, gaps, and collaborative pathways in human H5N1 detection: rapid expert consultation. The National Academies Press, Washington, DC."},{"key":"e_1_3_3_20_2","unstructured":"Flu Lab. 2025. Flu Lab. Available from: https:\/\/theflulab.org\/"},{"key":"e_1_3_3_21_2","unstructured":"CLSI. 2012. CLSI EP17 evaluation of detection capability for clinical laboratory measurement procedures. Available from: https:\/\/clsi.org\/shop\/standards\/ep17"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2025.25903"},{"key":"e_1_3_3_23_2","unstructured":"CDC. Weekly US influenza surveillance report: key updates for week 50 ending December 13 2025. Available from: https:\/\/www.cdc.gov\/fluview\/surveillance\/2025-week-50.html. Retrieved 29 Dec 2025."}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00110-26","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.00110-26","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T13:09:12Z","timestamp":1781701752000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.00110-26"}},"subtitle":[],"editor":[{"given":"Karen C.","family":"Carroll","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,6,2]]},"references-count":22,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6,2]]}},"alternative-id":["10.1128\/spectrum.00110-26"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.00110-26","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,2]]},"assertion":[{"value":"2026-01-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00110-26"}}