SARS-CoV-2 rapid antigen testing as a prognostic tool in COVID-19 outpatients: a multicenter, prospective cohort study

SARS-CoV-2 rapid antigen testing as a prognostic tool in COVID-19 outpatients: a multicenter, prospective cohort study | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 10 December 2025 V1 Latest version Share on SARS-CoV-2 rapid antigen testing as a prognostic tool in COVID-19 outpatients: a multicenter, prospective cohort study Authors : Kuang-Yu Niu , Chieh-Ching Yen , Yu-Chen Cheng , Chung-Hsien Chaou , Yu-Chi Tung , and Chi-Tai Fang 0000-0002-7380-1699 [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.176536450.09603750/v1 240 views 71 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Background Traditional COVID-19 prognostic models based on age, comorbidities, and vaccination status provide limited discriminative value in the era of widespread immunity. SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) rapidly identify individuals with high viral loads, but their prognostic utility remains uncertain. Materials and Methods In this multicenter prospective cohort study, 36,020 symptomatic outpatients underwent same-day Ag-RDT and RT-PCR testing between May and October 2021. Patients with RT-PCR–confirmed infection were followed for 14 days or until discharge. The primary outcome was respiratory failure or death; secondary outcomes included hospitalization and intensive care unit (ICU) admission. Results Thirty-six patients (0.1%) developed the primary outcome. A positive Ag-RDT result predicted the primary outcome with 80.6% sensitivity and 99.2% specificity, outperforming risk assessment based solely on age and comorbidities (69.4% and 99.7%, respectively). Positive Ag-RDT results were associated with higher viral loads (median cycle threshold, 19.5 vs. 30.9; P<0.001) and independently predicted the primary outcome (adjusted odds ratio [aOR], 2.90; 95% CI, 1.15–7.31), hospitalization (aOR 2.41), ICU admission (aOR 2.87), and in-hospital death (aOR 7.08). Conclusions SARS-CoV-2 Ag-RDT results provide rapid prognostic information that may guide antiviral therapy and follow-up intensity. Integrating Ag-RDT results into clinical workflows could improve contemporary COVID-19 outpatient management. Supplementary Material File (manuscript.docx) Download 254.89 KB Information & Authors Information Version history V1 Version 1 10 December 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords epidemiology public policy sars coronavirus social science virus classification Authors Affiliations Kuang-Yu Niu Linkou Chang Gung Memorial Hospital View all articles by this author Chieh-Ching Yen Linkou Chang Gung Memorial Hospital View all articles by this author Yu-Chen Cheng New Taipei City Municipal Tucheng Hospital View all articles by this author Chung-Hsien Chaou Linkou Chang Gung Memorial Hospital View all articles by this author Yu-Chi Tung National Taiwan University College of Public Health View all articles by this author Chi-Tai Fang 0000-0002-7380-1699 [email protected] National Taiwan University College of Public Health View all articles by this author Metrics & Citations Metrics Article Usage 240 views 71 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Kuang-Yu Niu, Chieh-Ching Yen, Yu-Chen Cheng, et al. SARS-CoV-2 rapid antigen testing as a prognostic tool in COVID-19 outpatients: a multicenter, prospective cohort study. Authorea . 10 December 2025. DOI: https://doi.org/10.22541/au.176536450.09603750/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! Copying failed. 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