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Fabricating nanostructures on biosensors can enhance biomolecule orientation, minimize steric hindrance, and reduce non\u2010specific binding, resulting in improved signal\u2010to\u2010noise ratios and high sensitivity, making them promising point\u2010of\u2010care diagnostic. However, clinical translation remains limited by challenges in scalable and reproducible fabrication and insufficient diagnostic validation. Here, we introduce a nanowell biosensor (NW\u2010Biosen) fabricated via semiconductor manufacturing, enabling scalable production and yields &gt;1000 electrodes with reproducible properties. NW\u2010Biosen detects SARS\u2010CoV\u20102 antigens from patient nasal swabs within \u223c10 min, with high sensitivity and minimal interference from other coronavirus recombinant proteins, respiratory pathogens, bacteria, and environmental substances, while maintaining consistent reproducibility with different batches. We validated NW\u2010Biosen through two independent clinical trials involving 249 retrospective and 243 prospective patient samples. In prospective cohort, NW\u2010Biosen achieved 93.02% sensitivity, 98.73% specificity, and a Cohen's kappa of 0.927, indicating near\u2010perfect agreement with RT\u2010PCR and superior sensitivity compared to commercially available colorimetric kits. Thus, NW\u2010Biosen enables rapid, highly sensitive, reproducible, and cost\u2010effective at\u2010home detection, with real\u2010time data transmission to public health authorities via mobile app integrated with a miniature potentiostat.<\/jats:p>","DOI":"10.1002\/advs.202522897","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T10:55:05Z","timestamp":1773312905000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Mass\u2010Produced and High\u2010Performance Nanowell Biosensor Fabricated via Semiconductor Manufacturing for Rapid and Accurate COVID\u201019 Diagnosis in the Clinical Field"],"prefix":"10.1002","volume":"13","author":[{"given":"Yoo Min","family":"Park","sequence":"first","affiliation":[{"name":"Center for Nano\u2010Bio Development National NanoFab Center (NNFC)  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zahra","family":"Rezaei","sequence":"additional","affiliation":[{"name":"Division of Engineering in Medicine Brigham and Women's Hospital Department of Medicine Harvard Medical School  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nam Ho","family":"Bae","sequence":"additional","affiliation":[{"name":"Center for Nano\u2010Bio Development National NanoFab Center (NNFC)  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donggee","family":"Rho","sequence":"additional","affiliation":[{"name":"Center for Nano\u2010Bio Development National NanoFab Center (NNFC)  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Da\u2010Seul","family":"Kim","sequence":"additional","affiliation":[{"name":"Division of Engineering in Medicine Brigham and Women's Hospital Department of Medicine Harvard Medical School  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"EunYoung","family":"Go","sequence":"additional","affiliation":[{"name":"Mara Nanotech INC. Hanmir Hall Yongdang Campus Pukyong National University  Nam\u2010gu Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"YoungTae","family":"Seo","sequence":"additional","affiliation":[{"name":"Mara Nanotech New York INC.  New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seok Jae","family":"Lee","sequence":"additional","affiliation":[{"name":"Center for Nano\u2010Bio Development National NanoFab Center (NNFC)  Daejeon Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won Chan","family":"Seo","sequence":"additional","affiliation":[{"name":"Department of Materials System Engineering Pukyong National University  Nam\u2010gu Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luke P.","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Engineering in Medicine Brigham and Women's Hospital Department of Medicine Harvard Medical School  Cambridge MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"HeaYeon","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Engineering in Medicine Brigham and Women's Hospital Department of Medicine Harvard Medical School  Cambridge MA USA"},{"name":"Mara Nanotech INC. Hanmir Hall Yongdang Campus Pukyong National University  Nam\u2010gu Republic of Korea"},{"name":"Mara Nanotech New York INC.  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