{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T10:43:54Z","timestamp":1763981034259,"version":"3.45.0"},"reference-count":25,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,11,15]],"date-time":"2025-11-15T00:00:00Z","timestamp":1763164800000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>In vitro diagnostics (IVDs) for severe acute respiratory syndrome coronavirus 2 (SARS\u2010CoV\u20102) played a critical role in the early detection and management of infection, yet regional disparities in their availability remain underexamined. We retrospectively analyzed molecular and antigen IVDs for SARS\u2010CoV\u20102 authorized by the U.S. Food and Drug Administration (FDA) and approved by the Pharmaceuticals and Medical Devices Agency (PMDA)\/Ministry of Health, Labour, and Welfare (MHLW) in Japan between 2020 and 2023, using publicly available data. The FDA granted Emergency Use Authorization (EUA) to 373 IVDs (302 molecular and 71 antigen), while the PMDA\/MHLW approved 153 IVDs (55 molecular and 98 antigen) under the Priority Review system within the regular approval framework. In the United States (US), authorizations surged in early 2020, whereas in Japan, approvals increased more gradually until mid\u20102021. Real\u2010time polymerase chain reaction and lateral flow immunoassay were the predominant methods for molecular and antigen tests, respectively, in both countries. In Japan, 71% of prescription\u2010only IVDs were developed by domestic companies, compared with 79% in the US. In summary, a greater number of IVDs for SARS\u2010CoV\u20102 were authorized in the US than were approved in Japan, particularly early in the pandemic. The EUA system in the US facilitated the rapid authorization of IVDs. Japan's Priority Review system enabled rapid approvals, while the newly introduced Emergency Approval system\u2014although not applied to IVDs for SARS\u2010CoV\u20102\u2014may enable more timely approval and distribution of IVDs in future public health emergencies.<\/jats:p>","DOI":"10.1111\/cts.70402","type":"journal-article","created":{"date-parts":[[2025,11,16]],"date-time":"2025-11-16T04:43:46Z","timestamp":1763268226000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["In Vitro Diagnostics for\n                    <scp>SARS<\/scp>\n                    \u2010\n                    <scp>CoV<\/scp>\n                    \u20102 Infection Authorized in the United States and Approved in Japan"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4568-9839","authenticated-orcid":false,"given":"Mayumi","family":"Idei","sequence":"first","affiliation":[{"name":"Medical Technology Innovation Center Juntendo University  Tokyo Japan"},{"name":"Department of Clinical Laboratory Medicine Juntendo University Graduate School of Medicine  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyoshi","family":"Asada","sequence":"additional","affiliation":[{"name":"Institute for Clinical and Translational Science Nara Medical University Hospital  Nara Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8082-8945","authenticated-orcid":false,"given":"Mototsugu","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Clinical and Translational Research Center Niigata University Medical and Dental Hospital  Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,15]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2001017"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30183-5"},{"volume-title":"Statement on the Fifteenth Meeting of the IHR (2005) Emergency Committee on the COVID\u201019 Pandemic","year":"2025","author":"World Health Organization","key":"e_1_2_9_4_1"},{"key":"e_1_2_9_5_1","unstructured":"World Health Organization \u201cRecommendations for National SARS\u2010CoV\u20102 Testing Strategies and Diagnostic Capacities: Interim Guidance \u201d(2021)."},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjgh-2018-001179"},{"key":"e_1_2_9_7_1","unstructured":"Centers for Disease Control and Prevention \u201cDiagnosis: Clinical Considerations for Care of Children and Adults With COVID\u201019 \u201d(CDC Website 2025) https:\/\/archive.cdc.gov\/#\/details?q=CDC%20guideline%20diagnosis%202019%20COVID&start=0&rows=10&url=https:\/\/www.cdc.gov\/coronavirus\/2019\u2010ncov\/hcp\/clinical\u2010care\/clinical\u2010considerations\u2010diagnosis.html."},{"key":"e_1_2_9_8_1","unstructured":"Editorial Committee for the Clinical Practice Guide \u201cClinical Management of Patients With COVID\u201019. Version 10.1. [in Japanese] \u201d(2024)."},{"key":"e_1_2_9_9_1","unstructured":"World Health Organization \u201cWHO COVID\u201019 Preparedness and Response Progress Report: 1 February to 30 June 2020 \u201d(WHO Website 2025) https:\/\/www.who.int\/publications\/m\/item\/who\u2010covid\u201019\u2010preparedness\u2010and\u2010response\u2010progress\u2010report\u2010\u2010\u20101\u2010february\u2010to\u201030\u2010june\u20102020."},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jgf2.512"},{"key":"e_1_2_9_11_1","unstructured":"T.Kageyama \u201cComprehensive Study on Testing Systems for Infectious Disease Crisis Management in Anticipation of the Post\u2010COVID\u201019 Era: 2021 Final Report of the MHLW Special Research Program on Health and Labour Sciences Research Grants [in Japanese]\u201d(MHLW Grants System Website 2025) https:\/\/mhlw\u2010grants.niph.go.jp\/project\/155946."},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2022.870738"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.3390\/diagnostics13091549"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-2667(24)00279-2"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(21)02346-1"},{"key":"e_1_2_9_16_1","first-page":"178","article-title":"Establishment and Activities of the Ad Hoc Committee on Novel Coronavirus: Roles of Laboratory Testing in Infection Control and Medical Care","volume":"69","author":"Yanagihara K.","year":"2021","journal-title":"JJSLM"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2310"},{"key":"e_1_2_9_18_1","unstructured":"Pharmaceutical Evaluation Division Pharmaceutical Safety and Environmental Health Bureau Ministry of Health Labour and Welfare \u201cApproval Scheme in the Emergency Approval System: Notification No. 0520\u20131 May 20 2022 [in Japanese]\u201d(2022)."},{"key":"e_1_2_9_19_1","unstructured":"Pharmaceutical Evaluation Division and Medical Device Evaluation Division Pharmaceutical Safety and Environmental Health Bureau Ministry of Health Labour and Welfare \u201cNotification on Handling of Priority Review Notification No. 0831\u20131 August 31 2020 [in Japanese]\u201d(2020)."},{"key":"e_1_2_9_20_1","unstructured":"Pharmaceutical Evaluation Division and Medical Device Evaluation Division Pharmaceutical Safety and Environmental Health Bureau Ministry of Health Labour and Welfare \u201cHandling on Regulatory Reviews of Drugs Medical Devices IVDs and Regenerative Medical Products for the Time Being Associated With COVID\u201019: Office Memorandum April 13 2020 [in Japanese]\u201d(2020)."},{"key":"e_1_2_9_21_1","first-page":"37","article-title":"PMDA'S Response to Emergency Diagnosis, Treatment Methods, and Vaccine Regulations","volume":"32","author":"Sato D.","year":"2022","journal-title":"Journal of Health and Society"},{"key":"e_1_2_9_22_1","unstructured":"US Food and Drug Administration \u201cEmergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders \u201d(2017)."},{"key":"e_1_2_9_23_1","unstructured":"US Food and Drug Administration \u201cIn Vitro Diagnostics EUAs \u201d(FDA Website 2025) https:\/\/www.fda.gov\/medical\u2010devices\/covid\u201019\u2010emergency\u2010use\u2010authorizations\u2010medical\u2010devices\/in\u2010vitro\u2010diagnostics\u2010euas."},{"volume-title":"COVID\u201019: FDA Took Steps to Help Make Tests Available; 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