{"id":"https://openalex.org/W4200186646","doi":"https://doi.org/10.1128/jcm.01884-21","title":"Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests","display_name":"Requirements and Study Designs for U.S. Regulatory Approval of Influenza Home Tests","publication_year":2021,"publication_date":"2021-12-16","ids":{"openalex":"https://openalex.org/W4200186646","doi":"https://doi.org/10.1128/jcm.01884-21","pmid":"https://pubmed.ncbi.nlm.nih.gov/34911365","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/9116184"},"language":"en","primary_location":{"id":"doi:10.1128/jcm.01884-21","doi":"https://doi.org/10.1128/jcm.01884-21","is_oa":false,"landing_page_url":"https://doi.org/10.1128/jcm.01884-21","pdf_url":null,"source":{"id":"https://openalex.org/S53087977","display_name":"Journal of Clinical Microbiology","issn_l":"0095-1137","issn":["0095-1137","1070-633X","1098-660X"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320263","host_organization_name":"American Society for Microbiology","host_organization_lineage":["https://openalex.org/P4310320263"],"host_organization_lineage_names":["American Society for Microbiology"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Microbiology","raw_type":"journal-article"},"volume":null,"type":"review","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/9116184","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5022293224","display_name":"Tony Yang","orcid":"https://orcid.org/0000-0002-0046-4492","observed_orcids":["https://orcid.org/0000-0002-0046-4492"]},"institutions":[{"id":"https://openalex.org/I201448701","display_name":"University of Washington","ror":"https://ror.org/00cvxb145","country_code":"US","type":"education","lineage":["https://openalex.org/I201448701"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Tony Yang","raw_affiliation_strings":["Biomedical Regulatory Affairs Program, University of Washington, Seattle, Washington, USA"],"raw_orcid":"https://orcid.org/0000-0002-0046-4492","affiliations":[{"raw_affiliation_string":"Biomedical Regulatory Affairs Program, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5073021330","display_name":"Larry G. Kessler","orcid":"https://orcid.org/0000-0002-8024-5424","observed_orcids":["https://orcid.org/0000-0002-8024-5424"]},"institutions":[{"id":"https://openalex.org/I201448701","display_name":"University of Washington","ror":"https://ror.org/00cvxb145","country_code":"US","type":"education","lineage":["https://openalex.org/I201448701"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Larry G. Kessler","raw_affiliation_strings":["Department of Pharmacy, University of Washington, Seattle, Washington, USA","School of Public Health, University of Washington, Seattle, Washington, USA"],"raw_orcid":"https://orcid.org/0000-0002-8024-5424","affiliations":[{"raw_affiliation_string":"Department of Pharmacy, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]},{"raw_affiliation_string":"School of Public Health, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045828406","display_name":"Matthew Thompson","orcid":"https://orcid.org/0000-0003-0256-8444","observed_orcids":["https://orcid.org/0000-0003-0256-8444"]},"institutions":[{"id":"https://openalex.org/I201448701","display_name":"University of Washington","ror":"https://ror.org/00cvxb145","country_code":"US","type":"education","lineage":["https://openalex.org/I201448701"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Matthew J. Thompson","raw_affiliation_strings":["Department of Family Medicine, University of Washington, Seattle, Washington, USA","Department of Global Health, University of Washington, Seattle, Washington, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Family Medicine, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]},{"raw_affiliation_string":"Department of Global Health, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5026718720","display_name":"Barry R. Lutz","orcid":"https://orcid.org/0000-0003-4298-4901","observed_orcids":["https://orcid.org/0000-0003-4298-4901"]},"institutions":[{"id":"https://openalex.org/I201448701","display_name":"University of Washington","ror":"https://ror.org/00cvxb145","country_code":"US","type":"education","lineage":["https://openalex.org/I201448701"]},{"id":"https://openalex.org/I4210135134","display_name":"Brotman Baty Institute","ror":"https://ror.org/03jxvbk42","country_code":"US","type":"facility","lineage":["https://openalex.org/I4210135134"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Barry R. Lutz","raw_affiliation_strings":["Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA","Department of Bioengineering, University of Washington, Seattle, Washington, USA"],"raw_orcid":"https://orcid.org/0000-0003-4298-4901","affiliations":[{"raw_affiliation_string":"Brotman Baty Institute for Precision Medicine, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701","https://openalex.org/I4210135134"]},{"raw_affiliation_string":"Department of Bioengineering, University of Washington, Seattle, Washington, USA","institution_ids":["https://openalex.org/I201448701"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5073021330"],"corresponding_institution_ids":["https://openalex.org/I201448701"],"apc_list":null,"apc_paid":null,"fwci":0.0765,"has_fulltext":false,"cited_by_count":3,"citation_normalized_percentile":{"value":0.1529485,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":94},"biblio":{"volume":"60","issue":"5","first_page":"e0188421","last_page":"e0188421"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10167","display_name":"Influenza Virus Research Studies","score":0.7675999999046326,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10167","display_name":"Influenza Virus Research Studies","score":0.7675999999046326,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.1492999941110611,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11754","display_name":"SARS-CoV-2 detection and testing","score":0.04259999841451645,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/point-of-care-testing","display_name":"point-of-care testing","score":0.7319999933242798},{"id":"https://openalex.org/keywords/regulatory-approval","display_name":"regulatory approval","score":0.6359999775886536},{"id":"https://openalex.org/keywords/fda-regulatory-pathways","display_name":"FDA regulatory pathways","score":0.6510000228881836},{"id":"https://openalex.org/keywords/emergency-use-authorization","display_name":"emergency use authorization","score":0.8669999837875366},{"id":"https://openalex.org/keywords/510-k-premarket-notification","display_name":"510(k) premarket notification","score":0.7919999957084656},{"id":"https://openalex.org/keywords/study-design","display_name":"research design","score":0.5770000219345093},{"id":"https://openalex.org/keywords/respiratory-viral-infections","display_name":"respiratory viral infections","score":0.7250000238418579},{"id":"https://openalex.org/keywords/home-testing","display_name":"home testing","score":0.30799999833106995}],"concepts":[{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.7318058609962463},{"id":"https://openalex.org/C108759981","wikidata":"https://www.wikidata.org/wiki/Q788590","display_name":"Authorization","level":2,"score":0.6344320774078369},{"id":"https://openalex.org/C89623803","wikidata":"https://www.wikidata.org/wiki/Q12184","display_name":"Pandemic","level":5,"score":0.6102659106254578},{"id":"https://openalex.org/C524204448","wikidata":"https://www.wikidata.org/wiki/Q788926","display_name":"Infectious disease (medical specialty)","level":3,"score":0.5653636455535889},{"id":"https://openalex.org/C3008058167","wikidata":"https://www.wikidata.org/wiki/Q84263196","display_name":"Coronavirus disease 2019 (COVID-19)","level":4,"score":0.5484446287155151},{"id":"https://openalex.org/C2777267654","wikidata":"https://www.wikidata.org/wiki/Q3519023","display_name":"Test (biology)","level":2,"score":0.5211098790168762},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.44739049673080444},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.41018372774124146},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.3709069490432739},{"id":"https://openalex.org/C2779134260","wikidata":"https://www.wikidata.org/wiki/Q12136","display_name":"Disease","level":2,"score":0.30046388506889343},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.19368889927864075},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.17428812384605408},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.1628817617893219},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.09582987427711487},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000086382","descriptor_name":"COVID-19","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":true},{"descriptor_ui":"D000086402","descriptor_name":"SARS-CoV-2","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007251","descriptor_name":"Influenza, Human","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":true},{"descriptor_ui":"D007753","descriptor_name":"Laboratories","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D058873","descriptor_name":"Pandemics","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1128/jcm.01884-21","doi":"https://doi.org/10.1128/jcm.01884-21","is_oa":false,"landing_page_url":"https://doi.org/10.1128/jcm.01884-21","pdf_url":null,"source":{"id":"https://openalex.org/S53087977","display_name":"Journal of Clinical Microbiology","issn_l":"0095-1137","issn":["0095-1137","1070-633X","1098-660X"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320263","host_organization_name":"American Society for Microbiology","host_organization_lineage":["https://openalex.org/P4310320263"],"host_organization_lineage_names":["American Society for Microbiology"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Microbiology","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:9116184","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/9116184","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Clin Microbiol","raw_type":"Text"},{"id":"pmid:34911365","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/34911365","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of clinical microbiology","raw_type":"Journal Article"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:9116184","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/9116184","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"J Clin Microbiol","raw_type":"Text"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9391000270843506,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F109429038","display_name":"Gates Ventures","ror":"https://ror.org/04kxtb734"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":22,"referenced_works":["https://openalex.org/W220935706","https://openalex.org/W1508868069","https://openalex.org/W1604348666","https://openalex.org/W2010622735","https://openalex.org/W2043307923","https://openalex.org/W2045859768","https://openalex.org/W2071772236","https://openalex.org/W2115104312","https://openalex.org/W2190078805","https://openalex.org/W2886385809","https://openalex.org/W2904354111","https://openalex.org/W2910953805","https://openalex.org/W2961988677","https://openalex.org/W2964533586","https://openalex.org/W2981119294","https://openalex.org/W2981767062","https://openalex.org/W3092428903","https://openalex.org/W3099522815","https://openalex.org/W3126304678","https://openalex.org/W3127064404","https://openalex.org/W3217515644","https://openalex.org/W4210396756"],"related_works":["https://openalex.org/W3171555212","https://openalex.org/W4205148896","https://openalex.org/W4415304583","https://openalex.org/W3109227465","https://openalex.org/W4392378567","https://openalex.org/W3023873487","https://openalex.org/W3118418695","https://openalex.org/W4210396756","https://openalex.org/W7161618598","https://openalex.org/W3018593530"],"abstract_inverted_index":{"Home":[0],"testing":[1,86],"for":[2,25,77,87,111,130,136],"infectious":[3,39],"disease":[4,40],"has":[5],"come":[6],"to":[7,53,121],"the":[8,11,34,61,69,82,97],"forefront":[9],"during":[10],"COVID-19":[12,78],"pandemic.":[13],"There":[14],"is":[15],"now":[16],"considerable":[17],"commercial":[18],"interest":[19],"in":[20],"developing":[21],"complete":[22],"home":[23,38,94,131],"tests":[24,133],"a":[26,90],"variety":[27],"of":[28,71,84],"viral":[29,138],"and":[30,43,48,64,108,116],"bacterial":[31],"pathogens.":[32],"However,":[33],"regulatory":[35,99],"science":[36],"around":[37],"test":[41,46],"approval":[42],"procedures":[44],"that":[45],"manufacturers":[47],"laboratory":[49],"professionals":[50],"will":[51],"need":[52],"follow":[54],"have":[55,127],"not":[56],"yet":[57],"been":[58],"formalized":[59],"by":[60,101],"U.S.":[62],"Food":[63],"Drug":[65],"Administration":[66],"(FDA),":[67],"with":[68,89],"exception":[70],"Emergency":[72],"Use":[73],"Authorization":[74],"(EUA)":[75],"guidance":[76,145],"tests.":[79],"We":[80],"describe":[81],"state":[83],"home-based":[85],"influenza":[88],"focus":[91],"on":[92],"sample-to-result":[93],"tests,":[95],"discuss":[96],"various":[98],"pathways":[100],"which":[102],"these":[103],"products":[104],"can":[105],"reach":[106],"populations,":[107],"provide":[109],"recommendations":[110,126],"study":[112],"designs,":[113],"patient":[114],"samples,":[115],"other":[117,137],"important":[118],"features":[119],"necessary":[120],"gain":[122],"market":[123],"access.":[124],"These":[125],"potential":[128],"application":[129],"use":[132],"being":[134],"developed":[135],"respiratory":[139],"infections,":[140],"such":[141],"as":[142,144],"COVID-19,":[143],"moves":[146],"from":[147],"EUA":[148],"designation":[149],"into":[150],"510(k)":[151],"requirements.":[152]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2021-12-31T00:00:00"}