[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587418":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":31,"sex":35,"minAge":36,"maxAge":20,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":20,"overallStatus":48,"whyStopped":20,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":20},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Experimental: Nasal sampling\u002FTesting (Self-Test)","EXPERIMENTAL","Each Participant will be provided a single-use test kit containing a BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, buffer and a sterile nasal swab. The Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, then interpret and record the result. The testing will be completed in a home like setting. After the anterior nasal swab is collected, the operator or delegated study staff will collect one anterior nasal swab from both nostrils of the subject for RT-PCR testing. VTM samples will be shipped daily to the central lab for testing with the RT-PCR protocols for Flu A, Flu B and SARS-CoV-2.\n\nThe order of collections will be based off the subject number.",[13],"Diagnostic Test: BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test","Diagnostic Test: BinaxNOW™ COVID-19\u002FFlu A\\&B Combo Self-Test\n\nThe BinaxNOW™ COVID-19\u002FFlu A\\&B Combo Self-Test is a visually read lateral flow in vitro immunoassay for the qualitative detection and differentiation of the nucleocapsid protein antigen to SARS-CoV-2, Influenza A, and Influenza B directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory infection.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Samantha Parsons, Manager of Clinical Operations","CONTACT","000-000-0000","samantha.parsons@abbott.com",{"type":28,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100587418","clinical-feasibility-of-the-binaxnow-covid-19flu-ab-combo-in-the-southern-hemisphere-100587418",false,"NCT06928129","Clinical Feasibility of the BinaxNOW™ COVID-19\u002FFlu A&B Combo in the Southern Hemisphere","Inclusion Criteria:\n\n* Participant is at least two (2) years of age, AND Participant is suspected of acute viral respiratory infection by a healthcare professional, AND\n* Participant is within five (5) days of symptom onset, AND\n\nParticipant is experiencing two or more of the following symptoms:\n\nFever of \\>100.0°F\u002F 37.8°C or chills, Cough, Fatigue, New loss of taste or smell, Congestion or runny nose, Shortness of breath or difficulty breathing, Sore throat, Muscle or body aches, Headache\n\n-The Participant and\u002For legally authorized representative is willing to undergo the informed consent\u002FAssent process prior to study participation. A minor will need the documented consent of their parent or legal guardian unless the site has an HREC waiver for parental consent for minors.\n\nExclusion Criteria:\n\n* Participant is currently enrolled in a study to evaluate an investigational drug or experimental treatment\n* Participants with an active nosebleed\n* Participant has undergone a nasal wash or nasal aspirate procedure on day of enrolment\n* Participant has tested positive for COVID-19 within the last 45 days\n* Participant has received a nasal vaccine (i.e. FluMist®) within the past 30 days.\n* Participant has received antiviral medications for Influenza (Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir) in the previous 45 days.\n* Participant has received medication or treatment for COVID-19 infection in the last 45 days (including antivirals (such as Paxlovid), convalescent plasma therapy, monoclonal antibody treatment (mAb), Remdesivir, long-acting antibody (LAAB) treatment (Evusheld)\n* Participant is unable to meet all inclusion criteria as listed above","ALL","2 Years",{"count":38,"type":39},700,"ESTIMATED","INTERVENTIONAL",[42],"NA","The study is designed as a clinical feasibility, to investigate the positive and negative percent agreement (PPA and NPA) of the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo against a highly sensitive PCR method(s) in symptomatic patients suspected of SARS-CoV-2 or influenza infection when nasal swabs are self-collected by the patient\u002Flay user.",[45,46,47],"Influenza Type A","Influenza Type B","COVID-19","NOT_YET_RECRUITING","2025-04-10",{"date":51,"type":52},"2025-04-15","ACTUAL",{"date":54,"type":39},"2025-06-30",{"date":56,"type":39},"2025-11-01",{"name":5,"class":6}]