[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587418":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":33,"overallOfficials":17,"centralContacts":39,"locations":17,"responsibleParty":45,"collaborators":17,"id":47,"slug":17,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":17,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":17,"enrollmentInfo":54,"targetDuration":17,"studyType":57,"phases":58,"briefSummary":59,"conditions":60,"keywords":17,"overallStatus":64,"whyStopped":17,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":17},{"fullName":5,"class":6},"Abbott Rapid Dx","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Demonstrate the positive percent agreement (PPA) and negative percent agreement (NPA)","The primary objective of this study is to demonstrate 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. The patient\u002Flay user will perform the test, read, and interpret the test result.","5 months",[14],{"measure":15,"description":16,"timeFrame":12},"Demonstrate the accuracy of the BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test in patient\u002Flay user","The secondary objective of this study is to demonstrate the accuracy of the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo Self-Test in the hands of patients\u002Flay users, which are \"intended users\" in a point of care (POC) Clinical Laboratory Improvement Amendments of 1988 (CLIA) moderate, high or waived complexity test environment",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NA","SINGLE_GROUP","Study staff will collect two (2) anterior nasal swabs from each Participant.\n\nThe Participant will self-collect one (1) anterior nasal swab, perform the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, then interpret and record the result.\n\nSite staff will collect one (1) anterior nasal swab from the Participant by inserting the swab up to 1 inch into one of the anterior naris. Staff will rotate the swab against the nasal mucosa five (5) times to obtain sample and withdraw. Staff will repeat with the other anterior naris using the same swab, and vigorously elute the swab in Viral Transport Medium (VTM)\u002FUniversal Transport Media (UTM) immediately (within 5 minutes) of sample collection. The swab should be rotated vigorously in the VTM\u002FUTM liquid for 10 seconds. The swab head will be left in the VTM\u002FUTM, by snapping the shaft or clipping the base of the swab if necessary","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","Approximately 700 symptomatic participants will be enrolled to achieve at least 61 COVID PCR positive, 45 Flu A PCR positives, 30 Flu B PCR positives and 301 COVID and Influenza PCR negatives.\n\nThe total number of research-related anterior nasal swabs collected from each consented Participant is two (2). Participants ages two (2) years and older meeting eligibility criteria will be enrolled.\n\nThe order of nasal swab collection will be randomized according to the Participant ID as to which swab is used for BinaxNOW™ COVID-19\u002FFlu A\\&B Combo and which is to be eluted into VTM\u002FUTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing.\n\nFor Participants with an odd numbered Participant ID, the first swab will be self-collected and used for the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo. The second swab will be collected by a healthcare professional and eluted into VTM\u002FUTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The Participant will review the Instructions for Use, collect the nasal swab, and perform the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo, then interpret and record the result at the time specified in the product instructions.\n\nFor Participants with an even numbered Participant ID, the first swab will be collected by a healthcare professional and eluted into VTM\u002FUTM and will have the swab head left in the media (snap off or clip shaft) for comparator testing. The second swab will be self-collected and used for the BinaxNOW™ COVID-19\u002FFlu A\\&B Combo. Once the healthcare provider collected the swab for the comparator test the Participant will review the Instructions for Use.\n\nThe VTM\u002FUTM samples will be stored, handled, and tested with comparator assays according to the manufacturers' product instructions. VTM\u002FUTM specimens can be stored for up to 48 hours at 2-8°C. If delivery and processing of samples exceeds specified time periods, specimens should be transported in dry ice and once in laboratory frozen at -70°C or colder.\n\nEach Participant's demographic data, inclusion\u002Fexclusion data, days of symptom onset, comparator results, Education level, occupation, and socioeconomic status and other data points will be documented on the data collection worksheets and EDC.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"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.",[32],"Diagnostic Test: BinaxNOW™ COVID-19\u002FFlu A&B Combo Self-Test",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":17},"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.",[28],[40],{"name":41,"role":42,"phone":43,"phoneExt":17,"email":44},"Samantha Parsons, Manager of Clinical Operations","CONTACT","000-000-0000","samantha.parsons@abbott.com",{"type":46,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","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":55,"type":56},700,"ESTIMATED","INTERVENTIONAL",[19],"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.",[61,62,63],"Influenza Type A","Influenza Type B","COVID-19","NOT_YET_RECRUITING","2025-04-10",{"date":67,"type":68},"2025-04-15","ACTUAL",{"date":70,"type":56},"2025-06-30",{"date":72,"type":56},"2025-11-01",{"name":5,"class":6}]