[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567784":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":68,"collaborators":20,"id":70,"slug":20,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":20,"maxAge":20,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"DiaSorin Molecular LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Blinded, Prospective Arm","OTHER","Clinical specimens shall be collected prospectively from patients with signs or symptoms of respiratory tract infection. Nasal swab in Copan universal transport media (UTM) 3 milliliters for comparator testing should be collected by a healthcare professional.\n\nWhere subjects are willing and able, up to 40% of nasal swab for the investigational device will be self-collected under the guidance and supervision of a healthcare professional.\n\nNasopharyngeal (NPS) specimens (optional) should only be collected by a healthcare professional. All specimens collected from children 13 years or younger should only be collected by a trained healthcare professional. Follow the Centers for Disease Control and Prevention guidelines for collecting NPS swabs, unless otherwise specified by the sponsor.",[13],"Diagnostic Test: LIAISON NES FLU A\u002FB, RSV & COVID-19",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","LIAISON NES FLU A\u002FB, RSV & COVID-19","The LIAISON® NES FLU A\u002FB, RSV \\& COVID-19 assay used on the LIAISON® NES instrument is a real-time PCR system that enables the direct amplification, detection and differentiation of Flu A viral RNA, Flu B viral RNA RSV viral RNA, and SARS-CoV-2 RNA from dry nasal swabs. Nasal Swabs can be professionally collected by a Healthcare Provider or self-collected by the patient under the supervision of the healthcare provider. The collected nasal swab can then be directly loaded into the cartridge without nucleic acid extraction.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Janet Farhang","CONTACT","5124015472","janet.farhang@diasorin.com",[28,44,56],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"PAS Research - Henderson","RECRUITING","Henderson","Nevada","89014","United States",{"type":36,"coordinates":37},"Point",[38,39],-114.98194,36.0397,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":26},"Janet VP of Clinical Affairs",{"facility":45,"status":30,"city":46,"state":47,"zip":48,"country":34,"cosmosGeoPoint":49,"geoPoint":53,"contacts":54},"PAS Research - Pittsburgh","Pittsburgh","Pennsylvania","15227",{"type":36,"coordinates":50},[51,52],-79.99589,40.44062,{"lat":52,"lon":51},[55],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":26},{"facility":57,"status":30,"city":58,"state":59,"zip":60,"country":34,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"PAS Research - McAllen","McAllen","Texas","78504",{"type":36,"coordinates":62},[63,64],-98.23001,26.20341,{"lat":64,"lon":63},[67],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":69,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100567784",false,"NCT06672692","A Multi-Site Clinical Evaluation of the LIAISON NES FLU A\u002FB, RSV & COVID-19 Assay in Symptomatic Patients","NES ABCR","Inclusion Criteria:\n\n* The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).\n* The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.\n* The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection\n* Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.\n* The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL\n* The specimen was received in good condition (no leakage or drying of the specimen).\n\nExclusion Criteria:\n\n* Incorrect swab type\n* Incorrect transport media\n* Incorrect specimen handling (e.g. specimens not stored at recommended temperature)\n* The specimen has undergone more than two freeze\u002Fthaw cycles\n* Specimens collected with calcium alginate or organic swabs","ALL",{"count":78,"type":79},1000,"ESTIMATED","INTERVENTIONAL",[82],"NA","The DiaSorin Molecular LIAISON® NES FLU A\u002FB, RSV \\& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.\n\nThe LIAISON® NES FLU A\u002FB, RSV \\& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in a professional laboratory setting.\n\nNegative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.",[85,86,87,88],"Influenza a","Influenza B","RSV","COVID 19","2024-11-01",{"date":91,"type":92},"2024-11-04","ACTUAL",{"date":94,"type":92},"2024-09-30",{"date":96,"type":79},"2025-05",{"name":5,"class":6},3]