[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Abbott Rapid Dx\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":144},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,69,95,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100608563","dengue---sample-collection-study-pakistan-100608563",false,"NCT07203183","Dengue - Sample Collection Study Pakistan","A Prospective Study for the Collection of Whole Blood Samples to Support the Development and Validation of In Vitro Diagnostic Tests for Dengue","Inclusion Criteria:\n\n* Age ≥12-years-old\n* Individuals suspected or confirmed for active dengue, with dengue-consistent symptoms onset up to and including 10 days before enrolment in this trial.\n\nExclusion Criteria:\n\n* Subject has been vaccinated for dengue.\n* Subject participates in an investigative drug, vaccine or medical device clinical study\n* Participant is deemed unfit for the study by the Investigator\n* Participant is unwilling or unable to provide informed consent",true,"ALL","12 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The objective of this study is to collect well-characterized serum and plasma specimens from confirmed dengue positive and dengue negative subjects to support dengue diagnostic products development.",[25],"Dengue",[27,28,29,30,31],"dengue","sample collection","serum","plasma","blood","NOT_YET_RECRUITING","2025-09-24",{"date":35,"type":36},"2025-10-02","ACTUAL",{"date":38,"type":21},"2025-10-01",{"date":40,"type":21},"2026-04-01",{"name":42,"class":43},"Abbott Rapid Dx","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100587418","clinical-feasibility-of-the-binaxnow-covid-19flu-ab-combo-in-the-southern-hemisphere-100587418","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","2 Years",{"count":52,"type":21},700,"INTERVENTIONAL",[55],"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.",[58,59,60],"Influenza Type A","Influenza Type B","COVID-19","2025-04-10",{"date":63,"type":36},"2025-04-15",{"date":65,"type":21},"2025-06-30",{"date":67,"type":21},"2025-11-01",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":16,"sex":17,"minAge":75,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100553894","lay-user-evaluation-of-the-panbio-hcv-self-test-in-an-eu-population-100553894","NCT06492018","Lay User Evaluation of the Panbio™ HCV Self Test in an EU Population","Inclusion Criteria:\n\n* Participant is aged 18 or over\n* Participant agrees to all aspects of the study and is able and willing to provide informed consent \u002F assent with parental consent.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed unfit for the study by the Investigator.\n* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.\n* Participant is a practising health-care professional or laboratory scientist \u002F technician or has prior medical or laboratory training or experience\n* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.\n* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.\n* Participant is unwilling or unable to provide informed consent.","18 Years",{"count":77,"type":21},150,"This study is part of the performance evaluation to support the conformity assessment procedure for the use of fingerstick whole blood samples with Abbott's Panbio™ HCV Self Test device, as performed by lay users. The study will be conducted in accordance with the Commission Implementing Regulation (EU) 2022\u002F1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017\u002F746 of the European Parliament and of the Council and, to provide data to demonstrate the product is safe and effective for its intended use.",[80],"Hepatitis C",[82,83,84,85],"Rapid diagnostic test","Antibodies to Hepatitis C Virus (HCV).","Self-test","Lay user","2024-11-20",{"date":88,"type":36},"2024-11-22",{"date":90,"type":21},"2024-12-01",{"date":92,"type":21},"2025-03-30",{"name":42,"class":43},1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":16,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":53,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100562623","lay-user-evaluation-of-the-panbio-hcv-self-test-100562623","NCT06605573","Lay User Evaluation of the Panbio™ HCV Self-Test","Lay User Evaluation of the Panbio™ HCV Self Test: a Prospective, Multi-centre Observed Untrained User Study.","Inclusion Criteria:\n\n* Participant is aged 14 or over\n* Participant agrees to all aspects of the study and is able and willing to provide informed consent \u002F assent with parental consent.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is aware of their HCV status\n* Participant is deemed unfit for the study by the Investigator.\n* Participant has a condition deemed unfit by the Investigator to safely perform or receive the test.\n* Participant is a practising health-care professional or laboratory scientist \u002F technician or has prior medical or laboratory training or experience\n* Participant is currently enrolled in a study to evaluate an investigational drug or vaccine.\n* Participant has a visual impairment that cannot be restored using glasses or contact lenses or is unable to read the Instructions for Use.\n* Participant is unwilling or unable to provide informed consent.\n* Participant has participated in the study \"Lay user evaluation of the Panbio™ HCV Self Test: A prospective, multi-centre usability study to evaluate lay user labelling comprehension and test result interpretation\".","14 Years",{"count":104,"type":21},1185,[55],"This is a prospective, multi-centre study designed to evaluate the usability of the Panbio™ HCV Self Test, when performed by untrained lay users in an observed study setting. The Panbio™ HCV Self Test detects antibodies to Hepatitis C Virus (HCV). The study validation will be conducted in accordance with the World Health Organisation's technical guidance on Hepatitis C rapid diagnostic tests for professional use and\u002For self-testing (TSS-16).",[108],"HEPATITIS C (HCV)",[110,111,112,113,114],"diagnostics","rapid test","untrained user","hepatitis C","lateral flow test","2024-09-18",{"date":117,"type":36},"2024-09-20",{"date":119,"type":21},"2024-10",{"date":121,"type":21},"2025-03",{"name":42,"class":43},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":53,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":94},"100560981","evaluation-of-the-diagnostic-sensitivity-and-specificity-of-the-determine-syphilis-advanced-test-100560981","NCT06584214","Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","A Prospective, Multi-centre Study to Evaluate the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.","Inclusion Criteria:\n\n* 12 years of age or older.\n* The participant has confirmed previous \u002F current syphilis according to their medical history, or the participant has unknown or negative syphilis infection status.\n* The participant agrees to provide written informed consent.\n* The participant agrees to complete all aspects of the study.\n\nAdditional inclusion criteria for frozen samples:\n\n* The ethics committee-required written informed consent for study testing, or required documentation for sample use from a commercial vendor, is available.\n* Sufficient volume for testing is available and the sample quality is adequate (for example no significant sample hemolysis)\n* The sample must have been collected in EDTA vacutainers or serum tubes, processed to plasma and the plasma frozen within 36 hours of blood collection.\n\nExclusion Criteria:\n\n* Participant has already participated in this study on a previous occasion.\n* Participant is deemed vulnerable and \u002F or unfit for participation in the study by the Investigator.\n* Participant is unwilling or unable to provide informed consent.\n* Participant is currently enrolled in a study to evaluate an investigational new drug or vaccine.\n\nAdditional exclusion criteria for frozen samples\n\n* The sample has undergone more than one freeze thaw cycle\n* The sample has been kept at -20 °C (± 5 °C) longer than 12 months. If the sample has been kept longer than 12 months, the storage temperature must have been colder than -20 °C (± 5 °C).",{"count":131,"type":21},400,[55],"This is a prospective, multi-centre study which will evaluate the diagnostic sensitivity and specificity of the Determine™ Syphilis Advanced test. The test is intended for professional use and the performance evaluation will be performed by professional healthcare and laboratory staff. The study will also have a retrospective study arm. The Determine™ Syphilis Advanced validation will be conducted in accordance with the World Health Organization\\'s TSS-6 guidance on Syphilis rapid diagnostic tests, ISO 20916 (In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice), the study protocol, Good Clinical Practice and the respective local medical device laws.",[135],"Syphilis Infection","2024-09-02",{"date":138,"type":36},"2024-09-04",{"date":140,"type":21},"2024-09",{"date":142,"type":21},"2024-12",{"name":42,"class":43},""]