[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diagnostic-tests\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diagnostic-tests":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100609001","aqt90-flex-ntprobnp-n-terminal-pro-brain-natriuretic-peptide-2-test-kit---clinical-evaluation-study-protocol---china-100609001",false,"NCT07208877","AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China","NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol","Inclusion Criteria:\n\nSamples that meet all the following criteria will be eligible for enrollment:\n\n1. Samples from subjects with current or previous signs and\u002For symptoms of heart failure, or diagnosed heart failure.\n2. Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..\n3. The sample volume is adequate, no less than 2 mL of whole blood.\n4. The sample collection shall meet the informed consent waiver requirements of the ethics committee.\n\nExclusion Criteria:\n\nSamples that meet any of the following criteria will be excluded:\n\n1. Duplicate collection of samples from the same subject.\n2. Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.\n3. Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","OBSERVATIONAL","To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.",[24],"Diagnostic Tests","NOT_YET_RECRUITING","2025-09-28",{"date":28,"type":29},"2025-10-06","ACTUAL",{"date":31,"type":20},"2025-10",{"date":33,"type":20},"2026-01",{"name":35,"class":36},"Radiometer Medical ApS","INDUSTRY",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":46,"conditions":47,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":4},"100590146","aqt90-flex-ntprobnp-n-terminal-pro-brain-natriuretic-peptide-2-test-kit---reference-interval-study-protocol---china-100590146","NCT06963619","AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China","NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol","Inclusion Criteria:\n\nSubjects who meet all the following criteria are eligible for inclusion:\n\n1. Voluntarily participate in this study and sign informed consent;\n2. Body Mass Index (BMI) ≥18.5 and \\\u003C28kg\u002F m2;\n3. Age ≥18 years old;\n4. Through the investigator's consultation with the subjects, evaluate the subjects who meet the requirements of the reference individual of this study (refer to the \"reference individual questionnaire\").\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded:\n\n1. Physical examination, laboratory test\u002Fexamination results meet any of the following:\n\n   * eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) \\\u003C 60 mL\u002Fmin\u002F1.732\n   * Systolic blood pressure ≥130 mm Hg and\u002For diastolic blood pressure ≥80 mmHg\n   * Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol\u002FL\n   * Total cholesterol ≥ 6.22 mmol\u002FL and\u002For triglycerides ≥ 2.26 mmol\u002FL\n   * High-sensitivity troponin: Female: ≥15.6 pg\u002FmL (ng\u002FL), Male: ≥34.2 pg\u002FmL (ng\u002FL)\n   * Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator\n2. Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;\n3. Subjects who withdraw informed consent;\n4. Subjects assessed by the investigator as unsuitable for inclusion in this study.",{"count":45,"type":20},240,"To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.",[24],"2025-05-06",{"date":50,"type":29},"2025-05-09",{"date":52,"type":20},"2025-05",{"date":54,"type":20},"2025-12",{"name":35,"class":36}]