Not yet recruiting NCT06963619

AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Reference Interval Study Protocol - China

— Observational Diagnostic Tests

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Diagnostic Tests. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol

To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China [Time frame: 12 months]

Subjects who meet all the following criteria are eligible for inclusion:

Voluntarily participate in this study and sign informed consent;
Body Mass Index (BMI) ≥18.5 and <28kg/ m2;
Age ≥18 years old;
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").

Subjects who meet any of the following criteria will be excluded:

Physical examination, laboratory test/examination results meet any of the following:

eGFR(estimated glomerular filtration rate) (formula: CKD-EPI, chronic kidney disease epidemiology collaboration) < 60 mL/min/1.732
Systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mmHg
Glycated hemoglobin A1c (HbA1c) ≥ 6.0%; or fasting blood glucose ≥ 7.0 mmol/L
Total cholesterol ≥ 6.22 mmol/L and/or triglycerides ≥ 2.26 mmol/L
High-sensitivity troponin: Female: ≥15.6 pg/mL (ng/L), Male: ≥34.2 pg/mL (ng/L)
Electrocardiogram, with obvious abnormalities such as those that may cause cardiac structural changes or risk factors for arrhythmia as assessed by the investigator
Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
Subjects who withdraw informed consent;
Subjects assessed by the investigator as unsuitable for inclusion in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Center list to be confirmed — check the primary protocol.

NCT: NCT06963619 · DC-088045