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

Launched by RADIOMETER MEDICAL APS · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new test kit called the AQT90 FLEX NTproBNP2, which is used to measure a specific substance in the blood that helps doctors understand heart health. The goal is to establish a normal range for this test in healthy Chinese adults, which will help ensure that results are interpreted correctly in future patients. The trial is not yet recruiting participants, but when it starts, it will look for adults aged 18 and older with a body mass index (BMI) between 18.5 and 28.

To be eligible for the study, participants must be healthy and willing to sign a consent form. They should not have certain health issues, like high blood pressure, diabetes, or abnormal cholesterol levels. If someone joins the study, they will provide a small blood sample for testing. This study is important because it will help improve the understanding of heart health in the Chinese population, ultimately leading to better care for patients with heart-related conditions.

Gender

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Eligibility criteria

• Inclusion Criteria:
• Subjects who meet all the following criteria are eligible for inclusion:
• • 1. Voluntarily participate in this study and sign informed consent;
• • 2. Body Mass Index (BMI) ≥18.5 and \<28kg/ m2;
• • 3. Age ≥18 years old;
• • 4. 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").
• Exclusion Criteria:
• Subjects who meet any of the following criteria will be excluded:
• 1. 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
• • 2. Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
• • 3. Subjects who withdraw informed consent;
• • 4. Subjects assessed by the investigator as unsuitable for inclusion in this study.