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

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

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.