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

NCT ID: NCT06963619

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2025-12-31

Brief Summary

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

Conditions

Diagnostic Tests

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiometer Medical ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DC-088045

Identifier Type: -

Identifier Source: org_study_id