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

NCT06963619 | Not Yet Recruiting

• 1 other identifier: DC-088045
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diagnostic Tests

Outcome Measures

Primary Outcomes (1)

• AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China

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

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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").

You may not qualify if:

• 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;

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-01