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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diagnostic Tests

• Study Type: Observational
• Enrollment (Estimated): 240

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 21, 2025
• First Submitted That Met QC Criteria: May 6, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DC-088045

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No