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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06963619

Enrollment

240

Registered

2025-05-09

Start date

2025-05-31

Completion date

2025-12-31

Last updated

2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Tests

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China	12 months	To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

Outcome results