Diagnostic TestsNCT06963619

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

An observational study of Diagnostic Tests, run by Radiometer Medical ApS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diagnostic Tests
How many people: 240 participants
Where: No sites listed yet
Study dates: May 2025to Dec 2025
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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

Who may be able to join

Subjects who meet all the following criteria are eligible for inclusion:
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").

Who cannot join

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

Show all 11Show fewer

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;
Subjects assessed by the investigator as unsuitable for inclusion in this study.

About this study

Official title: 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.

Conditions: Diagnostic Tests

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2025Dec 2025

First posted9 May 2025
Study startMay 2025 (estimated)
Primary completionAug 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diagnostic TestsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06963619
Sponsor's protocol ID: DC-088045
Status last verified: Jan 2025
First submitted: 21 Apr 2025
Last updated: 9 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Diagnostic Tests trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Reference Interval Establishment Study Protocol
ClinicalTrials.gov ID: NCT06963619
Acronym / sponsor ID: DC-088045
Conditions: Diagnostic Tests
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 240 participants (estimated)
Lead sponsor: Radiometer Medical ApSIndustry (pharma, biotech, devices)
Study start: May 2025 (estimated)
Primary completion: Aug 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 9 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: To establish the reference range of the NTproBNP2 Test Kit (time-resolved immunofluorescence method) in apparently healthy Chinese population.

Key inclusion criteria (5 listed)

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").

Key exclusion criteria (11 listed)

Physical examination, laboratory test/examination results meet any of the following:
Subjects who are unable to provide a sufficient volume (≈2 mL) of EDTAanticoagulated whole blood sample;
Subjects who withdraw informed consent;
Subjects assessed by the investigator as unsuitable for inclusion in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.

Related trials for Diagnostic Tests

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
RecruitingPhase 3
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
RecruitingPhase 2
Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MYELOMATCH Treatment Trial)
Core Binding Factor Acute Myeloid Leukemia
Active, not recruitingObservational study
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
Preeclampsia (PE)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Diagnostic Tests, run by Radiometer Medical ApS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AQT90 FLEX NTproBNP2 Test Kit - Reference Interval Establishment - China (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.