Diagnostic TestsNCT07208877
AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
An observational study of Diagnostic Tests, run by Radiometer Medical ApS.
Trial summary
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Tests
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Jan 2026
- 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: The study should select subjects that cover the intended population, considering differences in disease, age, and gender. It should not focus on a specific age group to ensure population representativeness. The samples (from the subject) contain interference also need to be involved.
Who may be able to join
- Samples that meet all the following criteria will be eligible for enrollment:
- Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure.
- Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..
- The sample volume is adequate, no less than 2 mL of whole blood.
- The sample collection shall meet the informed consent waiver requirements of the ethics committee.
Who cannot join
- Samples that meet any of the following criteria will be excluded:
- Duplicate collection of samples from the same subject.
- Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.
- Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
About this study
Official title: NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol
To validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
- 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 - Clinical Evaluation - China
Clinical evaluation indicator: The correlation coefficient between the investigational reagent and the predicate.
Evaluation criteria: The correlation coefficient between the investigational reagent and the predicate shall not be less than 0.95. The slope should be within the range of [0.9, 1.1]. If this requirement is not met, it is recommended to increase the sample size and provide a detailed rationale.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionJan 2026 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208877
- Sponsor's protocol ID
- DC-092723
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol
- ClinicalTrials.gov ID
- NCT07208877
- Acronym / sponsor ID
- DC-092723
- Conditions
- Diagnostic Tests
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Oct 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 validate the NTproBNP2 Test Kit by using the test results of the predicate device as a reference. It will be demonstrated that the investigational product (NTproBNP2 Test Kit) and the predicate are equivalent. Subsequently, it will be demonstrated that the investigational product can be used in clinical testing.
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
- The study should select subjects that cover the intended population, considering differences in disease, age, and gender. It should not focus on a specific age group to ensure population representativeness. The samples (from the subject) contain interference also need to be involved.
Key inclusion criteria (5 listed)
- Samples from subjects with current or previous signs and/or symptoms of heart failure, or diagnosed heart failure.
- Sample-related information is available, including a unique and traceable number, sample type, age, gender, date of sample collection, and clinical diagnosis, etc..
- The sample volume is adequate, no less than 2 mL of whole blood.
- The sample collection shall meet the informed consent waiver requirements of the ethics committee.
Key exclusion criteria (4 listed)
- Duplicate collection of samples from the same subject.
- Samples that do not meet the collection, handling, and storage requirements outlined in the product's instructions for use.
- Samples that are suspected of being poor quality, i.e. samples suspected of containing clots, visible hemolysis or lipids, or samples suspected of being contaminated with possible interfering substances.
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 - Clinical Evaluation - China
Time frame: 12 months
Clinical evaluation indicator: The correlation coefficient between the investigational reagent and the predicate. Evaluation criteria: The correlation coefficient between the investigational reagent and the predicate shall not be less than 0.95. The slope should be within the range of [0.9, 1.1]. If this requirement is not met, it is recommended to increase the sample size and provide a detailed rationale.
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 6 Oct 2025.
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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 4 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 6 Oct 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 - Clinical Evaluation - 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?
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 6 Oct 2025.