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

NCT07208877 | Not Yet Recruiting

• 1 other identifier: DC-092723
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diagnostic Tests

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Eligibility Criteria

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

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: September 28, 2025
• First Posted: October 6, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09