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NCT Number: NCT07208877

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

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.

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Key information

Conditions

Diagnostic Tests

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Registry information

Official study title

NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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