AQT90 FLEX NTproBNP (N-terminal Pro-brain Natriuretic Peptide) 2 Test Kit - Clinical Evaluation Study Protocol - China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diagnostic Tests. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
NTproBNP2 Test Kit (Time-Resolved Immunofluorescence Method) Clinical Evaluation Study Protocol
Overview
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.
Primary outcome measures
- AQT90 FLEX NTproBNP2 Test Kit - Clinical Evaluation - China [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07208877 · DC-092723