Comparison of sample types and stability for a heart failure diagnostic test
AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study
This study is testing how different types of samples affect the accuracy of a heart failure diagnostic test for adults who have certain levels of a specific heart-related marker.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radiometer Medical ApS Industry-sponsored |
| Locations | 3 sites (Múrcia and 2 other locations) |
| Trial ID | NCT06905392 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the correlation between different sample matrices and assess the stability of samples for the NTproBNP2 Test Kit used on the AQT90 FLEX analyzer. Participants will be adults aged 18 and older who can provide informed consent and have expected NT-proBNP concentrations within the test's measuring range. The study will not involve any interventions but will focus on collecting and analyzing sample data to improve diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with expected NT-proBNP concentrations suitable for testing.
Not a fit: Patients who are pregnant, breastfeeding, or have previously participated in this study will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could enhance the reliability of heart failure diagnostics through improved sample handling and testing methods.
How similar studies have performed: While this study focuses on a specific diagnostic test, similar studies have shown that optimizing sample handling can significantly improve diagnostic accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study. * Subjects must be 18 years of age or older. * Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit. Exclusion Criteria: * Subjects known to be pregnant or breast-feeding. * Subjects previously enrolled in the study. * Subject, who has withdrawn consent.
Where this trial is running
Múrcia and 2 other locations
- Hospital Universitario Virgen de la Arrixaca — Múrcia, Spain (Active_not_recruiting)
- Hospital Clinico Universitario de Santiago Compostela — Santiago De Compostela, Spain (Recruiting)
- Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz — Ùbeda, Spain (Active_not_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.