Comparison of NTproBNP2 Test Kit methods for diagnostic testing
AQT90 FLEX NTproBNP2 Test Kit Method Comparison Study
Radiometer Medical ApS · NCT06693050
This study is testing how well the NTproBNP2 Test Kit works with different types of blood samples to help diagnose heart issues in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radiometer Medical ApS (industry) |
| Locations | 3 sites (Badalona and 2 other locations) |
| Trial ID | NCT06693050 on ClinicalTrials.gov |
What this trial studies
This observational study aims to verify the performance claims of the NTproBNP2 Test Kit when used on the AQT90 FLEX analyzer, specifically comparing results obtained from whole blood and plasma samples. Participants will be adults aged 18 and older who can provide informed consent and have expected NT-proBNP concentrations within the assay's measuring range. The study will assess the accuracy and reliability of this diagnostic test in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates 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.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of heart failure diagnostics, leading to better patient management.
How similar studies have performed: Other studies have shown success in validating diagnostic tests, making this approach promising but not entirely novel.
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 assay. 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 * Subject, who has withdrawn consent.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
Badalona and 2 other locations
- Hospiltal Universitari Germans Trias i Pujol — Badalona, Spain (RECRUITING)
- Clinica Universidad de Navarra — Madrid, Spain (RECRUITING)
- Servicio Andaluz de Salud (SAS) - Hospital San Juan de la Cruz — Ùbeda, Spain (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Camilla Marvig
- Email: camilla.marvig@radiometer.dk
- Phone: +4528989671
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.
Conditions: Diagnostic Test