Clinical Research Details Clinical Research Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol Study Description To validate a comparison of test results on intended use population samples on the IUO Access BNP Assay on DxI 9000 to the predicate assay in support of global regulatory submissions. Inclusion/Exclusion Criteria Inclusion Ability to provide informed consent Adult ≥ 22 years old, any gender, race, ethnicity Presenting with a clinical suspicion of new onset or worsening symptoms of heart failure. Ability to fulfill study data collection requirements (including NYHA evaluation questions) Exclusion Individuals < 22 years old Impairment in individual’s capacity to give informed consent Dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma). Stage 4 or 5 Chronic Kidney Disease (CKD) On chronic dialysis On nesiritide infusion Subject clinical / medical history access is not available to Sponsor, delegates, and FDA or other regulatory agencies upon request. Active participation in a clinical study that may interfere with participation in this study (e.g., investigational drug study) Reason(s) determined by the Principal Investigator that would place the individual at increased risk or preclude the individual from fully complying with or completing the study. Open Enrollment Contact Name: Morgan Manning-HensonContact Phone: (904) 244-4234Contact Email: morgan.henson@jax.ufl.edu Investigators Christine N. Gage, D.O. Emergency Medicine Phyllis L. Hendry, M.D., FAAP, FACEP Emergency Medicine