Novel Assay Diagnoses Heart Failure

By HospiMedica International staff writers
Posted on 03 Feb 2025

Abbott’s Alere NT-proBNP assay for the Alinity i system has been granted US FDA clearance (Photo courtesy of Abbott)

Over 64 million people globally are affected by heart failure, which results in approximately one million emergency department visits annually in both the US and Europe. Heart failure can be challenging to diagnose due to its complex presentation and non-specific symptoms, such as dyspnea. Misdiagnosis can lead to increased morbidity, in-hospital mortality, and higher rates of re-admission. Hospitalization for heart failure is associated with poor outcomes, with up to 30% of patients passing away within a year. Additionally, hospitalization significantly contributes to healthcare costs. Therefore, accurate assessment of patients is crucial for resource optimization and improving clinical outcomes. A novel assay now provides a new tool to assist in heart failure diagnosis, delivering accurate results and enhancing lab efficiency.

Abbott (Chicago, IL, USA) has developed the Alere NT-proBNP assay to aid in diagnosing heart failure by measuring NT-proBNP levels, a key biomarker associated with cardiac stress. N-terminal pro b-type natriuretic peptide (NT-proBNP) is a protein involved in producing B-type natriuretic peptide (BNP), a hormone that the body produces when the heart is under extra strain to pump blood. In the emergency department, NT-proBNP measurements are used to diagnose heart failure in patients who are suspected of having new or worsening heart failure. The Alere NT-proBNP assay is a chemiluminescent microparticle immunoassay (CMIA) designed for the in vitro quantitative measurement of NT-proBNP in human serum and plasma, and is performed on the Alinity i system. This test provides precise and dependable results with minimal interference from biotin, an essential factor for accurate diagnosis and patient care, according to the company.

The Alere NT-proBNP assay for Alinity i is intended as a diagnostic aid for individuals suspected of having congestive heart failure and for detecting mild cardiac dysfunction. It also assists in determining the severity of heart failure in diagnosed patients and is used for risk stratification in those with acute coronary syndrome and congestive heart failure. Additionally, the assay can be used to monitor the treatment of patients with left ventricular dysfunction. The U.S. Food and Drug Administration (FDA) has approved Abbott's Alere NT-proBNP assay for Alinity i, offering a new diagnostic tool for heart failure.