The US Food and Drug Administration (FDA) has approved clinical diagnostics company Beckman Coulter’s rapid heart failure assay, Access N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) assay.

Designed for the DxI 9000 Access Immunoassay Analyzer, the Access NT-proBNP assay can detect heart failure biomarkers in under 11 minutes.

It is a significant advancement for the rapid diagnosis of patients suspected of having acute heart failure, particularly in emergency department settings.

The assay also helps assess the severity and risk stratification of individuals with acute coronary syndrome.

This diagnostic tool measures concentrations of the N-terminal pro B-type natriuretic peptide in a patient's serum or plasma. Elevated levels of this peptide are indicative of heart failure.

Beckman said the assay adheres to the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, which recommend age-based cutoffs for heart failure diagnosis.

This ensures that patient results are evaluated within the context of clinically relevant parameters, including age, disease comorbidity data, and gender.

Beckman Coulter Chemistry, and Immunoassay general manager and senior vice-president Kathleen Orland said: “FDA clearance of the Access NT-proBNP assay is just the latest confirmation of the platform's capability to develop ever increasingly more sensitive and clinically relevant diagnostics.

“The combination of DxI 9000 Analyzer's expanding menu of assays and its operational excellence, highlighted by ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe is driving laboratory demand around the globe.” 

Factors such as gender, obesity, and kidney failure can influence natriuretic peptide levels. Beckman Coulter's assay accounts for these variables, providing clinicians with performance data that aids in the interpretation of patient samples and supports accurate diagnoses.