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New Assay Detects Heart Failure Biomarker in Less than 11 Minutes

By LabMedica International staff writers
Posted on 30 May 2024
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Image: The Access NT-proBNP assay has received US FDA clearance on the DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)
Image: The Access NT-proBNP assay has received US FDA clearance on the DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 suffer from heart failure, which accounts for about 8.5% of all heart disease deaths in the United States. A new assay now aids in diagnosing individuals who are suspected of having acute heart failure in emergency departments, as well as in evaluating the severity and risk stratification of patients with heart failure and acute coronary syndrome.

The Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay from Beckman Coulter (Brea, CA, USA) measures the levels of N-terminal pro B-type natriuretic peptide in serum or plasma that is released in the heart. Elevated levels of these peptides may indicate heart failure. As per the latest heart failure guidelines issued by the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay includes age-based cutoffs to aid in the accurate diagnosis of heart failure, ensuring that results are interpreted within the correct clinical context for each patient.

The assay also accounts for other patient variables such as gender, obesity, and kidney failure, which can influence natriuretic peptide levels. The Access NT-proBNP assay provides clinical performance data for these specific patient groups to help clinicians interpret test results and make diagnoses more accurately. The U.S. Food and Drug Administration has now approved the Access NT-proBNP assay for assessing heart failure in less than 11 minutes using the Beckman Coulter DxI 9000 Immunoassay Analyzer.

"We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyzer," said Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter. "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."


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