Part 14 of IVD Hall of Fame
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The American Heart Association estimates that over 5 million Americans suffer from heart failure in the United States. B-type natriuretic peptide (BNP) assays measure the amount of BNP present in a blood sample of an individual with symptoms of congestive heart failure, such as shortness of breath. BNP is a naturally occurring hormone which is secreted from the heart when heart failure develops and worsens. In an emergency room, normal (non-elevated) BNP measurements can be used to rule out heart failure and elevated BNP measurements can help assess the severity of congestive heart failure.
The first BNP assay was Biosite Corporation’s Triage B-Type Natriuretic Peptide (BNP) Test which was cleared by FDA in 2000 following a de novo classification process. In 2003 and 2004, Bayer Diagnostics and Abbott Diagnostics respectively released automated, high-throughput testing options for the main clinical lab. Biosite Corporation received a CLIA waiver for their assay in 2005, indicated that the test could be used by non-laboratory personnel since it was simple and had a low risk for erroneous results.
Before the BNP assay was available, the standard of care for diagnosis of heart failure consisted of clinical evaluation, chest x-ray and (if available) echocardiography. BNP assays have changed patient care by providing a quick, easy test to help determine if a patient is in heart failure. Since symptoms of congestive heart failure, such as shortness of breath, are similar to other conditions, rapid diagnosis before the BNP assay could be difficult.
As a result of BNP testing, heart failure can be diagnosed earlier, resulting in earlier initiation of therapy. BNP testing also has the added benefit of reducing the number of unnecessary echocardiograms. Overall, BNP testing has improved the quality of life for patients congestive heart failure, and for those that should probably lay off the jalapeños.