Abbott has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its i-STAT BNP cartridge, a new point of care diagnostic test used to quickly assess the level of BNP (brain naturietic peptide) in patients in emergency rooms, heart failure clinics and observation units, laboratories and other critical care settings.
BNP is a protein secreted into the bloodstream by heart tissue during congestive heart failure (CHF), a disease in which the heart loses its ability to adequately pump blood throughout the body, and which results in a build-up of fluid pressure inside the heart, an Abbott release said.
CHF is often challenging to diagnose because its key signs and symptoms - such as shortness of breath and fatigue - are relatively non-specific and often associated with other conditions. Determining the level of BNP in a patient's blood, an objective marker of the presence of heart failure, can help physicians quickly and more accurately diagnose and assess disease severity. Additionally, BNP testing at the patient bedside accelerates triage, diagnosis, treatment and disposition of patients, clearing overcrowded emergency departments.
The BNP cartridge is designed for use with the i-STAT System, a market-leading automated hand-held blood analyzer that performs a comprehensive panel of critical tests at the patient's bedside in only a few minutes, producing lab-quality results that allow health care professionals to make rapid diagnosis and treatment decisions for their patients.
"Nearly 80 per cent of heart failure patients admitted to the hospital come through the emergency department," said Thomas Bugliosi, M.D., medical director, Abbott Point of Care. "These patients present with shortness of breath, which doctors must assess to differentiate between heart attack, pulmonary embolism, asthma, the flu or a number of other conditions in addition to CHF. Point of care testing for BNP is an important advance for patients and physicians, who can make differential diagnosis and informed decisions on patient care more quickly and accurately."
The new i-STAT BNP cartridge is a single-use, in vitro diagnostic test intended for use by license practitioners to measure the level of BNP with just a drop of blood, delivering lab-accurate results in approximately 10 minutes at the patient's bedside. (Current clinical guidelines state that turnaround time for BNP results should be less than 60 minutes). Research has shown that early diagnosis and treatment of heart failure with intravenous drug therapy in the emergency department reduced length of stay by 35 per cent and mortality for admitted patients by 60 per cent.