New study confirms clinical performance of Beckman Coulter's Access hsTnI Assay in expediting diagnosis of acute coronary syndrome

Dubai, UAE: A recent article in the Annals of Emergency Medicine reported on the diagnostic accuracy of the newly released Beckman Coulter Access high-sensitivity troponin (hsTnI) assay in expediting the emergency department (ED) disposition for patients evaluated for suspected acute coronary syndrome (ACS).1  The study confirmed the performance of Beckman Coulter’s new Access hsTnI assay when used together with clinical history and ECG results. The findings support the use of Access hsTnI in helping drive efficiency improvements in cardiac patient management enabling hospitals to develop fast-track protocols- that may result in early discharge for patients with suspected myocardial infarction.

The study suggests adding Access hsTnI to existing diagnostic pathways can improve resource use in chest-pain evaluations. This group of experts confirmed that using serial Access hsTnI results (at 0 and 2 hours)—in conjunction with using the new Vancouver Chest Pain and No Objective Testing pathways would enable one-third of patients to be safely discharged after a two-hour risk stratification with no further testing. They also found using Access hsTnI in the EDACS, m-ADAPT and HEART pathways can rapidly refer more than half of ED patients for objective testing.

The study validated Access hsTnI’s clinical performance in the existing two-hour diagnostic pathways for suspected ACS patients, using the Access hsTnI’s 99^th percentile upper reference limit from Beckman Coulter’s assay insert as the clinical cutoff value in accordance with international guidelines²,³. The Access hsTnI assay is available for use on the Access 2, DxI and the entire Beckman Coulter family of Access immunoassay systems and has received international clearances including 510(k) from the U.S. Food and Drug Administration (FDA) and CE Mark.

ACS has been a huge healthcare burden in many countries. It is estimated that more than 5.5 million people present to the emergency department each year with chest pain while only 13% have a final diagnosis of ACS. Patients with ACS in the Middle East⁴ are younger than in developed countries and have higher rates of diabetes and smoking. The overall hospital mortality is 3.6%.

“Beckman Coulter Diagnostics is committed to helping clinical partners focus on continuous improvement. The new, high-sensitivity assay provides much greater precision at very low levels of troponin, providing clinicians in the Middle East even greater confidence in interpreting test results over time periods as short as two hours from patients seeking emergency care due to chest pain. Doctors can make faster and more accurate decisions on whether a myocardial infarction has occurred, allowing more streamlined use of resources within the hospital This is an example of how accelerated diagnostic protocols can safely improve patient care. The Annals of Emergency Medicine study provides independent confirmation of the results obtained during our clinical trials of Access hsTnI," said Dr. Akram Azmy, Managing Director, Beckman Coulter Diagnostics, Middle East.

The Access hsTnI assay’s low-end sensitivity enables it to measure very low levels of cardiac troponin I (cTnI), and detect small differences in the cTnI level over time. In comparison to standard troponin assays, high-sensitivity assays demonstrate significantly improved precision at and below the 99^th percentile upper reference limit (URL), allowing better discrimination of small differences in troponin values between serial measurements.

More precise determination of the 99^th percentile URL has also led to an ability to report distinct reference ranges for men and women. Early detection of cTnl release helps physicians detect myocardial infarction earlier in the course of care.

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About Beckman Coulter

Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. With a rich 80-year history, Beckman Coulter is a strong partner for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.

References

• 
  Greenslade JH, et al. Diagnostic Accuracy of a New High-Sensitivity Troponin I Assay and Five Accelerated Diagnostic Pathways for Ruling Out Acute Myocardial Infarction and Acute Coronary Syndrome. Ann Emerg Med, April 2018; Vol 71, Issue 4, Pg. 439–451
• Roffi M, et al. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2015; 14;37(3):267–31.
• Thygesen K, et al. Third universal definition of myocardial infarction. Eur Heart J 2012; 33:2551–567.
• https://www.tandfonline.com/doi/pdf/10.2143/AC.64.4.2041607 

For more information, visit www.beckmancoulter.com.  
Emeel Bishay
Associate Director, Healthcare and Corporate Practice Lead
FleishmanHillard
+971-4450-2600
emeel.Bishay@fleishman.com 
Alexandra Awad
arketing Manager, Beckman Coulter
+971-4550-8780
aawad@beckman.com  

© Press Release 2018