Study Shows Improved Patient Management and Outcome Using Abbott's Sensitive Troponin Assay

BERLIN, May 18, 2011 /PRNewswire/ -- Research presented this week at the International Federation of Clinical Chemistry Congress and Laboratory Medicine showed that using a lower diagnostic threshold for troponin improves clinical outcomes and patient survival in patients with suspected acute coronary syndromes. Troponin is a protein found inside of heart cells that is released when they are damaged by ischemia or reduced blood supply.

Cardiac troponin is regarded by clinicians as one of the most specific biochemical markers for myocardial tissue injury, and the latest generation of more sensitive assays can identify patients with very small heart attacks. By improving the ability to accurately triage patients presenting with chest pain, the use of sensitive troponin assays could provide physicians with important information to help reduce patient deaths.

The diagnostic threshold used during the validation phase was 0.20 ng/mL. During the implementation phase, the diagnostic threshold was lowered to 0.05 ng/mL. The 2,092 patients with suspected ACS who presented at the Royal Infirmary of Edinburgh were stratified in three groups (troponin <0.05 ng/mL, 0.05 to 0.19 ng/mL, and greater than or equal to 0.20 ng/mL).

During the validation phase, 39 percent of patients with troponin concentrations of 0.05 to 0.19 ng/mL died or were readmitted with MI at one year. In contrast, only 21 percent of patients with troponin concentrations of 0.05 to 0.19 died or had a recurrent MI during the implementation phase. Lowering the diagnostic threshold resulted in more referrals to specialists and better treatment, explaining the improvement in clinical outcomes in these patients.

Nicolas Mills, M.D., Ph.D., a cardiologist at the British Heart Foundation Centre for Cardiovascular Science, and Simon Walker, M.D., Ph.D., a senior lecturer and consultant in the Department of Clinical Biochemistry at Edinburgh University, presented data from their study at a workshop sponsored by Abbott. The session, titled "The Importance of Biomarkers in Optimizing the Treatment of Patients with Heart and Kidney Disease," reviewed findings that were published in The Journal of the American Medical Association on March 23. The research shows using a lower diagnostic threshold can improve the early diagnosis of myocardial infarction (MI) by giving physicians important information to reduce the risk of death and admissions for recurrent myocardial infarction in high-risk patients. Mills and Walker used the ARCHITECT(R) STAT Troponin-I assay to explore the clinical benefits of lowering the diagnostic threshold for detecting cardiac troponin.

"In patients with suspected acute coronary syndrome, the more sensitive threshold for troponin testing increased detection of MI by 29 percent. It also identified patients at high risk for recurrent MI and death who would benefit from access to evidenced-based therapies for MI," said Mills. "As a result, the data shows more sensitive troponin assays can improve cardiac patient management by identifying important information for physicians, and, most importantly, save lives."

Abbott's fully automated troponin assay operates on the widely used ARCHITECT system, which enables laboratories to perform a broad menu of tests with optimal ease and efficiency. The ARCHITECT STAT Troponin-I assay is in available in some countries outside the U.S.

"Although more research is needed in this area, the findings are encouraging," said Sudarshan Hebbar, M.D., senior medical director, Diagnostics, Abbott. "When physicians have the necessary clinical and diagnostic information to detect heart attacks in patients who are at a greater risk for an event, they can administer the proper treatment sooner and improve treatment outcomes."

Intended Use and Important Safety Information for the ARCHITECT STAT Troponin assay. Available in some countries outside the U.S.:

For In Vitro Diagnostic Use

INTENDED USE: ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

IMPORTANT SAFETY INFORMATION: ARCHITECT STAT Troponin-I results should be used in conjunction with other information such as cardiac marker results (e.g., CK-MB and/or myoglobin), ECG, clinical observations and symptoms.

All ARCHITECT analyzers are Class I laser products. Refer to the Operations Manual for operational precautions, limitations and hazards.

For complete information, see the assay specific package insert and the ARCHITECT Operations Manual www.abbottdiagnostics.com.

About Abbott ARCHITECT

The ARCHITECT family delivers a complete portfolio of stand alone and integrated immunochemistry solutions. Since the introduction of the ARCHITECT i2000 more than a decade ago, Abbott has developed and launched a series of ARCHITECT analyzers that are delivering high quality results in a fully automated and integrated solution to conveniently meet the testing needs in today's clinical laboratory. With its extensive menu of more than 170 assays, ARCHITECT enables laboratories to meet increasing cost pressure, optimize throughput, and enhance overall productivity, while standardizing data management processes and optimizing inventory control.

The ARCHITECT family provides features that minimize training time and reduce inventory supply costs, while reducing sample contamination potential, which results in improved testing performance and outcomes for laboratories, physicians and patients.

About Abbott Diagnostics

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.