Study Shows Improved Patient Management and Outcome Using Abbott's Sensitive Troponin AssayBy Abbott, PRNE
Tuesday, May 17, 2011
Findings from recent JAMA study show increased detection of heart attacks
BERLIN, May 18, 2011 - 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
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
"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.
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
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
Media, Michelle Johnson, +1-847-935-0011 (office), or +1-847-736-6812 (mobile), or Darcy Ross, +1-847-937-3655 (office), or +1-224-475-7673 (mobile), or Financial, Angela Duff, +1-847-938-6894, all of Abbott
Tags: Abbott, Berlin, Germany, May 18