Abbott wins CE mark for high sensitive troponin assay

10 January 2013 (Last Updated January 10th, 2013 18:30)

The European Union has granted CE mark approval to Abbott's chemiluminescent microparticle immunoassay (CMIA), designed to quickly evaluate potential heart attacks.

The European Union has granted CE mark approval to Abbott's chemiluminescent microparticle immunoassay (CMIA), designed to quickly evaluate potential heart attacks.

Developed for use on Abbott's fully-automated Architect family of analysers, the Architect Stat high sensitive Troponin-I assay quantitatively determines cardiac troponin I (cTnI) in human plasma and serum for the diagnosis of myocardial infarction (MI).

"The Architect Stat high sensitive Troponin-I assay quantitatively determines cardiac troponin I (cTnI) in human plasma and serum for the diagnosis of myocardial infarction (MI)."

In addition, cTnI values are used to assess 30-day and 90-day prognosis relative to all-cause mortality and major adverse cardiac events (MACE), including myocardial infarction, revascularisation, and cardiac death, in patients who present with symptoms suggestive of acute coronary syndrome (ACS).

The faster evaluation can allow doctors to reduce the time to diagnosis and treatment by several hours when compared to standard troponin tests, according to the company.

University Heart Centre cardiology director Professor Stefan Blankenberg said compared to current tests, the advantage of high sensitive troponin tests is that clinicians may now more precisely confirm or exclude a heart attack much sooner and with higher accuracy than with contemporary tests.

"This is important information for patient care because we can pursue treatment if needed or avoid invasive therapy and discharge a patient earlier," Blankenberg said.