Quidel has received CE Mark for TriageTrue high sensitivity troponin I test, the next-generation diagnostic assay for aid in diagnosis of myocardial infarction for use with the company's Triage MeterPro instrumented system.
Quidel said MI, or heart attack, occurs when some heart muscles don’t receive enough blood flow. The more the time passes without the treatment to restore the blood flow, the greater the damage to the heart muscle is caused.
World Health Organization (WHO) estimates that nearly 18 million people die each year from cardiovascular diseases (CVD) and 85% of all CVD deaths are due to heart attacks and strokes.
Troponin I, T and C are protein subunits that make up the troponin complex, which is integral in regulating myofibril contraction in skeletal and cardiac muscle cells. Cardiac troponin I assays are commonly used as aids in diagnosing MI which is injury to cardiac muscle cells caused by ischemia.
When an MI occurs, cardiac troponin I levels rise after the onset of cardiac symptoms. They reach peak at 12 to 16 hours and can remain elevated for 4 to 9 days.
Physicians determine the presence and concentration of troponin levels through serial monitoring at different time intervals to diagnose MI and differentiate it from other cardiovascular and non-cardiovascular conditions.
Quidel stated that latest troponin assays can detect and quantitate troponin at lower levels compared to previous generation assays. And this gives them higher sensitivity in detecting MI at the time of patient presentation.
Such advancement allows for time interval between baseline measurement and the second measurement of cardiac troponin to be shortened. It reduces the time to diagnosis and improve efficiency in the emergency department.
The TriageTrue high sensitivity troponin I test is a single-use fluorescence immunoassay device to be used with Quidel’s Triage MeterPro instrument. It is designed to determine the concentration of troponin I in whole blood or plasma specimens, anticoagulated with EDTA.
TriageTrue includes a redesigned cartridge that can improve assay sensitivity and precision which are important for the performance of high sensitivity troponin testing.
The assay uses monoclonal antibodies specific to human cardiac troponin I in detecting and quantiting cardiac troponin I.
Quidel president and CEO Douglas Bryant said: “We are very pleased to receive the CE Mark for our next-generation Troponin I assay. This accomplishment is truly a team effort, and really speaks to the success of our integration of our Triage team at Summers Ridge.
“We are proud to introduce the world’s first Near Patient high sensitivity diagnostic test for Troponin I, and are excited by the positive impact that we can make in accurately providing results in 20 minutes or less to aid in diagnosing a heart attack.”