Diagnostic testing solutions provider Quidel has received a CE Mark for its diagnostic assay TriageTrue High Sensitivity Troponin I Test for determining troponin I in EDTA anticoagulated whole blood and plasma specimens.
The single-use fluorescence immunoassay device will be used as an aid to diagnose myocardial infarction (MI), or heart attack, for use with the company’s Triage MeterPro instrumented system.
This will be helpful to determine the concentration of troponin I in whole blood or plasma specimens, anticoagulated with EDTA.
MI occurs when a part of the heart muscle fails to receive enough blood flow.
Quidel president and CEO Douglas Bryant said: “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.”
According to Quidel, the new troponin assays are capable of detecting and quantitating troponin at lower levels.
TriageTrue features a redesigned cartridge that is said to improve sensitivity and precision of the assay.
The MeterPro screen displays the results in less than 20 minutes from the addition of specimen to the device.
All results are stored in the MeterPro memory to display or print based on requirement.
The device enables performing of hsTnI testing in the emergency department, urgent care facilities and other decentralised settings.
Quidel’s products are marketed under the Sofia, QuickVue, D3 Direct Detection, Thyretain, Triage and InflammaDry brand names.