Quidel receives CE mark for its TriageTrue high sensitivity troponin I test

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Quidel has received the CE mark for its TriageTrue high sensitivity troponin I test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction for use with Quidel’s Triage MeterPro instrumented system.

A press release reports that the TriageTrue high sensitivity troponin I test is a single-use fluorescence immunoassay device for use with Quidel’s Triage MeterPro instrument and designed to determine the concentration of troponin I in whole blood or plasma specimens, anticoagulated with EDTA. TriageTrue features a redesigned cartridge that greatly improves assay sensitivity and precision which are critical to the performance of high sensitivity troponin testing. The assay uses monoclonal antibodies specific to human cardiac troponin I in the detection and quantitation of cardiac troponin I. The results are displayed on the MeterPro screen in <20 minutes from the addition of specimen to the device. All results are stored in the MeterPro memory to display or print when needed. Also, the integrated cartridge design enables a lower total cost per reportable result than standard immunochemistry analysers in low volume settings. When connected, the MeterPro can transmit results to the laboratory or hospital information system. TriageTrue enables hsTnI testing to be performed in the emergency department, urgent care facilities and other decentralised settings.

Douglas Bryant, president and chief executive officer of Quidel Corporation, says: “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.”

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