QuidelOrtho nabs Health Canada approval for high-sensitivity troponin I test on small-footprint analyzer

Heart Damage Social

QuidelOrtho on Monday announced that Health Canada has granted approval for the use of the Quidel TriageTrue High-Sensitivity Troponin I (hsTnl) test on the Quidel Triage MeterPro, a testing platform with a small-footprint analyzer, to aid in the diagnosis of myocardial infarction.

The hsTnl test provides a result within 20 minutes for quick decision-making that enables treatment, the firm said.

The test, a fluorescence immunoassay, runs on the Quidel Triage MeterPro platform and provides a quantitative determination of troponin I in ethylenediaminetetraacetic acid (EDTA) anticoagulated whole blood or plasma specimens as an aid in the diagnosis of myocardial infarction.

The assay's rapid turnaround may contribute to faster patient disposition, reduced length of stay, and increased emergency department throughput, QuidelOrtho said.

“Troponin is the body’s emergency alert system for heart attacks, but the earliest signals are extremely difficult to detect,” Douglas Bryant, president and CEO of QuidelOrtho, said in a statement. “Our new Quidel TriageTrue High-Sensitivity Troponin I Test enables clinicians to answer the heart’s call for help more quickly and determine the appropriate treatments with confidence. As the first high-sensitivity troponin assay on the smallest analyzer platform in Canada, our new assay can reduce the time to diagnosis, save lives, save worry, and save costs for both families and the healthcare system.”

In May, San Diego-based Quidel became QuidelOrtho after it completed the acquisition of Raritan, NJ-based Ortho Clinical Diagnostics.

In 2019, Ortho received the CE Mark for its Vitros high-sensitivity troponin I assay for detecting signs of heart attack.

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