NEW YORK — QuidelOrtho said on Monday that it has received Canadian approval for a rapid point-of-care assay for myocardial infarction diagnosis.
The Quidel TriageTrue High-Sensitivity Troponin I test is a single-use fluorescence immunoassay that detects a subunit of the troponin complex released by heart muscle cells after a myocardial infarction. The test, which received CE marking in late 2018, uses whole blood or plasma specimens that have been anticoagulated with EDTA and runs on the Quidel Triage MeterPro analyzer. Results are provided within 20 minutes, according to San Diego-based QuidelOrtho.
QuidelOrtho was formed earlier this year through the $6 billion merger of Quidel and Ortho Clinical Diagnostics.