myocardial infarction

The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.

The Access hsTnI assay was cleared for use on Beckman Coulter's Access 2, Dxl, and the entire Access family of immunoassay systems. It was CE marked in late 2017.

Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.

The Access hsTnI assay is to aid in diagnosing myocardial infarction in patients presenting with chest pains or other ischemic symptoms.

The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month. 

The scientists argued that studies indicate the creatine kinase-myocardial band testing has no "incremental value to patient care" and outlined steps to put the test to rest.

The agency cleared a handful of assays last month for the detection and diagnoses of toxoplasmosis, syphilis, sepsis, thyroid conditions, and other ailments. 

The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux. 

The test can measure lower levels of troponin, enabling doctors to more accurately identify patients who actually have an acute myocardial infarction.