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.
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.
