Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
In a hospital setting, 1 in 20 patients had cardiac troponin levels above the cut off for diagnosing a heart attack, including patients with no clinical signs of one.
The high-sensitivity test runs on the Quidel Triage Meter Pro instrument and joins a growing list of similar tests that have recently received regulatory approvals.
In the study, the POC assay produced a result in 15 minutes with comparable performance to a high-sensitivity laboratory assay in ruling out AMI.
A high-sensitivity cardiac troponin T assay ruled out myocardial infarction in about 55 percent of patients within an hour, according to a new study.
The agency cleared two of the firm's high-sensitivity troponin I assays for use on the Atellica IM and Advia Centaur XP/XPT immunoassay analyzers.
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.