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High-sensitivity Troponin I IVD assay

The new high-sensitivity troponin I (TNIH) in vitro diagnostics assay is designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma. High-sensitivity troponin plays a critical role in the timely diagnosis of AMI, or heart attacks. The presence of cardiac troponin is specific to heart muscle death. The detection of circulating troponins has long been recognized as the gold standard for the diagnosis of AMI in patients who present with chest pain in the emergency room. Compared to traditional troponin assays, the Siemens Healthineers TNIH assay is able to detect lower levels of troponin and smaller changes to a patient’s troponin levels, which may be an early indication of AMI. This design affords clinicians greater confidence in patient results at the low end of the assay range by delivering precision that provides the ability to measure slight, yet critical, changes between serial troponin I values. Precision at the low end is important to minimize analytic variation that could confuse a clinician’s assessment of a clinically significant change. With this data in hand, clinicians have the ability to more quickly diagnose and treat patients with suspected AMI, in some cases in as little as one to three hours. The TNIH assay meets current European Society of Cardiology guideline recommendations. Further, clinical study data involving approximately 2,500 patients at different time points from more than 30 trial sites in the United States and Europe demonstrate the TNIH assay’s efficiency. The TNIH assay is available for use on the ADVIA Centaur XPT and ADVIA Centaur XP systems, the company’s high efficiency laboratory analysers. The company also plans to make the high-sensitivity troponin I assays available on its other testing systems, including the Dimension Vista, Dimension EXL and Atellica IM analyser.

Supplier: Siemens Healthineers

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