24th October, 2023
Mindray, a global leader in medical devices and solutions, introduces new high-sensitivity troponin I (hs-cTnI) and NT-proBNP cardiac biomarkers. The additions have enhanced Mindray's diverse portfolio of cardiac biomarkers for diagnosing and managing cardiovascular diseases (CVDs).
While CVDs are the leading cause of death worldwide, early detection is key in saving lives. Guidelines recommend the use of cTnl and NT-proBNP as essential biomarkers for suspected Acute Coronary Syndrome (ACS) and heart failure. They enable early screening, risk stratification, rapid diagnosis, and therapeutic monitoring, aiding timely life-saving clinical decisions.
Mindray's hs-cTnI and NT-proBNP assays are the outcome of a fruitful collaboration between Mindray and HyTest, a prominent global provider of antibodies and antigens acquired by Mindray in 2021. HyTest, renowned for their cardiac biomarker expertise, had their cardiac troponin complex material selected as the international troponin standard by AACC in 2004.
Validated by Wuhan Asian Heart Hospital in China and the Hennepin Healthcare Research Institute in the U.S., both assays showcase outstanding clinical performance.
Mindray's hs-cTnI assay far surpasses the minimum requirements for hs-cTn by achieving a remarkable 93% detection rate between LoD and 99th URL and an imprecision CV below 5% at the 99th URL. This demonstrates the assay's exceptional sensitivity, precision, and reliability in detecting myocardial injury. Furthermore, a 0-2h diagnostic algorithm study conducted at the Hennepin Healthcare Research Institute further supports its effectiveness in accurately diagnosing and managing cardiac conditions within this crucial timeframe.
NT-proBNP is an established cardiac marker for heart failure and its management. Mindray's NT-proBNP assay demonstrates high precision with a CV of ≤5% and effectively minimizes interference from 55 common medications for heart diseases, making it a reliable tool for heart failure detection and management.
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