Chinese medical device manufacturer Mindray has rolled out high-sensitivity troponin I (hs-cTnI) and NT-proBNP cardiac biomarkers for the diagnosis and management of cardiovascular diseases (CVDs).
Mindray said that CVDs cause most of deaths worldwide, and early detection will play an important role in saving the lives of people with CVDs.
The company developed the cTnl and NT-proBNP, which enhance its portfolio of cardiac biomarkers, in collaboration with one of its subsidiaries, HyTest.
HyTest is engaged in manufacturing monoclonal antibodies and antigens that are primarily used as key components of laboratory tests.
The cTnl and NT-proBNP assays are recommended for patients suspected of Acute Coronary Syndrome (ACS) and heart failure in early screening, risk stratification, rapid diagnosis, and therapeutic monitoring.
Mindray developed the hs-cTnI assay for sensitivity, precision, and reliability in detecting myocardial injury, with a high detection rate and a low CV.
It meets the minimum requirements for hs-cTn by achieving a 93% detection rate between LoD and the 99th URL and an imprecision CV below 5% at the 99th URL.
Also, the 0-2h diagnostic algorithm study, conducted at the Hennepin Healthcare Research Institute, supports effectiveness of hs-cTn in diagnosing and managing cardiac conditions.
The NT-proBNP assay is an established cardiac marker, with high precision and strong anti-interference capacity, for heart failure and its management.
With a CV of ≤5% the assay shows high precision and minimises the interference from 55 common medications for heart diseases, enabling for heart failure detection and management.
The two assays, validated by Wuhan Asian Heart Hospital in China and Hennepin Healthcare Research Institute in the US, have shown superior clinical performance, said the medical device company.
Mindray IVD chief scientific officer Jianwen He said: “Through integrating HyTest’s pioneering antibodies and research on cardiac biomarkers with Mindray’s advanced reagent technology and platform, we will deliver more reliable solutions that bring improved patient outcomes in the field of cardiovascular diseases and beyond.”
