Pharma Focus Asia

Mindray Expands Its Cardiac Biomarker Portfolio With State-of-the-art hs-cTnI and NT-proBNP Assays, Enhancing the Management of Cardiovascular Diseases

Tuesday, October 24, 2023

Mindray, a prominent global company specializing in medical devices and healthcare solutions, has introduced new cardiac biomarkers, including troponin I (hs-cTnI) and NT-proBNP, to enhance its diverse range of cardiac biomarkers designed for diagnosing and managing cardiovascular diseases (CVDs).

Given that CVDs are the leading cause of mortality worldwide, early detection is critical for saving lives. Medical guidelines recommend the use of cTnI and NT-proBNP as essential biomarkers for suspected cases of acute coronary syndrome (ACS) and heart failure, particularly in situations requiring early screening, risk assessment, swift diagnosis, and therapeutic monitoring.

These two diagnostic tests are the outcome of a collaboration between Mindray and HyTest, a subsidiary of Mindray that is a prominent global supplier of antibodies and antigens. HyTest is well-regarded for its expertise in the cardiac biomarker industry, and its Cardiac Troponin Complex was designated as an international troponin standard by the AACC in 2004.

These tests have been rigorously validated by the Wuhan Asian Cardiac Hospital in China and the Hennepin Healthcare Research Institute in the USA, demonstrating excellent clinical performance.

Mindray hs-cTnI Test: Precise Detection of Myocardial Injury with High Sensitivity and Low Variability

Mindray's hs-cTnI test surpasses the minimum requirements for high-sensitivity troponin, achieving an impressive 93% detection rate between the lower detection limit and the 99th upper reference limit. Additionally, it boasts an inaccuracy coefficient of variation (CV) below 5% at the 99th upper reference limit. These results highlight the test's outstanding sensitivity, accuracy, and reliability in identifying myocardial injury. Furthermore, a study of the 0-2 hour diagnostic algorithm, conducted at the Hennepin Healthcare Research Institute, has affirmed its effectiveness in diagnosing and managing heart disease during this critical early period.

Mindray NT-proBNP Test: High Precision and Robust Resistance to Interference

NT-proBNP is a widely recognized cardiac marker for heart failure and its management. Mindray's NT-proBNP test demonstrates high precision with a CV of ≤ 5% and effectively minimizes interference from 55 common medications used in heart disease, underscoring its reliability in detecting and managing heart failure.

Mindray IVD, stated, "Through the integration of Mindray's reagent platform and technology with HyTest's groundbreaking antibodies and cardiac biomarker research, we are poised to provide more dependable solutions that will lead to improved outcomes for patients with cardiovascular diseases and other medical conditions."



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