Getein Biotech hs-cTnI Successfully Achieves IFCC Certification

Recently, Getein Biotech chemiluminescence platform hs-cTnI received certification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), ensuring that its test results meet international standards of standardization and harmonization. This marks global recognition of the accuracy and compliance of Getein hs-cTnI testing technology. With standardized, compact, and efficient products, it helps medical institutions at all levels reduce the workload and improve the efficiency of cardiovascular disease testing.

Cardiac troponin (cTn) is currently recognized as the most specific cardiac biomarker and is found mainly in cardiomyocytes. When these cells are injured, cTn is rapidly released into the bloodstream. Because injury to other tissues or muscles rarely causes cTn elevation, cTn test results directly reflect cardiac injury and are among the most important biomarkers for diagnosing acute myocardial infarction (AMI). With the emergence of high-sensitivity cardiac troponin (hs-cTn) assays, detection sensitivity has improved substantially, enabling the identification of trace cardiac injuries that were previously difficult to detect. This allows earlier warning of cardiovascular disease risk and provides valuable time for early clinical intervention.

IFCC Standardization Certification

IFCC: The International Federation of Clinical Chemistry and Laboratory Medicine, founded in 1952, is one of the most influential international organizations in the fields of clinical chemistry and laboratory medicine. IFCC currently has members from 119 countries and regions. By collaborating with other international organizations to develop global standards, it continuously improves the accuracy, reliability, and comparability of laboratory testing.

IFCC C-CB: The IFCC Committee on Cardiac Biomarkers is one of IFCC's core professional committees. It focuses on the standardization, clinical application, and quality control of cardiac biomarkers. Its guidelines have become a core reference for laboratories and clinicians in managing cardiac biomarkers, and continue to lead technological innovation and standardized development in this field.

Getein Biotech chemiluminescence platform hs-cTnI has obtained NMPA certification and CE marking in 2022. Its successful inclusion in the IFCC Performance Reference Table further demonstrates that its excellent performance in analytical sensitivity and precision has reached internationally advanced levels. 

Getein Biotech hs-cTnI is one of its core products built on a self-developed magnetic-particle chemiluminescence technology platform. Leveraging high-affinity antibody pairs and an optimized signal amplification system, it benchmarks against international leading standards in key metrics such as limit of detection (LoD) and precision (%CV). It delivers excellent clinical performance and rapid turnaround, with a first-result time of only 12 minutes, meeting the turnaround-time (TAT) needs of emergency patients with chest pain. In addition, Getein chemiluminescence platform offers a comprehensive cardiovascular testing menu covering 11 cardiovascular biomarkers, including hs-cTnI, hs-cTnT, BNP, NT-proBNP, and ST2, providing clinicians with a powerful tool for diagnosing myocardial infarction, heart failure, and other cardiovascular diseases.

Since its founding, Getein has remained committed to its original aspiration of "pursuing excellence and delivering health," gaining deep insight into real clinical needs and focusing precisely on the testing pain points faced by medical institutions at all levels. Through technological innovation, it continuously enables the optimization of diagnostic and treatment workflows and cost control. The certified chemiluminescence testing platform uses differentiated, high-quality performance to precisely meet testing needs in different scenarios, achieving a seamless integration of standardized testing accuracy and a convenient diagnostic and treatment experience, and helping make high-quality medical resources more accessible.