Core Insights - The article highlights the significance of high-sensitivity cardiac troponin I (hs-cTnI) testing technology in the diagnosis of cardiac diseases, emphasizing the launch of a new hs-cTnI chemiluminescence reagent solution by Fipon Bio, which enhances precision in diagnostics for IVD manufacturers [1]. Group 1: hs-cTnI as the Gold Standard - Cardiac troponin I (cTnI) is a key structural protein in cardiac cells that is released into the bloodstream during myocardial injury, making it a core biomarker for diagnosing acute myocardial infarction (AMI) [2]. - hs-cTnI employs high-sensitivity detection technology, allowing for the accurate capture of extremely low concentrations of cTnI (pg/mL level), significantly improving the identification of minor or early myocardial damage [2]. - The definition of hs-cTnI includes a total imprecision (CV) of ≤10% at the 99th percentile and a detection rate exceeding 50% in healthy male and female populations, marking a breakthrough in accuracy and sensitivity compared to conventional cTnI testing [2]. Group 2: Clinical Value - Early diagnosis of acute myocardial infarction (AMI) is facilitated by hs-cTnI, which can detect elevated levels within 1-3 hours after the onset of symptoms, compared to traditional methods that typically require over 6 hours [3]. - hs-cTnI demonstrates high specificity for myocardial injury, effectively distinguishing AMI from other causes of chest pain, such as pulmonary embolism and myocarditis [3]. - In acute coronary syndrome (ACS), normal cTnI levels indicate a lower risk, allowing for reduced need for additional ECG tests, positioning hs-cTnI as a crucial risk stratification marker [4]. - The dynamic monitoring of hs-cTnI levels during cardiovascular disease treatment provides real-time insights into the extent of myocardial injury and recovery status, aiding in prognosis management [5]. Group 3: Fipon hs-cTnI Reagent Solution Advantages - Fipon's hs-cTnI solution boasts exceptional specificity and strong interference resistance, utilizing a combination of antibodies from different species to ensure accurate and timely AMI diagnosis [6]. - The solution achieves a high detection rate of over 95% in healthy populations, aligning with international high standards [7]. - The results from Fipon's hs-cTnI testing show a high correlation (R2 > 0.98) with those from leading international manufacturers, indicating reliability [8]. - The high sensitivity of the solution is characterized by a limit of quantification (LOQ) of less than 2 pg/mL, capturing extremely low concentrations of cTnI, and a high precision with total imprecision ≤5% [9]. Group 4: Fipon Bio's Chemiluminescence Reagent Solutions - Fipon Bio has developed approximately 80 chemiluminescence reagent solutions across core areas such as tumor markers, thyroid function, myocardial markers, infectious diseases, and inflammation, aimed at supporting IVD manufacturers in creating high-quality reagent products [11]. - The correlation for low-end detection results (less than 100 pg/mL) also reaches R > 0.96, showcasing excellent clinical diagnostic performance [12].