Kidney disease is a growing global concern, affecting approximately 850 million people worldwide. In China, chronic kidney disease has reached a prevalence rate of 8.2%, impacting one in every ten people. This makes kidney health a critical issue, underscoring the importance of reliable diagnostic methods. Creatinine levels, a byproduct of muscle metabolism, are one of the most essential biomarkers for assessing kidney function. Elevated creatinine levels often signal impaired kidney function, making accurate and efficient testing methods vital for early detection and management.
The Need for Improved Creatinine Testing Methods
Traditionally, clinical creatinine testing relied on the Jaffe reaction, also known as the alkaline picrate method. While this method has been widely used, it is prone to interference from other substances, leading to inaccurate results. In contrast, enzymatic creatinine testing, which involves methods such as creatinine amidohydrolase and creatinine oxidase, offers superior specificity, accuracy, and resistance to interference. Among these, the creatinine oxidase method stands out, providing a broader linear range and enhanced reliability, particularly in clinical settings where sample quality can vary.
However, despite the advances in enzymatic methods, challenges such as reagent stability, interference from substances like calcium dobesilate, and the complexity of multi-enzyme systems remain. This is where HZYMES steps in with a groundbreaking approach to creatinine testing.
HZYMES’ Innovations in Creatinine Testing
HZYMES has taken the enzymatic testing method a step further, introducing key innovations that significantly enhance the performance of creatinine test kits. The company has focused on improving the stability and accuracy of the core enzymes involved in the testing process. Two key enzymes—creatinase and catalase—play pivotal roles in ensuring reliable and consistent results.
Creatinase and Catalase Upgrades
Creatinase, a crucial enzyme in the creatinine detection system, hydrolyzes creatinine into intermediate compounds for further analysis. HZYMES has optimized this enzyme through enzyme-directed evolution, resulting in the 13M4 creatinase mutant, which demonstrates enhanced thermal stability and enzyme activity. This innovation has led to a substantial increase in the enzyme’s half-life and performance, ensuring stable reagent functionality even under challenging conditions.
Another important enzyme, catalase, is added to eliminate interference from endogenous creatine, which can skew test results. HZYMES has made significant strides in optimizing catalase's structure and purification process, achieving a remarkable 20-fold increase in its half-life at elevated temperatures. This upgrade ensures that the reagents maintain their performance over extended periods, even after prolonged exposure to high temperatures.