B-041 Development of 900 tests/h Electrolyte Analyzer which has high accuracy and precision

Abstract Background In clinical laboratories, the analysis of electrolytes such as sodium, potassium, and chloride are widely used as the clinical tests. The efficiency and accuracy of electrolyte analysis are critical for rapid diagnosis and medical treatments. However, the conventional Electrolyte Analyzer often faces the limitations in analysis speed, which delays the medical results and impact patient care. Moreover, reducing the amounts of waste is also an important theme from the perspective of the SDGs. To solve these problems, we have developed a new Electrolyte Analyzer that can analyze 1.5 times faster and reduces the amount of medical waste to 43% rather than the conventional one, keeps high accuracy and precision simultaneously. Methods Our conventional Electrolyte Analyzer can analyze sodium, potassium, and chloride concentrations of serum, plasma, and urine samples. Since the samples have a wide range of electrolyte concentrations and interference substances, it requires a process to wash the electrode and flow path after measuring a sample. However, insufficient washing may result in residual sample in the electrode or flow path, affect the accuracy and precision of the next sample analysis. And washing processes cause to increase the time required to analyze a sample, which limits an improvement of analysis time. To solve this problem, we changed an analysis sequence to measure the base solution as a reference and wash the electrode and flow path simultaneously to shorten the analysis time. This change reduces the steps from two (measuring the base solution and washing) to one. In addition, our new Electrolyte Analyzer analyze samples by diluting them with reagents, reducing the effects of interferences, shorten time for supplying the reagents without increasing the effect of interferences. Results By changing the analysis sequence and reducing the amounts of reagents, time to analyze a serum sample was shortened from 18 seconds to 12 seconds. We have succeeded in achieving 900 tests/h, which is 1.5 times faster than the conventional Electrolyte Analyzer. Also, it uses less amounts of reagents low as 43% compared to the conventional one. Minimizing wastes, contributing to a more sustainable and environmentally friendly operation. It uses highly durable crown ether membrane (Na, K) and quaternary ammonium salty membrane (Cl) ion selective electrodes. By using these electrodes, it also maintains high accuracy and precision with a coefficient variation (CV) of 0.3% for sodium, potassium, and chloride in serum samples. In accordance with the CLSI EPOS-A3 and EP06-A2, within-laboratory precision and linearity were evaluated, and the high performances were obtained in results. Conclusion We have developed a new 900 tests/h Electrolyte Analyzer. It can analyze sodium, potassium, and chloride in serum samples by just 12 seconds with high accuracy and precision. This is industry’s top level analysis speed and accuracy. Furthermore, it uses less amounts of reagents which helps to reduce environmental impacts. This new Electrolyte Analyzer offers a practical solution for improving the efficiency and accuracy of electrolyte analysis in clinical laboratories.