血液透析液中钙离子快速检测试剂盒的研制与应用

Development and Application of Rapid Detection Kit for Calcium Ion in Hemodialysis Solution

目的研制出一种血液透析液中钙离子快速检测试剂盒,其检测方法简便快捷,可准确快速确定透析液中钙离子是否符合YY0598-2015《血液透析相关及治疗用浓缩物》标准的规定。方法参考GB/T 15452-2009工业循环冷却水中钙、镁离子的测定EDTA滴定法标准检验方法中钙离子的检测方法,根据透析液不同的钙离子浓度标示量(钙离子浓度分别为1.25 mmol/L、1.50 mmol/L和1.75 mmol/L)确定合适的试剂剂量,将所有试剂分类拼装成试剂盒,并对本试剂盒与标准检测方法测定的结果进行比较。结果该试剂盒检测结果与国标法检测结果一致,试剂盒在常温条件下至少可保存1年。结论该试剂盒方法准确快速,具有良好的应用前景。

ObjectiveA rapid detection kit for calcium ion in hemodialysis solution was developed. The detection method is simple and accurate. It can accurately determine whether calcium ions in dialysate meet the requirements of YY0598-2015 ＂Concentrates for hemodialysis and related therapies＂. MethodsBased on the national standard GB/T 15452-2009 （Industrial circulating cooling water-Determination of calcium and magnesium-EDTA titration method）-Calcium ion detection method, the appropriate dose of the reagent was determined according to the different concentration of calcium ion in dialysate （concentration of 1.25 mmol/L, 1.50 mmol/L and 1.75 mmol/L for calcium ion）, and the kit was successfully made with all reagents. Then the results of the kit and standard detection methods were compared. ResultsThe results of the kit were consistent with those of the national standard method. The kit can be stored at room temperature for at least one year. ConclusionThe kit method, capable of fast detection with high accuracy, has a promising application prospect.