日立系列生化分析仪ISE模块配套试剂的研制与应用

目的 研制日立系列全自动生化分析仪ISE模块配套试剂。方法 分析原装试剂成分、理化指标，研制参数相同的试剂，并进行相关的试验。结果 自配与原装试剂的各项成分和理化指标基本一致；使用自配与原装进口试剂测定结果之间相关性好；自配试剂的精密度、准确度、线性范围、稳定性符合要求，经过6个月使用对电极无损害。结论 自配的内标准液、参比液、稀释液可替代原装试剂用于日立生化分析仪ISE模块的测定。

Research and application of HITACHI biochemical analyzer ISE reagents

0bjective To develop the reagents of ISE module in HITACHI serial biochemical analyzers. Methods The components with physical and chemical parameters of primary ISE module reagents had been analyzed first, then the similar reagents were developed．A series of comparisons between the self-made and original reagents were observed．Results All the parameters of self-made reagents were similar to those from the original reagents．No significant difference between the two reagents had been found and satisfactory results could be achieved during six-month clinical tria1s．The precision, accuracy, linearity and stability can meet the qualifications of clinical application, respectively. No damage to the electrodes was observed after six months． Conclusions The three kinds of self-made reagents can be used to replace the imported reagent.