血清电解质钾、钠、钙、镁、氯、磷参考测量体系的建立研究

Electrolytes are vital for the body to maintain life activities. Sometime even slight abnormality may cause disorder of physiological functions. Accurate and reliable measurement results of laboratory can provide an important basis for diagnosis, prevention and treatment of disease. The results were not accurate and precise, which would affect the diagnosis and treatment of disease. So it’s urgent to carry out the standardization plan to acquire the accurate and precise test results and achieve the mutual recognition among laboratories. Because the standardization of serum electrolytes is not enough in China, the results of various methods are quite different, so it is urgent to establish reference measurement system to ensure traceability of test results. Base on previous research projects in the accurate measurement of ion, we will attempt to establish improved reference measurement methods for serum potassium, sodium, calcium, magnesium, chlorine, and phosphorus by Ion Chromatography which is simple, rapid and high sensitive. We will first choose strontium (Sr2+) and bromine (Br-) respectively as internal standards of positive ions(Na +, K +, Mg2 +, Ca2 +) and negative ions(Cl-, PO43-),which can ensure that the proposed methods are not only accurate and reliable but also simple and practical. At the same time, we will also develop serum standard reference materials of six kinds of complex inorganic ions to calibrate and evaluate conventional methods, which can solve the problem of metrological traceability. Up to now, exploration and innovation of this project in the field of detection of serum electrolytes are not reported both domestically and abroad. The completion of this project will greatly improve the clinical laboratory quality of serum electrolytes in our country, and finally realize consistency and mutual recognition of accurate detection results.

电解质对于机体生命活动的维持极为重要，即使有时发生轻微的异常，也可能造成生理功能的紊乱，其准确、可靠的实验室检测结果，能为临床诊断、疾病预防和治疗提供重要依据。由于国内目前血清电解质标准化程度不够，不同试剂方法的结果差异较大，建立参考测量体系、保证检验结果的溯源性已成为迫切需要。本项目在以往研究工作基础上，应用简单、快速、灵敏度高的离子色谱法，建立血清电解质钾、钠、钙、镁、氯、磷6种离子的参考方法。首次选用锶(Sr2+)和溴(Br-)分别作阳离子（Na+、K+、Mg2+、Ca2+）和阴离子（Cl-、PO43-）的内标，保证拟建方法在简单、实用的基础上准确、可靠。同时首次研制血清基质的6种复合离子参考物质，评价常规方法，有效解决量值溯源传递问题。本项目在血清电解质检测领域开拓创新，国内外均未见报道。项目完成将大大改进我国血清电解质临床检验质量,最终实现检测结果在准确基础上的一致性与结果互认。

电解质对于机体生命活动的维持极为重要，即使有时发生轻微的异常，也可能造成生理功能的紊乱，其准确、可靠的实验室检测结果，能为临床诊断、疾病预防和治疗提供重要依据。由于国内目前血清电解质标准化程度不够，不同试剂方法的结果差异较大，建立参考测量体系、保证检验结果的溯源性已成为迫切需要。本项目在以往研究工作基础上，应用简单、快速、灵敏度高的离子色谱法，建立了创新的基于IC法原理的血清电解质钾、钠、钙、镁的候选参考方法，同时研制了血清基质的复合离子参考物质，评价常规方法，有效解决量值溯源传递问题。. 采用回收实验对方法进行准确性评价，并根据CLSI EP15-A2，以美国国家标准及技术研究所（NIST）国际标准参考物质956c同时评估方法的精密度及正确度，根据CLSI EP6评价方法的线性。参加IFCC外部室间质评计划进一步验证方法准确性。根据CLSI EP9，40份新鲜血清在离子色谱参考方法与六大常规系统进行可比性研究。建立的IC参考方法对3水平候选标准物质进行定值，并用于北京市临床检验中心正确度验证计划。离子色谱法测血清四种阳离子回收率均在99.34%～100.74%之间；测定NIST956c Na、K、Mg、Ca离子浓度的批内标准差及室内精密度均小于1%；NIST956c四种离子定值均在验证区间内，且结果与认定值的偏倚均小于0.5%；通过本研究建立的IC参考方法参加国际临床化学联合会(IFCC)开展的2016、2017钾、钠、钙、镁EQA计划，测定结果与参加实验室检测均值偏倚均在1%以内。参考方法和常规系统测定钾、钙离子线性相关系数R2>0.995，有良好的线性关系。北京市临检中心组织的3个水平电解质正确度验证，Na离子的正确度验证通过率分别为73.91%、86.95%、91.30%；K离子通过率分别为52.17%、82.61%、34.78%；Mg离子通过率分别为86.96%、82.61%、78.26%；Ca离子通过率分别为43.48%、52.17%、47.83%。. 本项目在血清电解质检测领域开拓创新，解决目前检验结果正确性和可比性不足的问题。通过所建立的参考方法，研制我国自主品牌的参考物质,降低对进口检测技术及仪器、试剂的依赖，促进民族科技与产业的发展。项目的完成将产生明显的经济效益和社会效益。