全血七种微量元素质控品的配制及评价方案探讨  

Preparation and evaluation of standards for whole blood trace elements detection

作　　者：陶然[1] 高红[1] 莫南勋[1] 王家健[1] 文国学[1] 

机构地区：[1]广州金域医学检验中心有限公司,510330

出　　处：《中华检验医学杂志》2017年第4期284-288,共5页Chinese Journal of Laboratory Medicine

摘　　要：目的探讨全血七种微量元素（镁、锰、铁、铜、锌、铅、钙）质控品的实验室自配方案和性能评估。方法以肝素钠抗凝小牛全血为基质，根据各元素目标浓度添加金属盐或标准液，经防腐、混匀分装处理后制成全血质控品，观察抗菌效果，依据CNAS－GL03评估均匀性、稳定性，依据CLSI EP14文件判断基质效应，应用效果的评估包括检测变异（CV）的比较和标准差指数（SDI）的计算。结果自配全血元素质控品最终浓度达到目标浓度，无菌实验通过，均匀性和稳定性结果表明该质控品基质均匀并至少稳定一年。另外，除铅外其他元素的基质效应可忽略，自身历史比对和室间比对的结果表明该质控品表现与商业质控品无明显差异。结论本次全血七种元素质控品（镁、锰、铁、铜、锌、铅、钙）的配制和评估方案可行，按照该自配方案配置和评估通过的全血元素质控品可同商业质控品一样进行医学实验室元素检测的室内质控。ObjectiveTo explore the methods of preparing whole blood control of seven trace elements （magnesium, manganese, iron, copper, zinc, lead, calcium） in laboratory and evaluate its performance.MethodsHeparin sodium anticoagulant calf whole blood was used as substrateMetal salt or standard solution with target concentration of each element was added .And whole blood control product was made after process of anticorrosion, mixing and sub-packaging.Antibacterial effect was observed , uniformity and stabilitywasevaluatedaccording to CNAS-GL03 and matrix effects was evaluatedaccording to CLSI EP14.SDI （standard deviation index） and detection coefficient of variation（CV）were calculated to evaluateapplication effectiveness.ResultsLaboratory preparation of whole blood control reached target concentration, sterility tests was qualified, results of uniformity and stability indicated that the substrate was even and stable at least for one year. Besides, matrix effects of other six elements can be ignored except lead. Historical and inter-laboratory comparisons had shown that laboratory preparation of whole blood control has no obvious difference with commercial ones in performance.ConclusionThe formulation and evaluation scheme of whole blood control of seven trace elements （magnesium, manganese, iron, copper, zinc, lead, calcium） was feasible and can be used as commercial ones for elementary tests in medical laboratory.

关 键 词：痕量元素 临床实验室技术 血液化学分析 参考标准 质量保证 卫生保健 

分 类 号：R446.11[医药卫生—诊断学]