全血微量元素液体质控品的制备及性能评价

目的:探讨自制全血铁(Fe)、锌(Zn)、铜(Cu)微量元素液体质控品的稳定性及作为原子吸收分光光度法室内质控品的可行性。方法:收集标本测试完后血型相同的乙二胺乙二酸(EDTA)抗凝新鲜全血,加入溶血剂,用蒸馏水稀释制备两个水平全血Fe、Zn、Cu微量元素检测用液体质控品,分装,-20℃保存,对自制全血微量元素液体质控品进行性能评价。结果:自制两个水平全血微量元素液体质控品3个项目,批内、批内天间不精密度均小于基于生物学变异导出的质量规范,符合质量控制要求,-20℃保存24个月,自制液体质控品性能稳定、可靠,差异无统计学意义(P>0.05),瓶间差CV符合美国国会颁布临床实验室修正案(CLIA'88修正案)关于质控品的技术规格的要求。结论:自制两个水平全血微量元素液体质控品,性能稳定,制作方法简单,可满足临床实验室室内质控的要求。

Preparation and evaluation of whole blood microelement liquid quality control products

Objective:To explore the stability of self-made liquid quality control products for microelement of iron(Fe),zinc(Zn)and copper(Cu)in whole blood and the feasibility of using them as indoor quality control products by atomic absorption spectrometry.Methods:The anticoagulant fresh whole blood of EDTA with the same blood type was collected after the test.The hemolytic agent was added and diluted with distilled water to prepare two levels of liquid quality control products for the detection of Fe,Zn and Cu microelements in the whole blood.The samples were separately packed and stored at-20℃,and the performance of the self-made liquid quality control products for the determination of Microelements in the whole blood was evaluated.Results:Three items of self-made whole blood microelements liquid quality control products were less than the quality standard based on biological variation in two levels,which could meet the quality control requirements.After keeping at-20℃for 24 months,the performance of self-made liquid quality control products was also stable and reliable,and the difference was not statistically significant(P>0.05).The CV of bottle difference was in line with the clinical laboratory amendment issued by the U.S.Congress.Proposal(CLIA'88 Amendment)on technical specifications of quality control products.Conclusion:The self-made two levels of whole blood microelement liquid quality control products have stable performance and simple preparation method,which can meet the requirements of clinical laboratory indoor quality control.