同型半胱氨酸质控品的制备和性能评价

摘要

Objective To prepare a liquid internal quality control material for homocysteine (Hcy) without assigned value,and to investigate its performance. Methods Pooled human serum was used as the medium of the quality control material for Hcy.The homogeneity and stability of quality control material were evaluated according to CNAS-GL03. The self-made quality control material was also used in internal quality control and was compared with RANDOX quality control material. Results The homogeneity and stability of the self-made quality control material met related requirements.Compared with RANDOX quality control material,there was no statistical significance (P>0.05). Conclusions The self-made quality control material for Hcy has good homogeneity and stability,and it can be used for the internal quality control in clinical laboratories.%目的 研制一种液体非定值同型半胱氨酸(Hcy)室内质控品,并初步评价其性能.方法 采用混合人血清为基质制备Hcy质控品,依据CNAS-GL03的要求对其均匀性、稳定性进行评价.将自制质控品应用于室内质量控制,并与朗道质控品进行比较.结果 自制质控品均匀性和稳定性检测结果均符合要求,与朗道质控品比较,差异无统计学意义(P>0.05).结论 自制质控品具备较好的均匀性和稳定性,可用于临床实验室的室内质量控制.