D-二聚体质控品的制备及性能评价

摘要

Objective To prepare a liquid composite quality control material of D-dimer,and then to inves-tigate its stability.Methods Pooled human serum without infection[negative for the antibodies to human im-munodeficiency virus(HIV),hepatitis C virus(HCV)and hepatitis B surface antigen(HBsAg),TP-IgG]was used as the medium for the composite quality control material preparation to investigate its precision and sta-bility.Results The within-run precision of our product was 1.83% which was < 1/4 CLIA'88 acceptable per-formance range.The between-run precision was 3.02% which was < 1/3 CLIA'88 acceptable performance range.The quality control material was stable for 12 months at -20 ℃.The stability[coefficient of variation (CV%)of each item of the quality control material was<1/2 CLIA'88 acceptable performance range.Conclu-sion T he liquid composite lipid quality control material has good homogeneity and stability,and it can be used for D-dimer testing the internal quality control.%目的 研制一种D-二聚体质控品,并对其稳定性进行评价.方法 采用无传染标志[人类免疫缺陷病毒(HIV)抗体、丙型肝炎病毒(HCV)抗体、乙型肝炎表面抗原(HBsAg)、梅毒抗体等均为阴性]混合血浆制备质控品,并对其精密度、稳定性进行评价.结果 自制的质控品批内及批间不精密度结果分别为1.83%、3.02%,均符合1/4 CLIA'88及1/3 CLIA'88可接受性能指标规定.于-20 ℃条件下保存12个月,偏移结果和瓶间均一性(变异系数)均符合1/2 CLIA'88可接受性能指标规定.结论 自制质控品的均一性和稳定性良好,可用于D-二聚体检测室内质量控制.