复合血脂质控品的制备及性能评价

Preparation and performance evaluation of a composite lipid quality control material

目的研制一种液体非定值复合血脂质控品,并对其稳定性进行探讨和研究。方法采用混合人血清[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)阴性]为基质制备复合血脂质控品,并对其精密度(瓶间差)、开瓶及储存稳定性进行评价。结果自制的质控品各项目精密度(瓶间差)均<1/4美国临床实验室修正法规(CLIA’88)可接受性能指标。于-20℃条件下保存18个月,各项目偏移结果均符合1/2美国CLIA’88可接受性能指标规定。开瓶后于2～8℃保存19 d,各项目稳定性[变异系数(CV)]均<1/4美国CLIA’88可接受性能指标。结论自制质控品的均匀性和稳定性良好,可替代人血清用于临床实验室的日常质量控制(IQC)以及进行不同实验室之间的质量评价(EQA)和检测结果一致性调查使用。

Objective To prepare a liquid composite lipid quality control material without assigned value, and then to investigate its stability. Methods Pooled human serum [ negative for the antibodies to human immunodeficiency virus （HIV）, hepatitis C virus （HCV） and hepatitis B surface antigen （HBsAg）] was used as the medium for the composite lipid quality control material preparation. The precision （lot to lot difference） and stabilities after opening and in storage were evaluated. Results The precision （lot to lot difference） of the quality control material was 〈 1/4 of Clinical Laboratory Improvement Amendments （CLIA＇88） acceptable performance range. The quality control material was stable for 18 months at -20℃, and the bias of each item conformed to the 1/2 CLIA＇88 acceptable performance range. The stability [ coefficient of variation （CV） ] of each item of the opened quality control material for 19 d at 2-8℃ was 〈 1/4 CLIA＇88 acceptable performance range. Conclusions The liquid composite lipid quality control material has good homogeneity and stabihty, and it can be used for the internal quality control （IQC）, external quality assessment （EQA） and harmonization survey.