›› 2013, Vol. 28 ›› Issue (5): 430-433.DOI: 10.3969/j.issn.1673-8640.2013.05.022

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Preparation and performance evaluation of a composite lipid quality control material

  

  1. 1. Shanghai Center for Clinical Laboratory,Shanghai 200126,China;2. Shanghai Yihua Medical Science and Technology Limited Company,Shanghai 201203,China
  • Received:2012-07-04 Revised:2012-08-23 Online:2013-05-15 Published:2013-05-14

Abstract: 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 stability, and it can be used for the internal quality control (IQC), external quality assessment (EQA) and harmonization survey.

Key words: Quality control material , Lipid , Stability