关键词: 免疫固定电泳, 室内质量控制, 质控品, 均匀性, 稳定性, 适用性

Abstract:

Objective To prepare internal quality control materials for agarose gel immunofixation electrophoresis（IFE），and to evaluate its homogeneity，stability and applicability. Methods Clinical samples were selected according to the related guidance for internal quality control materials. The negative，weak positive and positive quality control materials were made. The homogeneity，stability and applicability were evaluated. Results The homogeneity of quality control materials at 3 levels was good. The quality control materials were stored at 2-8 ℃ after opening for 4 months，and the stability was good. The quality control materials at -40 ℃ without opening had good consistency within 5 years. It had been used in other determination systems of the same brand and different determination systems of different brands，and the results were consistent. Conclusions The internal quality control materials for agarose gel IFE has good homogeneity，stability and applicability，which can meet the quality control requirements of clinical laboratories.

Key words: Immunofixation electrophoresis, Internal quality control, Quality control material, Homogeneity, Stability, Applicability