Preparation and Evaluation of the Serum Quality Control Material of β2-Microglobulin / 现代检验医学杂志

ABSTRACT

Objective To prepare quality control material of β2-microglobulin (β2 MG),then evaluate the quality of it.Methods The quality control material of β2-MG was prepared with pooled serum from patients.Then according to Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing and ISO Guide 35,the homogeneity and stability of it was evaluated.Results According to the result of homogeneity test,there was no statistically significant difference between within groups and between-groups (F=0.699,2.091,all P＞0.05) for 2 levels of quality control materi al.What was more,the stability test showed that it could stabilize for at least 5 days at 25 ℃ (t=-1.76,-2.64,all P＞ 0.05),28 days at 4 ℃ (t=-1.86,-2.44,all P＞0.05),4 months at-20 ℃ (t=0.26,-2.68,allP＞0.05),and 1 yearat -80℃ (t=-0.96,0.01,all P＞0.05).Conclusion Quality control material of β2-MG has simple preparation.The homogeneity and stability of it meets the standard requirements.