β2-微球蛋白血清质控物的制备及评价

摘要

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.%目的 制备β2微球蛋白(β2MG)质控血清并对其进行质量评价.方法 收集病人混合血清样本制备β2-MG质控物,并依据《能力验证样品均匀性和稳定性评价指南》和ISO Guide 35标准对其均匀性及稳定性进行评价.结果 均匀性检验结果显示制备的2个浓度水平质控物样品内和样品间均匀性差异无统计学意义(F=0.699,2.091,均P＞0.05).在室温条件下保存至少稳定5天(t=-1.76,-2.64,均P＞0.05);4℃储存条件下至少稳定28天(t=-1.86,-2.44,均P＞0.05);-20℃储存条件下至少稳定4个月(t=0.26,-2.68,均P＞0.05);-80℃储存条件下至少稳定1年(t=-0.96,0.01,均P＞0.05).结论 自制的β2微球蛋白质控血清制备方便,其均匀性、稳定性符合标准要求.