特种蛋白液态质控血清的制备及应用评价

The preparation and application evaluation of liquid quality control serum for special protein

目的探讨自制特种蛋白液态质控血清的方法及其在室内质控中的应用价值。方法收集生化检验后剩余的新鲜血清,通过冰冻、透析浓缩血清中的蛋白成分,制成高、低值特种蛋白质控血清,以乙二醇为稳定剂,保存于-20℃,7 d后仍保持液态的乙二醇浓度作为质控血清的保存浓度;于第1 d、第7 d、第14 d、第21 d、第28 d、第60 d、第90 d取出高、低值质控血清各10管,测定Ig G、Ig A、Ig M、C3、C4、PA、Apo A、Apo B、CRP、AAG,观察特种蛋白的稳定性;每天取出高、低值质控血清各1管测定以上特种蛋白,共90 d,观察精密度,并与冻干血清进行比较。结果血清与乙二醇的比例为10∶3(V/V)时,质控血清在-20℃保持液态;特种蛋白在90 d观察期共7批检测结果的均值比较差异均无统计学意义(P>0.05);特种蛋白90 d的CV均<2%,低于冻干血清的CV。结论自制特种蛋白液态质控血清稳定性好,使用方便,精密度高,可用于临床实验室特定蛋白测定的室内质控。

Objective To explore the preparation method of self-made liquid quality control serum for special protein and its application value for internal quality control in clinical biochemistry laboratory. Methods The fresh serum was collected from hospital inpatient and outpatient remainder serum after routine clinical chemistry tests and the methods of freezing and dialysis were used to prepare the high value and low value serum and the polyethylene glycol（ PEG） was used as stabilizer. The prepared control serum was split charging in small tubes and stored in-20°C and the concentration of PEG that still keep the liquid state of the quality control serum after 7 day was used as the concentration to preserve the quality control serum. The stability was evaluated by 10 tubes of every high value and low value quality control serum,which were took out to measure the Ig G,Ig A,Ig M,C3,C4,PA,Apo A,Apo B,CRP,AAG on the 1st,7th,14 th,21st,28 th,60th,90 th day and the precision was determined by measured the special proteins in every days in total 90 days and was compared with the freeze-dried control serum.Results The ratio of serum and PEG reached 10∶3（ V / V） which could keep the serum liquid state in-20 ℃. The self-made liquid control serum had good stability,the results of 7 lots in 90 days had not statistical significance on the differences（P〉0. 05）; The CV of special proteins in 90 days was under 2%,lower than the freeze-dried control serum.Conclusion The self-made special protein fluid quality control serum had good stability,easy to use,good precision,cheaply-priced,and it could be used for special protein internal quality control in clinical laboratory.