自配COULTER流式细胞仪试剂稳质期的探讨

Stability of Self-made Reagents for COULTER Flow Cytometry

探讨自配美国Coulter流式细胞仪试剂的稳质期,以便更好地进行推广应用。将自配全血溶解试剂、鞘液及清洗液保存1个月、2个月、6个月、1年,分别从其外观、理化性质、准确度、精密度和相关性等方面与进口原装试剂进行系统的比较,确定自配试剂的稳质期。自配试剂保存1年,其外观无变化,理化性质与原装试剂基本一致;连续10天测定质控品淋巴细胞亚群表达率,其CV值均小于5%;分别检测20例样本中T细胞亚群表达率,与原装试剂比较,两者结果差异均无统计学意义(P>0.05),并且两者结果呈高度正相关,r均大于0.930。这表明自配全血溶解试剂、鞘液及清洗液试剂的稳质期至少在一年。

To explore the stability of self-made reagents for COULTER flow cytometry, the original imported and self-made hemolytic reagent, sheath fluid and cleaning fluid were kept for 1,2, 6 and 12 months. The appearance, physical and chemical properties, accuracy, precision and relevance of self-made reagent were compared with that of original imported reagents. The results showed that the appearance of reagents has no change after one year; the physical and chemical properties of self-made reagents are basically the same as the original imported reagents. The measurements result by using self-made reagents has no significant different with that of original imported reagents. There was a highly positive correlation between them （ r = 0. 930）. The results indicate that the self-made reagents for flow cytometry are at least stable for one year.