造血干细胞计数全血质控物的研制与评价

Preparation and evaluation of whole blood quality control materials for CD34^+ cell enumeration

目的评价自制造血干细胞计数全血质控物的均匀性及稳定性。方法依据CNAS-GL03及ISO Guide 35的要求,对两个批号自制质控物的均匀性、稳定性进行评价,同时检测进口质控物作为对照。结果均匀性评价结果显示两批号自制质控物样品间差异均无统计学意义(P>0.05);稳定性评价结果显示20111101、2011111批号自制质控物随保存时间的延长均无线性趋势变化(P>0.05);各批号自制质控物及进口质控物长期稳定性的不确定度分别为0.023%、0.015%和0.012%。结论自制造血干细胞计数质控物的均匀性及稳定性良好。

Objective To evaluate the homogeneity and stability of homemade whole blood quality control materials for CD34＋cell enumeration prepared by National Center for Clinical Laboratory. Methods According to CNAS-GL 03 and ISO Guide 35,homogeneity and stability of homemade quality control materials were evaluated;and simultaneously,imported quality control materials were evaluated for comparison. Results Homogeneity evaluation of homemade quality control materials showed that difference between groups was insignificant（P 0.05）.A linear regression based on stability evaluation indicated that the linear trend was insignificant（P 0.05）.The uncertainty of long-term stability for homemade quality control materials（Batch NO.20111101 and 20111110）and imported quality control materials were 0.023%,0.015% and 0.012% respectively. Conclusions Homemade self-prepared whole blood quality control materials for CD34＋ cell enumeration have a good performance on homogeneity and stability.