摘要
目的对制备的网织红细胞计数质控物进行均匀性和稳定性评价。方法依据ISOGuide35《标准物质/标准样品的定值—通用原则和统计原理》对自制质控物的网织红细胞计数百分比进行均匀性、稳定性评价。随机抽取足够数量的样本,用单因素方差分析评价质控物的均匀性,用一元线性回归分析方法评价质控物的稳定性,并根据评价结果进行不确定度的计算。结果均匀性评价结果显示样品内和样品间的差异无统计学意义(P>0.05),两个批号的自制质控物均匀性的不确定度分别为0.372%、0.039%。稳定性数据的回归分析结果显示,质控物网织红细胞计数百分比随储存时间变化的线性趋势无统计学意义(P>0.05),两个批号质控物长期稳定性的不确定度分别为0.069%、0.031%。结论自制网织红细胞计数质控物的均匀性和稳定性符合要求。
Objective To evaluate the homogeneity and stability of the retieulocyte count quality control material. Methods According to ISO Guide 35： Reference materials-General and Statistical principles for certification, we evaluated the homogeneity and stability of prepared quality control material. Adequate samples were selected at random, evaluated the homogeneity of the quality control material hy one-way analysis of variance （ANOVA）, and the stability of the quality control material by linear regression model. The uncertainty of homogeneity and stability was evaluated. Results The resuits of the homogeneity evaluation showed that there was insignificant difference between within-groups and betweengroups （P〉0.05）. The uncertainty of homogeneity for two lots prepared quality control materials were 0. 372 % and 0. 039% respectively. A linear regression based on the stability test indicated that there was no linear trend between the assayed value and time （P〉0. 05）. The uncertainty of long-term stability for two lots prepared quality control materials were 0. 069% and 0. 031%. Conclusion The reticulocyte count quality control material prepared by us meet the requirement of the homogeneity and stability of the quality control material.
出处
《临床输血与检验》
CAS
2009年第2期113-117,共5页
Journal of Clinical Transfusion and Laboratory Medicine
基金
国家高技术研究发展计划(863计划)(No.2006AA020909)资助
关键词
网织红细胞计数
质控物
均匀性
稳定性
Reticvlocyte count Quality control material Homogeneity Stability
