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Evaluation on the Homogeneity and Stability of the Reticulocyte Count Quality Control Material

ZHU Xiao-xue,PENG Ming-ting,SHI Li-fei,et al.Beijing Union Medical College,Beijing Hospital,National Center for Clinical Laboratories,Beijing 100730  
Objective To evaluate the homogeneity and stability of the reticulocyte 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 by 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 results of the homogeneity evaluation showed that there was insignificant difference between within-groups and between-groups(P0.05).Theuncertaintyofhomogeneityfortwolotspreparedqualitycontrolmaterialswere0.372%and0.039% respectively.A linear regression based on the stability test indicated that there was no linear trend between the assayed value and time(P0.05).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.
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