Preparation Of The Erythrocyte Sedimentation Rate Control Materials And Primary Evaluation

Objective:Erythrocyte Sedimentation Rate(ESR) control material is required to meet the needs of internal quality control and external quality assessment in order to assure the accuracy and comparability of the ESR test result.As there is not any internal ESR control material manufacture,the control materials supply depend on the manufacture overseas,e.g.R&D Systems,Inc.Imported control materials is very expensive and its purchasing period is very long,which is difficult to apply at clinical laboratories and correlative organizations.Therefore National Center of Clinical Laboratory intend to prepare the ESR control material through literature retrieval and to evaluate its homogeneity and stability according to ISO Guide 35 and apply to some types of Automatic Sed-rate Analyzer.At last,Internal quality control and external quality assessment is carried out by using the control materials.Methods:We studied the influence factors on the preparation of erythrocyte sedimentation rate(ESR) and established the best appropriate scheme to prepare erythrocyte sedimentation rate control material.According to ISO Guide 35 we used random sampling and selected adequate sample from the batch,then evaluated the homogeneity of the control material by a one-way analysis of variance(ANOVA) and evaluated the stability of the control material using simple linear regression model.The control material was applied to different types of Automatic Seal-rate Analyzer such as Monitor-J,XCY-ⅢA,SRS20/Ⅱand Testl.Internal quality control and external quality assessment was carried out at last by using the imported and the prepared control materials. Results:①The erythrocyte sedimentation rate control materials from human blood and porcine blood were prepared.②In the homogeneity evaluation the results showed that the difference of the within groups and between groups was insignificant(p＞0.05). The control materials' uncertainty of between-bottle homogeneity,which was calculated according to ISO Guide 35,were 2.025mm and 0.997mm respectively.At the same level,the CV of between-bottle homogeneity was 2.5%,which was less than 13.0%,the CV of imported control's between-bottle homogeneity.③A linear regression based on the stability test indicated that the linear trend was insignificant (p＞0.05).The human blood control material's uncertainty of long-term stability for a shelf life of one half year was 3.010mm(lot:20071106) and the porcine blood control material's uncertainty of long-term stability for a shelf life of five months was 1.204 mm(lot:20080113).④The control material was applied to MONITOR-J, XCY-ⅢA,Test1 and SRS20/ⅡAutomatic Sed-rate Analyzer.⑤The CV of the prepared ESR control materials in internal quality control was from 7.3%～14.0%,the CV of the imported ESR control materials was from 8.9%～13.3%.External quality assessment was carried out using the different control materials at the same time.The CV of the imported control materials was from 18.8%to 30.7%,and the CV of the prepared ESR control materials was from 21.3%to 29.5%,which was close to that of the imported control materials.Conclusion:The erythrocyte sedimentation rate control material prepared meet the needs of the homogeneity and stability of the control material with the shelf life of one half year at least.The control material is applied to MONITOR-J,XCY-ⅢA and SRS20/ⅡAutomatic Sed-rate Analyzer and inapplicable to Test1 Analyzer.The control materials is applicable to carry out internal quality control by MONITOR-J and external quality assessment in most laboratories.The prepared ESR control materials is considered to be used for external quality assessment.