一种用于即时血糖检测的人源全血质控物研制与评价  

The preparation and evaluation of human whole blood control materials for point-of-care glucose testing

作　　者：王艳[1] 王清涛[2] 张顺利[2] 尹弘毅[2] 吴俊[1] 周睿[2] Wang Yan;Wang Qingtao;Zhang Shunli;Yin Hongyi;Wu Jun;Zhou Rui(Department of Clinical Laboratory,Beijing Jishuitan Hospital,Beijing 100035,China;Department of Clinical Laboratory,Beijing Chaoyang Hospital Affiliated to Capital Medical University,Beijing 100020,China)

机构地区：[1]北京积水潭医院检验科,北京100035 [2]首都医科大学附属北京朝阳医院检验科,北京100020

出　　处：《中华检验医学杂志》2022年第2期180-185,共6页Chinese Journal of Laboratory Medicine

基　　金：北京市医院管理局临床医学发展专项(ZYLX201805);国家临床重点专科建设项目(QTW)。

摘　　要：目的制备一种用于血糖即时检测(POCT)的人源全血质控物,并对其均匀性、稳定性及基质效应进行评价。方法将临床验后静脉全血样本分离、固定、洗涤、过滤和分装后,制备成高、中、低3个浓度的人源全血质控物,参照中国合格评定国家认可委员会(CNAS)GL29∶2010《标准物质/标准样品定制的一般原则和统计方法》对其均匀性和稳定性进行评价;在POCT血糖检测系统中,采用美国临床实验室标准化委员会(CLSI)EP14-A3中的Deming回归对其基质效应进行评价;质控物应用于室内质量控制,并计算其检测结果的变异系数(CV)。采用单因子方差分析和t检验法对检验中的结果进行统计。结果3个浓度水平质控物的均匀性良好[F<F_(0.05(9,20))];在2~8℃条件下,质控物开瓶后可稳定10 d,未开瓶15 d内的短期稳定性良好,结果与第1天比较,差异无统计学意义(P>0.05);质控物适用于10款POCT血糖检测系统,无基质效应;室内质控结果显示高、中、低3个浓度CV分别为0.63%、0.66%和1.65%,均小于7.5%。结论该自制人源全血质控物具有良好的均匀性、稳定性和适用性,可满足临床对POCT血糖检测的质量控制要求,具有较好的应用前景。Objective To prepare the control materials of point-of-care(POC)glucose testing and evaluate their homogeneity,stability and matrix effects.Methods The high,medium and low concentration control materials were prepared from patient leftover whole blood,which was centrifuged,fixed,washed,filtered,and aliquoted.The homogeneity and stability of the control materials were evaluated according to CNAS(China National Accreditation Service for Conformity Assessment,CNAS)GL29:2010"Reference materials-General and statistical principles for certification".The control materials were used to evaluate the matrix effects in POC glucose detection systems by Deming regression,according to the Clinical and Laboratory Standards Institute(CLSI)EP14-A3.Meanwhile,these control materials were used as the internal quality control,and their coefficients of variation(CV)were calculated.One-way ANOVA and t-Test were used to analyze the results.Results The homemade materials at three concentrations showed good homogeneity[F<F_(0.05(9,20))].When the control materials were stored at 2-8℃,the stable phases for the opened and closed bottles were 10 days and 15 days,respectively,and there was no statistically significant difference between the results of the first day(P>0.05).The control materials at three concentrations also showed good applicability and there were no matrix effects in 10 POC glucose systems.When the control materials were detected in the internal quality control,the CVs of the high,medium and low concentrations were 0.63%,0.66%and 1.65%,respectively,which were all below 7.5%.Conclusions The homemade human control materials of POC glucose testing showed good homogeneity,stability and applicability.They met the requirements of quality control in hospital settings,which provided a good application prospect of the quality management of POC glucose testing.

关 键 词：血糖 即时检测 质量控制 基质效应 全血 

分 类 号：R446.1[医药卫生—诊断学]