不同保存方法对液体质控品稳定性影响的研究  

Influences of different preservation methods on stability of liquid quality control serum

作　　者：高颖斐[1] 王玉明[1] 高颖雯 陈孝红[1] 沈巧 李美玲[1] 周涛[1] 马润[1] 张强[3] GAO Ying-fei;WANG Yu-ming;GAO Ying-wen;CHEN Xiao-hong;SHEN Qiao;LI Mei-ling;ZHOU Tao;MA Run;ZHANG Qiang(Department of Clinical Laboratory,the 2nd Affiliated Hospital of Kunming Medical University,Kunming 650101,China;Department of Women Healthcare,Panlong District Center for Women and Children Healthcare and Birth Control,Kunming 650041,China;Medical Examination Center,the 3rd Affiliated Hospital of Kunming Medical University,Yunnan Cancer Hospital,Kunming 650118,China)

机构地区：[1]昆明医科大学第二附属医院检验科,昆明650101 [2]昆明市盘龙区妇幼保健计划生育服务中心妇保科,昆明650041 [3]昆明医科大学第三附属医院云南省肿瘤医院体检中心,昆明650118

出　　处：《医疗卫生装备》2018年第9期41-45,共5页Chinese Medical Equipment Journal

摘　　要：目的:探讨不同保存方法对液体质控品稳定性的影响。方法:将美国伯乐冰冻生化液体质控品室温复融后平均分为2份,一份按需分装冷冻(冷冻组),另一份冷藏保存(冷藏组),分析总蛋白(TP)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TB)、直接胆红素(DB)、碱性磷酸酶(ALP)、胆碱酯酶(CHE)、甘油三酯(TG)、无机磷(IP)和游离脂肪酸(NEFA)的变异系数(coefficient of variation,CV)和第20天的相对变化率;并分析2015年8月至2017年9月不同批号质控品2种保存方式下的室内质控数据的CV百分比偏差。采用SPSS 22.0软件对数据进行配对t检验,P<0.05表示差异有统计学意义。结果:除冷藏组中值质控品的TP、AST的结果和冷冻组相比差异无统计学意义外,其余项目2组检测结果差异有统计学意义(P<0.01);2组中值质控品CV除TP、AST无明显差异,病理值质控品CV除TP、ALP无明显差异外,其余项目均有显著差异,冷藏组大于冷冻组;冷冻组第20天相对变化率较小,冷藏组除TP比较稳定外,其余项目均出现不同的变化趋势。2015年8月至2017年9月的室内质控数据显示,除了TP外,采用分装冷冻保存的质控品CV均明显小于采用冷藏方式保存的CV,其中ALT、AST、ALP、CHE、TB和DB的偏差较大,绝对值均>50%。结论 :分装后冷冻保存的质控品稳定性优于冷藏保存。Objective To investigate the influences of different preservation methods on the stability of the liquid quality control serum. Methods A certain amount of USA Bio-Rad frozen biochemical liquid quality control serum thawed at room temperature and then was divided equally into two groups, of which, one went through aliquot frozen and the other through refrigeration. The two groups had the indexes analyzed such as the coefficients of variation（CV） and the relative variation ratio at the 20 th day of TP, ALT, AST, TB, DB, ALP, CHE, TG, TP and NEFA as well as the CV percentage deviation of internal quality control data of batches of liquid quality control serums from August 2015 to September 2017 which were preserved at the above conditions respectively. SPSS 22.0 software was used for data paired t-test, and the difference was regarded as being significant when P value was lower than 〈0.05. Results The two groups had the results different significantly except that those on TP and AST of the medium-value quality control serum（P〈0.01）; the aliquot frozen group had the CV results statistically higher than those in the refrigeration group except those on TP and AST of the medium-value quality control serum as well as that on TP of the pathological quality control serum; in the aliquot frozen group all the items had low relative variation ratios at the 20th day, while in the refrigeration group all the items but TP had the relative variation ratios with different development trends; the internal quality control data indicated that all the items except TP from August 2015 to September 2017 had the CVs in the aliquot frozen group obviously lower than those in the refrigeration group, of which, such ones had the absolute values of the deviations higher than 50% as ALT, AST, ALP, CHE, TB and DB. Conclusion Aliquot frozen behaves better than refrigerationin terms of the stability of preserved quality control serum.

关 键 词：液体质控品 分装冷冻 冷藏 稳定性 变异系数 精密度 

分 类 号：R318[医药卫生—生物医学工程] R446.1[医药卫生—基础医学]