朗道血清质控品作为ELISA法检测血清可溶性ST2室内质控物的可行性探讨  

Feasibility Study on RANDOX Serum Quality Control Products as ELISA Method to Detect Serum Soluble ST2 Internal Quality Control Materials

作　　者：李全双[1] 许靖 吴燕[1] 王书安 杨艳君 LI Quan-shuang;XU Jing;WU Yan;WANG Shu-an;YANG Yan-jun(Xuzhou Central Hospital/Xuzhou Institute of Medical Sciences,Jiangsu Xuzhou 221006,China)

机构地区：[1]徐州市中心医院/徐州市医学科学研究所,江苏徐州221006

出　　处：《现代检验医学杂志》2022年第5期190-193,共4页Journal of Modern Laboratory Medicine

摘　　要：目的 探讨朗道血清质控品作为酶联免疫吸附(enzyme-linked immunosorbent assay,ELISA)法检测血清可溶性生长刺激表达基因2蛋白(soluble growth stimulation expressed gene 2 protein,sST2)室内质控物的可行性。方法 连续性倍比稀释试剂盒中的sST2标准品来确定标准值和空白。使用双抗体夹心ELISA法检测sST2浓度,结果用线性回归拟合,建立标准曲线并计算相关系数(r),确定线性范围。取朗道血清质控品中值Level 2和高值Level3进行纯水复溶,分别混合均匀后用无菌EP管分装,-20℃冷冻保存。参照中国合格评定国家认可委员会发布的《CNAS-GL03能力验证样品均匀性和稳定性评价指南》,首先进行均匀性验证,从分装的中值Level 2质控品中随机抽取10管,重复检测两次,用单因素方差分析比较两次测量值;然后进行稳定性验证,随机取中值Level 2质控品6管,每管重复检测两次,将所得均值作为初始均值,分别于第3,6,9和12个月随机抽取6管,同样方法获得均值并分别与初始均值进行t检验比较。高值Level 3评价方法与Level 2相同。结果 在3.125~200.0 ng/ml范围区间,按标准品sST2的结果建立标准曲线(r=0.99)。在均匀性检验中,中值Level 2和高值Level3中的F值分别为1.932,0.519,P值分别为0.181,0.481,差异均无统计学意义(均P>0.05)。在中值Level 2和高值Level 3中sST2的初始均值分别是20.03 ng/ml,22.01 ng/ml。在中值Level 2中,第3,6,9和12个月的均值分别与初始均值进行t检验(t=0.857,0.506,0.683,1.144;P=0.412,0.624,0.510,0.279),差异均无统计学意义(均P>0.05);同样在Level 3中,t值分别为0.260,0.639,0.660,1.372;P值分别为0.800,0.537,0.524,0.200,差异均无统计学意义(均P>0.05)。结论 在朗道血清质控品中值Level 2和高值Level 3中,sST2的浓度均较低且均匀性和稳定性好,因此二者均可以作为sST2低值质控品。Objective To explore the feasibility of Randox serum quality control products as soluble growth stimulation expressed gene 2 protein(sST2)internal quality control materials.Methods The standard values and blank were determined by diluting the sST2 standard in the kit by serial dilutions.Double-antibody sandwich enzyme-linked immuno sorbent assay(ELISA)was used to detect the concentration of sST2,the results were fitted with linear regression.The standard curve was established and the correlation coefficient(r)was calculated to determine the linear range.The median-value Level 2 and highvalue Level3 of RANDOX serum quality control products were reconstituted with pure water,mixed them evenly,sub pack them with sterile EP tube and freeze them at-20℃.According to the “CNAS-GL03 Guidelines for the Evaluation of Homogeneity and Stability of Proficiency Testing Samples”issued by the China National Accreditation Service for Conformity Assessment,10tubes were randomly selected from the Level 2 quality control materials for homogeneity verification firstly,repeated the test twice,and used one-way analysis of variance for homogeneity test.Then 6 tubes of Level 2 quality control were randomly selected for stability verification,each tube was tested twice,and the average value obtained was used as the initial monthly average,and 6 tubes were randomly selected at the 3rd,6th,9th and 12th months.Finally,these average values were obtained by the same method and compared with the initial average value by t test.The evaluation method of Level 3 was the same as that of Level 2.Results In the range of 3.125 ng/ml to 200.0 ng/ml,the standard curve established by the results of the standard sST2(r=0.99).In the homogeneity test,values of Level 2 and level 3 were 1.932,0.519 respectively,and the difference was not statistically significant(P = 0.181,0.481,all P>0.05).The initial mean values of sST2 were 20.03 ng/ml and 22.01 ng/ml in Level 2 and Level 3,respectively.In the Level 2,the mean values of the 3rd,6th,9th,and 12th month

关 键 词：可溶性生长刺激表达基因2蛋白(sST2) 质控品 室内质控(IQC) 

分 类 号：R446[医药卫生—诊断学]