摘要
目的调查研究目前国内胰岛素(INS)放射免疫检测系统的现状。方法首先收集门诊及住院患者血清标本140份,选用E170电化学发光免疫分析仪和四种国产INS放射免疫诊断试剂盒(国产a、b、c、d)对上述血清进行检测,根据E170检测的血清INS水平特点,把检测数据分为四组;其次,人工配制低、高浓度INS混合血清2份,分别用国产放免诊断试剂盒重复检测20次并计算批内变异系数(CV%);另外又收集E170检测血清INS≤10μIU/mL血清68份,用国产a试剂盒检测,然后对二者结果进行回归分析,所得回归方程用来校正国产a水平1组INS数据,再将校正后数据与E170数据做配对t检验以及相关性分析。结果 (1)对四种国产放射免疫诊断试剂盒INS检测结果进行方差分析,四个水平组的F值分别是46.7、13.8、9.6、9.2,P值均小于0.001。(2)四种国产试剂低和高浓度混合血清批内CV%均控制在10%以内。(3)与E170检测结果(5.4±2.5)μIU/mL相比,校正后国产a试剂检测水平1组血清INS含量为(5.6±1.6)μIU/mL,二者相比无统计学差异(t=0.49,P>0.05),校正前后相关系数r均为0.49。结论国产胰岛素放射免疫检测系统间缺乏可比性和溯源性,需要建立一个完善的INS参考系统来提高检测系统的溯源性,以保证检测结果的准确度。
Objective To investigate the current status of domestic radioimmunoassay（RIA） measurement systems for serum insulin.Methods The serum insulin levels in 140 patients were measured by using four kinds of domestic radioimmunoassay kits and E170 electrochemiluminescence system respectively.The measured results of serum insulin levels were divided into four groups according to the results of E170.The detection of insulin levels in two serum samples mixed from lowest and highest groups were repeated for 20 times by using four domestic RIA kits.The intra-batch coefficient of variability（CV%） was also calculated.The other 68 serum samples with insulin levels less than 10 μIU/mL determined by E170 were measured by the domestic kit ＂A＂,and then the linear regression was calculated between these two measurement systems.The data were analysed by using paired t-test.Results The significant differences among the four kinds of domestic kit were observed in all four levels of serum insulin by ANOVA analysis.The F value was 6.7,13.8,9.6 and 9.2 respectively（P0.001）.The intra-batch CV% for all the four kinds of domestic kit was within 10%.Compared with insulin level determined by E170,the corrected value for domestic kit ＂A＂ were not significantly different（P0.05）,the correlation coefficients before and after the correction were 0.49.Conclusion As the incomparability and the intractability exist in four kinds domestic RIA measurement systems,establishing a reference system to improve the accuracy is necessary.
出处
《标记免疫分析与临床》
CAS
2012年第4期237-240,共4页
Labeled Immunoassays and Clinical Medicine
基金
国家自然科学基金资助项目(30971405)
关键词
检测系统
胰岛素
糖尿病
溯源性
Measurement system
Insulin
Diabetes
Traceability
