免疫胶体金法定量检测促甲状腺激素的实验性能测试  

Performance Assessment of Quantitative Thyroid Stimulating Hormone by Immune Colloidal Gold Assay

作　　者：王婷婷[1] 单凤玲[1] 陆汉魁[1] 

机构地区：[1]上海交通大学附属第六人民医院核医学科,上海200233

出　　处：《标记免疫分析与临床》2016年第5期567-570,578,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的免疫胶体金法用于快速检测受试者手指全血的促甲状腺素(TSH),可以定量分析且快速简便。本研究拟对免疫胶体金法定量检测TSH的精密度性能及检测仪器间是否存在差异进行实验研究。方法设计7个不同浓度的促甲状腺激素(TSH)质控品和人血清样本,每天对各样本重复测定4次,持续5天,计算重复性(批内CV)和中间精密度(CV)。选用33份不同浓度的TSH血清标本,分别用检测仪器1和检测仪器2进行判读分析,比较两者结果的相关性。结果质控品和病人血清TSH浓度为1.20、2.51、3.46、5.02、7.63、10.03、11.08μIU/m L,对应的批内CV分别为30.00%、17.84%、16.50%、15.00%、13.92%、10.62%、9.62%,中间精密度CV分别为29.23%、20.19%、18.15%、16.60%、15.34%、10.42%、8.76%。二台检测仪器检测TSH值相关性r为0.968,无统计学差异。结论免疫胶体金法定量检测TSH在低浓度TSH水平的精密度变异较大,但在中高浓度TSH尤其>10μIU/m L情况下,检测精密性能良好。不同检测仪器间检测结果也无明显差异。Objective Immune colloidal gold（ICG） assay has been applied for detecting of thyroid stimulating hormone（TSH） using finger blood.The aim of the study is to evaluate the precision and manufacture error between different instruments on ICG quantitative TSH analysis.Methods Seven TSH samples with different concentration were chosen for the study.Each sample was tested 4 times intraassay every day and lasted for 5days.The intraassay and intermediate CV（%） were calculated.In addition,33 blood samples with different TSH concentrations were tested by two ICG instruments to check their differences.Results The intraassay and intermediate CV（%） were 30.00%,17.84%,6.50%,15.00%,13.92%,10.62%,9.62% and 29.23%,20.19%,18.15%,16.60%,15.34%,10.42%,8.76% for TSH samples with concentration 1.20,2.51,3.46,5.02,7.63,10.03,11.08μIU / m L,respectively.Between two ICG instruments,the correlation coefficient was 0.968 and there was no significant difference.Conclusion The precision performance of ICG TSH assay was less stable at lowTSH concentration;when TSH ≥10.00μIU / m L the precision performance was satisfactory.No difference was found between two ICG TSH instruments.

关 键 词：精密度 促甲状腺激素(TSH) 免疫胶体金法 

分 类 号：R446.6[医药卫生—诊断学]