临床血清磷酸化Tau蛋白检测结果回顾及试剂盒分析  

Clinical serum phosphorylated protein Tau test results and assay kit analyses

作　　者：陈德柱 陶月[2] 蔡敏琪 古慕峰[4] 孙志明 顾寿永 姜坤 柏兵 CHEN Dezhu;TAO Yue;CAI Minqi;Gu Mufeng;SUN Zhiming;GU Shouyong;JIANG Kun;BAI Bing(Department of Nuclear Medicine,Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University,Nanjing 210008,China;Department of Laboratory Medicine,Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University,Nanjing 210008,China;Department of Laboratory Medicine,Nanjing Drum Tower Hospital Clinical College of Jiangsu University,Nanjing 210008,China;Laboratory of Human Anatomy Department of Human Anatomy Nanjing Medical University,Nanjing 211166,China;National Health Commission Contraceptives Adverse Reaction Surveillance Center,Jiangsu Health Development Research Center,Jiangsu Provincial Medical Key Laboratory of Fertility Protection and Health Technology Assessment,Nanjing 210036,China;Institute of Geriatric Medicine,Jiangsu Province Geriatric Hospital,Nanjing 210024,China)

机构地区：[1]南京医科大学鼓楼临床医学院核医学科,江苏南京210008 [2]南京大学医学院附属鼓楼医院检验科,江苏南京210008 [3]江苏大学鼓楼临床医学院检验科,江苏南京210008 [4]南京医科大学人体解剖学系,南京医科大学人脑组织库,江苏南京211166 [5]国家卫生健康委计划生育药具不良反应监测中心,江苏省卫生健康发展研究中心,江苏省生育力保护与卫生技术评估重点实验室,江苏南京210036 [6]江苏省老年病医院,江苏南京210024 [7]南京医科大学鼓楼临床医学院检验科,江苏南京210008

出　　处：《东南大学学报（医学版）》2024年第2期256-262,共7页Journal of Southeast University(Medical Science Edition)

基　　金：国家自然科学基金资助项目(82172354);江苏省卫健委医学科研(M2021012)及老年健康科研(LK2021028);江苏省卫生健康发展研究中心(JSHD2022006);南京市卫生科技发展专项资金(ZKX22013);南京鼓楼医院临床研究专项资金(2022-LCYJ-MS-02);科技部科技创新2030-脑科学与类脑研究(2021ZD0201100,2021ZD0201104)。

摘　　要：目的:对南京鼓楼医院检验科所开展的血清磷酸化Tau蛋白(p-Tau)检测结果进行回顾,并分析可能存在的问题,提供对该检测方法更加全面的认识。方法:收集已有的检测数据,对其进行疾病诊断分类,并观察阿尔茨海默病、认知减退、痴呆及其它各类疾病下的p-Tau阳性率。利用细胞与脑组织类参照样品对该方法试剂盒的性能进行初步验证。结果:共包括546例患者数据。其中诊断为阿尔茨海默病的患者p-Tau阳性率为16.7%,诊断为痴呆和认知功能减退的患者阳性率为23.7%、12.1%。试剂盒对梯度稀释于血清中的参照品不能有效显示线性,不能有效检测出细胞与脑组织参照样品中的p-Tau,对手工加入临床血清标本中的参照品也不能提供预期的叠加值,显示较差的回收率。结论:该试剂盒对p-Tau检测的阳性率较低,其准确性仍需要改进并提高。Objective:To evaluate the clinical serum phosphorylated protein Tau(p-Tau)test in diagnosis of Alzheimer's disease and analyze the potential problems for better understanding of this test.Methods:All the result data of this test that have been completed in Department of laboratory Medicine,Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University were collected.The percent of positive results under each categorized diagnosis were summarized.The cultured cells and the human brain tissues that express protein Tau were used as the reference samples to verify the accuracy of the test kit.Results:546 cases in total were collected.The percentage of p-Tau positive results in patients with diagnosis of Alzheimer's disease was 16.7%,and 23.7% and 12.1% in those with diagnosis of cognitive decline and dementia respectively.The results of serially diluted kit reference standards tested by this kit did not show linear relationship.The kit failed to detect the p-Tau expressed in both cell and brain tissue samples.The additional values of the kit reference standard spiked into clinical serum samples were not closely reflected in the results after testing by this kit,demonstrating an unsatisfactory recovery.Conclusion:The current serum p-Tau test in our clinical laboratory for diagnosis of Alzheimer's diseases is not efficient and the accuracy of the kit needs to be improved.

关 键 词：阿尔茨海默病 痴呆 认知障碍 血清磷酸化Tau蛋白 

分 类 号：R749.13[医药卫生—神经病学与精神病学] R446.11[医药卫生—临床医学]