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
陈德柱 1陶月 2蔡敏琪 3古慕峰 4孙志明 5顾寿永 6姜坤 7柏兵8
作者信息
- 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
- 8. 南京大学医学院附属鼓楼医院 检验科,江苏 南京 210008;江苏大学鼓楼临床医学院 检验科,江苏 南京 210008
- 折叠
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.
Abstract
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 Clin-ical College of Nanjing Medical University were collected.The percent of positive results under each categorized di-agnosis 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Key words
Alzheimer's disease/dementia/cognitive decline/serum phosphorylated Tau引用本文复制引用
基金项目
国家自然科学基金资助项目(82172354)
江苏省卫健委医学科研(M2021012)
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(2021ZD0201100)
科技部科技创新2030(2021ZD0201104)
出版年
2024
NETL
NSTL
维普
万方数据