临床血清磷酸化Tau蛋白检测结果回顾及试剂盒分析-东南大学学报医学版

临床血清磷酸化Tau蛋白检测结果回顾及试剂盒分析

作者：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² 3

单位：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

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;R446.11

出版年·卷·期（页码）：2024·43·第二期（256-262）

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.

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