Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Aβ42/40 ratio to identify presence of brain amyloid.
Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Aβ42/40 ratio to identify presence of brain amyloid.
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临床％20验证％20的％20the％20PrecivityAD2％20blood％20测试：％20A％20mass％20基于光谱的％20测试％20与％20算法％20组合％20％p-tau217％20和％20Aβ42/40％20比率％20到％20识别％20存在
DOI：
10.1002/alz.13764
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发表时间：
2024
期刊：
影响因子：
--
通讯作者：
Batema
中科院分区：
文献类型：
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作者：
Meyer,MatthewR;Kirmess,KristopherM;Eastwood,Stephanie;Wente-Roth,TraciL;Irvin,Faith;Holubasch,MaryS;Venkatesh,Venky;Fogelman,Ilana;Monane,Mark;Hanna,Lucy;Rabinovici,GilD;Siegel,BarryA;Whitmer,RachelA;Apgar,Charles;Batema
背景随着阿尔茨海默病（AD）的疾病修饰疗法的可用性，临床医生进行测试以帮助AD诊断是很重要的，特别是当淀粉样蛋白病理的存在是接受治疗的标准时。使用基于质谱的测定法测量来自583名疑似AD患者的血液样本中的%p‐ tau 217和淀粉样β（Aβ）42/40比率（53%正电子发射断层扫描[PET]阳性，Centiloid > 25）。使用这些血浆生物标志物开发了一种算法（PrecivityAD 2检验），以通过PET鉴定脑淀粉样变性。% p-tau 217的受试者工作特征曲线下面积（AUC-ROC）（0.94）在统计学上显著高于p-tau 217浓度的受试者工作特征曲线下面积（AUC-ROC）（0.91）。PrecivityAD 2检验输出的AUC-ROC（淀粉样蛋白概率评分2）为0.94，与淀粉样蛋白PET的一致率为88%。根据种族、性别、年龄和apoE 4状态，APS 2的诊断性能是相似的。PrecivityAD 2血液测试显示出很强的临床有效性，与PET显示的脑淀粉样变性具有极好的一致性。
BACKGROUNDWith the availability of disease‐modifying therapies for Alzheimer's disease (AD), it is important for clinicians to have tests to aid in AD diagnosis, especially when the presence of amyloid pathology is a criterion for receiving treatment.METHODSHigh‐throughput, mass spectrometry‐based assays were used to measure %p‐tau217 and amyloid beta (Aβ)42/40 ratio in blood samples from 583 individuals with suspected AD (53% positron emission tomography [PET] positive by Centiloid > 25). An algorithm (PrecivityAD2 test) was developed using these plasma biomarkers to identify brain amyloidosis by PET.RESULTSThe area under the receiver operating characteristic curve (AUC‐ROC) for %p‐tau217 (0.94) was statistically significantly higher than that for p‐tau217 concentration (0.91). The AUC‐ROC for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status.DISCUSSIONThe PrecivityAD2 blood test showed strong clinical validity, with excellent agreement with brain amyloidosis by PET.