Diagnostic and prognostic performance to detect Alzheimer's disease and clinical progression of a novel assay for plasma p-tau217.
Diagnostic and prognostic performance to detect Alzheimer's disease and clinical progression of a novel assay for plasma p-tau217.
复制标题
检测阿尔茨海默病的诊断和预后表现以及血浆p-tau217新检测方法的临床进展。
DOI：
10.1186/s13195-022-01005-8
复制
发表时间：
2022-05-14
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
疾病修饰治疗的最新进展突出了准确识别早期阿尔茨海默病（AD）阶段个体和监测治疗效果的需要。磷酸化tau（p-tau）的血浆测量是AD的有希望的生物标志物，但不同的测定显示不同的诊断和预后准确性。本研究的目的是确定新型血浆p-tau 217（p-tau 217）检测试剂盒（p-tau 217 +Janssen）的临床性能，并在两个独立队列中与已确立的检测试剂盒（血浆p-tau 217 Lilly）进行头对头比较。该研究包括两个队列，队列1（27名对照和25名轻度认知障碍[MCI]患者）和队列2，包括147名基线MCI患者，平均随访4.92（SD 2.09）年。使用受试者操作特征分析评估两种检测方法检测CSF中β淀粉样蛋白状态（+/−）、区分MCI与对照以及识别将从MCI转化为AD痴呆的受试者的性能。一般线性和线性混合效应分析用于评估p-tau与基线之间的关联，以及简易精神状态检查（MMSE）评分的年度变化。使用斯皮尔曼相关性评估两种血浆测量值之间的相关性，并检查Bland-Altmann图以评估测定之间的一致性。两种检测方法在检测CSF中β淀粉样蛋白状态方面表现出相似的性能（血浆p-tau 217 +Janssen AUC = 0.91 vs血浆p-tau 217 Lilly AUC = 0.89），区分MCI与对照（血浆p-tau 217 +Janssen AUC = 0.91 vs血浆p-tau 217 Lilly AUC = 0.91），并预测未来从MCI向AD痴呆的转化（血浆p-tau 217 +Janssen AUC = 0.88 vs p-tau 217 Lilly AUC = 0.89）。两种测定与基线（血浆p-tau 217 +Janssen rho = −0.39 vs p-tau 217 Lilly rho = −0.35）和MMSE评分的年度变化（血浆p-tau 217 +Janssenr = −0.45 vs p-tau 217 Lillyr = −0.41）的相关性相似。两种血浆测量之间的相关性在队列1中为rho = 0.69，p < 0.001，在队列2中为rho = 0.70，p < 0.001。Bland-Altmann图显示两个队列中血浆p-tau 217 +Janssen和血浆p-tau 217 Lilly之间具有良好的一致性（队列1，51/52 [98%]在95%CI内;队列2，139/147 [95%]在95%CI内）。总之，我们的结果表明血浆p-tau 217 +Janssen测定具有良好的诊断和预后性能，与p-tau 217 Lilly测定相似。在线版本包含补充材料，可通过10.1186/s13195-022-01005-8获得。
Recent advances in disease-modifying treatments highlight the need for accurately identifying individuals in early Alzheimer’s disease (AD) stages and for monitoring of treatment effects. Plasma measurements of phosphorylated tau (p-tau) are a promising biomarker for AD, but different assays show varying diagnostic and prognostic accuracies. The objective of this study was to determine the clinical performance of a novel plasma p-tau217 (p-tau217) assay, p-tau217+Janssen, and perform a head-to-head comparison to an established assay, plasma p-tau217Lilly, within two independent cohorts. The study consisted of two cohorts, cohort 1 (27 controls and 25 individuals with mild-cognitive impairment [MCI]) and cohort 2 including 147 individuals with MCI at baseline who were followed for an average of 4.92 (SD 2.09) years. Receiver operating characteristic analyses were used to assess the performance of both assays to detect amyloid-β status (+/−) in CSF, distinguish MCI from controls, and identify subjects who will convert from MCI to AD dementia. General linear and linear mixed-effects analyses were used to assess the associations between p-tau and baseline, and annual change in Mini-Mental State Examination (MMSE) scores. Spearman correlations were used to assess the associations between the two plasma measures, and Bland-Altmann plots were examined to assess the agreement between the assays. Both assays showed similar performance in detecting amyloid-β status in CSF (plasma p-tau217+Janssen AUC = 0.91 vs plasma p-tau217Lilly AUC = 0.89), distinguishing MCI from controls (plasma p-tau217+Janssen AUC = 0.91 vs plasma p-tau217Lilly AUC = 0.91), and predicting future conversion from MCI to AD dementia (plasma p-tau217+Janssen AUC = 0.88 vs p-tau217Lilly AUC = 0.89). Both assays were similarly related to baseline (plasma p-tau217+Janssen rho = −0.39 vs p-tau217Lilly rho = −0.35), and annual change in MMSE scores (plasma p-tau217+Janssenr = −0.45 vs p-tau217Lillyr = −0.41). Correlations between the two plasma measures were rho = 0.69, p < 0.001 in cohort 1 and rho = 0.70, p < 0.001 in cohort 2. Bland-Altmann plots revealed good agreement between plasma p-tau217+Janssen and plasma p-tau217Lilly in both cohorts (cohort 1, 51/52 [98%] within 95%CI; cohort 2, 139/147 [95%] within 95%CI). Taken together, our results indicate good diagnostic and prognostic performance of the plasma p-tau217+Janssen assay, similar to the p-tau217Lilly assay. The online version contains supplementary material available at 10.1186/s13195-022-01005-8.
登录
查看更多内容
DOI：
10.1084/jem.20200861
发表时间：
2020-11-02
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Barthélemy NR;Horie K;Sato C;Bateman RJ
通讯作者：
Bateman RJ
影响因子：
12.7
作者：
Ashton NJ;Pascoal TA;Karikari TK;Benedet AL;Lantero-Rodriguez J;Brinkmalm G;Snellman A;Schöll M;Troakes C;Hye A;Gauthier S;Vanmechelen E;Zetterberg H;Rosa-Neto P;Blennow K
通讯作者：
Blennow K
DOI：
10.1016/s0140-6736(20)32205-4
发表时间：
2021-04-24
期刊：
Lancet (London, England)
影响因子：
--
作者：
Scheltens P;De Strooper B;Kivipelto M;Holstege H;Chételat G;Teunissen CE;Cummings J;van der Flier WM
通讯作者：
van der Flier WM
DOI：
10.1002/alz.12236
发表时间：
2021-05
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
Karikari TK;Emeršič A;Vrillon A;Lantero-Rodriguez J;Ashton NJ;Kramberger MG;Dumurgier J;Hourregue C;Čučnik S;Brinkmalm G;Rot U;Zetterberg H;Paquet C;Blennow K
通讯作者：
Blennow K
DOI：
10.1007/s00259-021-05253-y
发表时间：
2021-07
影响因子：
9.1
作者：
Ashton NJ;Leuzy A;Karikari TK;Mattsson-Carlgren N;Dodich A;Boccardi M;Corre J;Drzezga A;Nordberg A;Ossenkoppele R;Zetterberg H;Blennow K;Frisoni GB;Garibotto V;Hansson O
通讯作者：
Hansson O