Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
The MIND Center, University of Mississippi Medical Center, Jackson, Mississippi, USA.
Alzheimers Dement. 2024 Sep;20(9):6506-6516. doi: 10.1002/alz.14140. Epub 2024 Jul 19.
We aimed to evaluate clinical interpretation cutpoints for two plasma phosphorylated tau (p-tau)217 assays (ALZpath and Lumipulse) as predictors of amyloid status for implementation in clinical practice.
Clinical performance of plasma p-tau217 against amyloid positron emission tomography status was evaluated in participants with mild cognitive impairment or mild dementia (n = 427).
Using a one-cutpoint approach (negative/positive), neither assay achieved ≥ 90% in both sensitivity and specificity. A two-cutpoint approach yielding 92% sensitivity and 96% specificity provided the desired balance of false positives and false negatives, while categorizing 20% and 39% of results as indeterminate for the Lumipulse and ALZpath assays, respectively.
This study provides a systematic framework for selection of assay-specific cutpoints for clinical use of plasma p-tau217 for determination of amyloid status. Our findings suggest that a two-cutpoint approach may have advantages in optimizing diagnostic accuracy while minimizing potential harm from false positive results.
Phosphorylated tau (p-tau)217 cutpoints for detection of amyloid pathology were established. A two-cutpoint approach exhibited the best performance for clinical laboratory use. p-tau217 assays differed in the percentage of results categorized as intermediate.
我们旨在评估两种血浆磷酸化 tau（p-tau）217 检测方法（ALZpath 和 Lumipulse）的临床解释切点，作为在临床实践中预测淀粉样蛋白状态的指标。
在轻度认知障碍或轻度痴呆患者（n=427）中，评估了血浆 p-tau217 对淀粉样蛋白正电子发射断层扫描（PET）状态的临床性能。
使用单点（阴性/阳性）方法，两种检测方法的敏感性和特异性均未达到≥90%。采用两点切点法可达到 92%的敏感性和 96%的特异性，在假阳性和假阴性之间取得了理想的平衡，同时将 Lumipulse 和 ALZpath 检测结果分别归类为 20%和 39%的不确定结果。
本研究为血浆 p-tau217 用于确定淀粉样蛋白状态的临床应用提供了一个系统的检测方法切点选择框架。我们的研究结果表明，两点切点法在优化诊断准确性的同时，最大限度地减少假阳性结果带来的潜在危害可能具有优势。
确立了用于检测淀粉样蛋白病理的磷酸化 tau（p-tau）217 切点。两点切点法在临床实验室应用中表现出最佳性能。两种 p-tau217 检测方法在中间结果的比例上有所不同。
