Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Department of Neurology, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
J Alzheimers Dis. 2022;90(3):993-996. doi: 10.3233/JAD-215592.
After years of anticipation, non-invasive tests for detecting cerebral amyloidosis and Alzheimer's disease (AD) are entering clinical care. The PrecivityADtrademark test from C2N is a plasma-based test yielding an Amyloid Probability score with high sensitivity and specificity for brain amyloid accumulation, but some samples may have inconclusive results. The AGREEDementia consortium raised concerns that the field needs study of how best to use and communicate results of PrecivityADtrademark. Continued attention and mindfulness should be applied to the whole class of dementia biomarker tests and directed in light of FDA biomarker context of use framework. Unintended uses of biomarkers tests may have unintended consequences, such as mislabeling patients. AD biomarker tests may efficiently stratify AD risk but will inevitably be included in electronic medical records and be subject to interpretation by medical personnel lacking proper knowledge or context to interpret results appropriately. Another way forward is mindful discussion and consensus among all stakeholders about the uses and limits of each specific test.
经过多年的期待，用于检测脑淀粉样蛋白和阿尔茨海默病 (AD) 的非侵入性测试正在进入临床护理。C2N 的 PrecivityAD 商标测试是一种基于血浆的测试，可提供高灵敏度和特异性的脑淀粉样蛋白积累的淀粉样蛋白概率评分，但某些样本可能结果不确定。AGREEDementia 联盟担心该领域需要研究如何最好地使用和传达 PrecivityAD 商标的结果。应该继续关注并牢记整个痴呆生物标志物测试类别，并根据 FDA 生物标志物使用情况框架进行指导。生物标志物测试的意外用途可能会产生意想不到的后果，例如错误标记患者。AD 生物标志物测试可以有效地对 AD 风险进行分层，但不可避免地会包含在电子病历中，并由缺乏适当知识或背景来适当解释结果的医务人员进行解释。另一种方法是所有利益相关者之间就每个特定测试的用途和限制进行深思熟虑的讨论和达成共识。
