澳大利亚治疗产品管理局已批准新型血液检测用于临床诊断阿尔茨海默病 [1]。这些检测通过识别与该病相关的脑部生物标志物（如磷酸化tau蛋白217）来工作，无需采用侵入性脑成像或腰椎穿刺等传统诊断方法 [1]。悉尼NeuRA研究机构已建立亚太阿尔茨海默病诊断卓越中心以推动该技术的应用 [1]。
然而，这些血液检测存在明确的使用局限。检测目前不能单独确诊阿尔茨海默病，必须与临床症状、认知测试和其他检查相结合才能做出诊断 [1]。此外，这些检测仅适用于已出现持久认知症状或轻度认知障碍的患者，不推荐用于无症状的健康人群进行常规筛查 [1]。患者需要自付费用，因为这些检测目前不在医疗保险覆盖范围内 [1]。值得注意的是，阿尔茨海默病相关的脑部生物学变化可能在症状出现数年前就已开始发展 [1]。
Australia's Therapeutic Goods Administration has approved blood tests for Alzheimer's disease for clinical diagnostic use, marking a significant development in early detection methodology.[1] The approval has led to the establishment of an Asia-Pacific Center of Excellence for Alzheimer's diagnosis at Sydney's NeuRA research institute.[1]
These blood tests identify brain biological changes associated with Alzheimer's disease by detecting specific biomarkers, such as phosphorylated tau protein 217 (pTau217) and pTau181, without requiring invasive brain imaging or lumbar puncture procedures.[1] Phosphorylated tau217 has demonstrated significant diagnostic accuracy compared to brain imaging.[1] However, the tests cannot independently diagnose the disease and must be used in combination with clinical symptoms, cognitive testing, and other examinations.[1] Currently, these tests are not covered by Medicare, requiring patients to pay out of pocket.[1]
The blood tests are recommended for patients who already have persistent cognitive symptoms or mild cognitive impairment, but are not recommended for routine screening in asymptomatic healthy adults.[1] Researchers note that Alzheimer's brain changes may begin developing years before symptoms appear.[1]
