期刊
NEUROLOGY
卷 95, 期 22, 页码 E3026-E3035出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0000000000010814
关键词
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资金
- MH CZ-DRO, Motol University Hospital, Prague, Czech Republic [00064203]
- Institutional Support of Excellence 2, LF UK [699012]
- Ministry of Health of the Czech Republic [19-04-00560]
- Swedish Research Council [2018-02532, 2017-00915]
- European Research Council [681712]
- UK Dementia Research Institute at UCL
- Swedish government [ALFGBG-720931, ALFGBG-715986]
- County Councils, the ALF agreement [ALFGBG-720931, ALFGBG-715986]
- Swedish Alzheimer Foundation [AF-742881]
- Hjarnfonden, Sweden [FO2017-0243]
- European Commission (Marie Curie International Training Network, JPND)
- Health Holland
- Dutch Research Council (ZonMW)
- Weston Brain Institute
- Alzheimer Netherlands
Objective To investigate whether tau phosphorylated at Thr217 (p-tau T217) assay in CSF can distinguish patients with Alzheimer disease (AD) from patients with other dementias and healthy controls. Methods We developed and validated a novel Simoa immunoassay to detect p-tau T217 in CSF. There was a total of 190 participants from 3 cohorts with AD (n = 77) and other neurodegenerative diseases (n = 69) as well as healthy participants (n = 44). Results The p-tau T217 assay (cutoff 242 pg/mL) identified patients with AD with accuracy of 90%, with 78% positive predictive value (PPV), 97% negative predictive value (NPV), 93% sensitivity, and 88% specificity, compared favorably with p-tau T181 ELISA (52 pg/mL), showing 78% accuracy, 58% PPV, 98% NPV, 71% specificity, and 97% sensitivity. The assay distinguished patients with AD from age-matched healthy controls (cutoff 163 pg/mL, 98% sensitivity, 93% specificity), similarly to p-tau T181 ELISA (cutoff 60 pg/mL, 96% sensitivity, 86% specificity). In patients with AD, we found a strong correlation between p-tau T217 and p-tau T181, total tau and beta-amyloid 40, but not beta-amyloid 42. Conclusions This study demonstrates that p-tau T217 displayed better diagnostic accuracy than p-tau T181. The data suggest that the new p-tau T217 assay has potential as an AD diagnostic test in clinical evaluation. Classification of evidence This study provides Class III evidence that a CSF immunoassay for p-tau T217 distinguishes patients with AD from patients with other dementias and healthy controls.
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