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Evaluation of a novel immunoassay to detect p-tau Thr217 in the CSF to distinguish Alzheimer disease from other dementias

Hanes, Jozef ; Kovac, Andrej ; Kvartsberg, Hlin ; Kontsekova, Eva ; Fialova, Lubica ; Katina, Stanislav ; Kovacech, Branislav ; Stevens, Eva ; Hort, Jakub and Vyhnalek, Martin , et al. (2020) In Neurology 95(22). p.3026-3035
Abstract

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%... (More)

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 β-amyloid 40, but not β-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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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Neurology
volume
95
issue
22
pages
3026 - 3035
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:32973122
  • scopus:85097004239
ISSN
1526-632X
DOI
10.1212/WNL.0000000000010814
language
English
LU publication?
yes
id
ead1c4ad-b4f5-4f38-8df0-94f6fb24a0c5
date added to LUP
2020-12-10 08:23:37
date last changed
2024-04-17 20:41:42
@article{ead1c4ad-b4f5-4f38-8df0-94f6fb24a0c5,
  abstract     = {{<p>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 β-amyloid 40, but not β-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.</p>}},
  author       = {{Hanes, Jozef and Kovac, Andrej and Kvartsberg, Hlin and Kontsekova, Eva and Fialova, Lubica and Katina, Stanislav and Kovacech, Branislav and Stevens, Eva and Hort, Jakub and Vyhnalek, Martin and Boonkamp, Lynn and Novak, Michal and Zetterberg, Henrik and Hansson, Oskar and Scheltens, Philip and Blennow, Kaj and Teunissen, Charlotte E. and Zilka, Norbert}},
  issn         = {{1526-632X}},
  language     = {{eng}},
  number       = {{22}},
  pages        = {{3026--3035}},
  publisher    = {{Lippincott Williams & Wilkins}},
  series       = {{Neurology}},
  title        = {{Evaluation of a novel immunoassay to detect p-tau Thr217 in the CSF to distinguish Alzheimer disease from other dementias}},
  url          = {{http://dx.doi.org/10.1212/WNL.0000000000010814}},
  doi          = {{10.1212/WNL.0000000000010814}},
  volume       = {{95}},
  year         = {{2020}},
}