Evaluation Of A Novel Immunoassay To Detect P-tau THR127 In The CSF To Distinguish Alzheimer Disease From Other Dementias.
Hanes J, Kovac A, Kvartsberg H, Kontsekova E, Fialova L, Katina S, Kovacech B, Stevens E, Hort J, Vyhnalek M, Boonkamp L, Novak M, Zetterberg H, Hansson O, Scheltens P, Blennow K, Teunissen CE and Zilka N.
Neurology. 2020 Sep 24;10.1212/WNL.0000000000010814
To investigate whether p-tau T217 assay in cerebrospinal fluid (CSF) can distinguish Alzheimer’s disease from other dementias and healthy controls.
We developed and validated a novel Simoa immunoassay to detect p-tau T217 in CSF. There was a total of 190 participants from three cohorts with AD (n = 77) and other neurodegenerative diseases (n = 69) as well as healthy subjects (n = 44).
The p-tau T217 assay (cut-off 242 pg/ml) identified AD subjects with accuracy of 90%, with 78% positive predictive value (PPV), 97% negative predictive value (NPV), 93% sensitivity, 88% specificity compared favorably with p-tau T181 ELISA (52 pg/ml) showing 78% accuracy, 58% PPV, 98% NPV, 71% specificity, 97% sensitivity. The assay distinguished AD patients from age-matched healthy subjects (cut-off 163 pg/ml, sensitivity 98%, specificity 93%) similarly to p-tau T181 ELISA (cut-off 60 pg/ml, 96% sensitivity and 86% specificity). In AD patients, we found a strong correlation between p-tau T217-tau and p-tau T181, t-tau and Aβ40 but not with Aβ42.
This study demonstrates that p-tau T217 displayed better diagnostic accuracy than p-tau T181. The data suggests that the new p-tau T217 assay has a potential as an AD diagnostic test in the clinical evaluation.
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