Clinical cutoff value was established using samples
from a patient cohort characterized with
amyloid PET data.
A p-tau217 value of >0.18 is a reported surrogate marker
for beta amyloid pathology, and can be used to
facilitate biological identification
of Alzheimer's disease.
P-tau217 has also been used in
clinical trials to monitor
patients on anti-amyloid therapy.
This test is performed by Fujirebio Lumipulse
chemiluminescent enzyme immunoassay (CLEIA).
Values obtained with different methods
cannot be used interchangeably.
The validated limit of quantification is 0.06 pg/mL.
Assay detection limit is 0.03 pg/mL.