CE-IVD certified
Enzyme immunoassay for quantitative determination of Phospho-Tau in human CSF
3.5 h protocol, 25 µl CSF required
The phosphoTAU ELISA is an enzyme immunoassay intended for the quantitative determination of phosphorylated tau in human cerebrospinal fluid (CSF) for supporting diagnosis of Alzheimer’s disease (AD). The development of Alzheimer’s disease is characterized by three stages, as defined by the US National Institute on Aging workgroups:
Phosphorylated tau in CSF shows at least comparable diagnostic specificity and sensitivity to other diagnostic available tests for Alzheimer’s disease.
CE-IvD
Cut-Off | 51 pg/ml | each laboratory must establish its own Cut-Off values |
Analytical Sensitivity | 15 pg/ml | Mean signal negative control (blank) + 3xSD |
Clinical Sensitivity | 87 % | AD/MCI patients (n=64) |
Clinical Specifity | 92 % | Controls (n=37) |
Area under ROC-curve (AUC) | 97.1 % |
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Item number | Kit size | ||
847-0108000104 | 96 reactions |