phosphoTAU ELISA

CE-IVD certified

 

Enzyme immunoassay for quantitative determination of Phospho-Tau in human CSF

 

3.5 h protocol, 25 µl CSF required

Intended use

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:

  • a preclinical stage of Alzheimer’s Disease,
  • the mild cognitive impairment (MCI) stage due to AD and
  • dementia stage due to AD.

Phosphorylated tau in CSF shows at least comparable diagnostic specificity and sensitivity to other diagnostic available tests for Alzheimer’s disease.

Status

CE-IvD

Specifications

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 %

 

Order information

Item number

  

Kit size

847-0108000104

  

96 reactions

Downloads

Available soon.