hTAU total ELISA

CE-IVD labeled

 

Enzyme immunoassay for quantitative determination of human TAU in human CSF supporting the diagnosis of Alzheimer’s disease

 

4 h protocol, 25 µl CSF required

Intended use

The hTAU total ELISA is an enzyme immunoassay intended for the quantitative determination of total tau protein in human CSF for supporting diagnosis of Alzheimer’s disease (AD). The development of the 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.

Tau shows at least comparable diagnostic specificity and sensitivity to other diagnostic available tests for Alzheimer’s disease

Status

CE-IvD

Specifications

Cut-Off

399 pg/ml

each laboratory must establish its own Cut-Off values

Analytical Sensitivity

25 pg/ml

Mean signal negative control (blank) + 3xSD

Clinical Sensitivity

86%

AD/MCI patients (n=72)

Clinical Specifity

98%

Controls (n=41)

Area under ROC-curve (AUC)

96.6%

 

Order information

Item number

  

Kit size

847-0108000101

  

96 reactions

Downloads

Available soon.