non-pTAU ELISA

CE-IVD certified

 

Enzyme immunoassay for quantitative determination of a non-phosphorylated TAU fraction in human CSF supporting the diagnosis of Alzheimer’s disease

 

3.5 h protocol, 50 µl CSF required

Intended use

The non-pTAU ELISA is an enzyme immunoassay intended for the quantitative determination of a tau fraction without (w/o) phosphor at T175/T181 in human CSF for supporting diagnosis of Alzheimer’s disease. 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 w/o phosphor T175/T181 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

78 pg/ml

each laboratory must establish its own Cut-Off values

Analytical Sensitivity

12 pg/ml

Mean signal negative control (blank) + 3xSD

Clinical Sensitivity

95%

AD/MCI patients (n=58)

Clinical Specifity

98%

Controls (n=42)

Area under ROC-curve (AUC)

97.4%

 

Order information

Item number

  

Kit size

847-0108000102

  

96 reactions

Downloads

Available soon.