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% |
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Order information
Item number | Kit size | ||
847-0108000101 | 96 reactions |