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% |
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Order information
Item number | Kit size | ||
847-0108000102 | 96 reactions |