hTAU total ELISA CE-IVD
hTAU Total Elisa
Product description
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
- 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 Info
| Code | Description | Format |
| 847-0108000101 | hTAU Total ELISA | 96 rxns |
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