phosphoTAU total ELISA CE-IVD
phosphoTAU Total Elisa
Product description
phosphoTAU total ELISA is an enzyme immunoassay intended for the quantitative determination of phosphorylated tau in human cerebrospinal fluid (CSF) for supporting diagnosis of Alzheimer’s disease (AD). The development of 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 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 | 51 pg/ml | each laboratory must establish its own Cut-Off values |
| Analytical Sensitivity | 15 pg/ml | Mean signal negative control (blank) + 3xSD |
| Clinical Sensitivity | 87% | AD/MCI patients (n=64) |
| Clinical Specifity | 92% | Controls (n=37) |
| Area under ROC-curve (AUC) | 97.1% |
Order Info
| Code | Description | Format |
| 847-0108000104 | phoshoTAU Total ELISA | 96 rxns |
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