Elecsys® Total-Tau CSF

Robust and accurate biomarker tests to aid clinical decisions
IVD For in vitro diagnostic use.
Elecsys Total -Tau CSF
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Elecsys® Total -Tau CSF specifications

  • Systems

    cobas e 411 analyzer, cobas e 601 / cobas e 602 modules, MODULAR ANALYTICS E170

  • Testing Time

    18 minutes

  • Test principle

    Sandwich principle

  • Calibration

    2-point

  • Traceability

    LC-MS/MSTau (172-205) [pThr181]amidTau (156-166) – Tau (192-202) – Tau (217-227) amid

  • Sample material

    Human Cerebrospinal Fluid (CSF)

  • Sample volume

    30 µL - cobas e 801 module and cobas e 402 module 

    50 µL - cobas e 411 analyzer and cobas e 601/602 modules

     

     

     

     

     

     

     

  • LoB (Limit of Blank)

    30 pg/mL

  • LoD (Limit of Detection)

    60 pg/mL

  • LoQ (Limit of Quantitation)

    80 pg/mL

  • Measuring range

    8-1,300 pg/mL (defined by the Limit of Quantitation and the maximum of the master curve)

    Values below the Limit of Quantitation are reported as < 80 pg/mL

    Values above the measuring range are reported as > 1,300 pg/mL

  • Intermediate precision

    cobas e 411: 2.2-3.5% (4.14 - 40.3 pg/mL)
    E170, cobas e 601, cobas e 602: 1.4% -2.1% (1.63 – 19.5 pg/mL)

References

  1. Total-Tau (tTau) CSF method sheet 2023-04.
  2. Mattsson N, Zetterberg H, Hansson O, et al. CSF biomarkers and incipient Alzheimer disease in patients with mild cognitive impairment. JAMA. 2009;302(4):385-393. 
  3. Hampel H, Blennow K. CSF tau and β-amyloid as biomarkers for mild cognitive impairment. Dialogues Clin Neurosci. 2004;6(4):379-90.
  4. Sabbagh MN, Lue LF, Fayard D, Shi J. Increasing Precision of Clinical Diagnosis of Alzheimer's Disease Using a Combined Algorithm Incorporating Clinical and Novel Biomarker Data. Neurol Ther. 2017;6(Suppl 1):83-95.
  5. Hansson, O. et al. (2018). CSF biomarkers of Alzheimer’s disease concord with amyloid-β PET and predict clinical progression: A study of fully automated immunoassays in BioFINDER and ADNI cohorts. Alzheimers Dement 14(11), 1470-1481.

Overview

Detailed Specifications

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