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Elecsys® Total -Tau CSF

ElectroChemiLuminescence Immunoassay (ECLIA) for the in vitro quantitative determination of total Tau in human Cerebrospinal Fluid (CSF)

Tau (tubulin-associated unit) protein is one of the two hallmarks of Alzheimer’s disease, besides β-Amyloid (1-42)(Abeta42). The Elecsys Total-Tau CSF assay is designed to detect the six human brain Tau isoforms or fragments in human CSF.

Many studies show that total Tau CSF (tTau) levels increase around 2 – 3 fold in mild moderate Alzheimer’s Disease patients compared to age matched controls while CSF β Amyloid (1 42) levels decrease to around half the level in controls.1,2 CSF tTau has been shown to reflect the intensity of the neuronal and axonal damage and degeneration. High CSF tTau is also associated with a faster progression from Mild Cognitive Impairment (MCI) to AD.3

Elecsys® Total-Tau CSF (tTau) is an in vitro diagnostic immunoassay intended for the quantitative determination of the total tau protein concentration in human cerebrospinal fluid (CSF).4

Elecsys® tTau assay is part of the Elecsys® AD portfolio, along with Elecsys® β-Amyloid(1-42) CSF II (AB42 2)  and Elecsys® Phospho-Tau (181P) CSF (pTau) immunoassays.4

Elecsys® AD CSF assays can detect amyloid positivity, enhancing diagnostic accuracy and physician confidence.5,6

Elecsys® AD CSF assays enable timely intervention by identifying patients with MCI at risk of progression to AD.4,6

Elecsys® Total -Tau CSF

  1. Mattsson, N., Zetterberg, H., Hansson, O. et al. (2009). JAMA 22, 302(4), 385-93.
  2. Hampel, H., Blennow, K. (2004). Dialogues Clin Neurosci, 6(4), 379-390. 
  3. Blom, ES., Giedraitis, V., Zetterberg, H. et al. (2009). Dement Geriatr Cogn Disord, 27(5), 458-64.
  4. Elecsys® Method Sheet: ms_08821941500V1.0, ms_08821909500V1.0, ms_08846715500V1.0, ms_08846693500V1.0,  ms_08846634500V1.0, ms_08846685500V1.0
  5. Rabinovici, G.D. et al. (2019). Association of Amyloid Positron Emission Tomography With Subsequent Change in Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia. JAMA 321(13), 1286-1294.
  6. 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

Elecsys® Total -Tau CSF

  • 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

    50 μL

  • 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)