For in vitro diagnostic use. Others Elecsys Total-Tau CSF IVD Elecsys® Total-Tau CSF CPS_000534 08846634190 tTau Elecsys cobas e60 V2 Elecsys Total-Tau CSF 07613336167632 Reagents, kits 60 tests cobas e 411/601/602 true 08846685190 tTau Elecsys E2G 100 V2 Elecsys Total-Tau CSF 07613336167649 Reagents, kits 100 tests cobas e 402/801 true 08846634500 Elecsys Total-Tau CSF en 2 FF000000065B380E FF000000049EDF0E 08846634190 618 cobas e 411 2325 cobas e 602 619 cobas e 601 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Elecsys Total‑Tau CSF assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the total Tau protein in human CSF. The Elecsys Total‑Tau CSF assay is intended to be used alone or in combination with Elecsys β‑Amyloid (1‑42) CSF II assay as a ratio in adult subjects with mild cognitive impairment (MCI) as an aid to identify subjects who are at lower vs. higher risk of cognitive decline as defined by change in a clinical score within a 2 year period.The Elecsys Total‑Tau CSF assay is intended to be used in combination with Elecsys β‑Amyloid (1‑42) CSF II assay as a ratio in adult subjects with cognitive impairment being evaluated for AD and other causes of cognitive impairment wherein a positive and negative CSF result is concordant with positive and negative amyloid Positron Emission Tomography (PET) scan result, respectively.Limitations of use The Elecsys Total‑Tau CSF assay is an adjunct to other clinical diagnostic evaluations.A positive Elecsys Total‑Tau CSF assay result and/or a positive Elecsys Total‑Tau CSF to Elecsys β‑Amyloid (1‑42) CSF II ratio result does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of the Elecsys Total‑Tau CSF assay have not been established for monitoring responses to therapies.The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en 08846685500 Elecsys Total-Tau CSF en 1 FF000000049EE00E FF000000048FBC0E 08846685190 2497 cobas e 801 9494 cobas e 402 Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative. Intended useThe Elecsys Total‑Tau CSF assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the total Tau protein in human CSF. The Elecsys Total‑Tau CSF assay is intended to be used alone or in combination with Elecsys β‑Amyloid (1‑42) CSF II assay as a ratio in adult subjects with mild cognitive impairment (MCI) as an aid to identify subjects who are at lower vs. higher risk of cognitive decline as defined by change in a clinical score within a 2 year period.The Elecsys Total‑Tau CSF assay is intended to be used in combination with Elecsys β‑Amyloid (1‑42) CSF II assay as a ratio in adult subjects with cognitive impairment being evaluated for AD and other causes of cognitive impairment wherein a positive and negative CSF result is concordant with positive and negative amyloid Positron Emission Tomography (PET) scan result, respectively.Limitations of use The Elecsys Total‑Tau CSF assay is an adjunct to other clinical diagnostic evaluations.A positive Elecsys Total‑Tau CSF assay result and/or a positive Elecsys Total‑Tau CSF to Elecsys β‑Amyloid (1‑42) CSF II ratio result does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of the Elecsys Total‑Tau CSF assay have not been established for monitoring responses to therapies.The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en