For in vitro diagnostic use. Others Elecsys Phospho-Tau 181P CSF IVD Elecsys® Phospho-Tau (181P) CSF CPS_000504 08846693190 pTau Elecsys cobas e60 V2 Elecsys Phospho-Tau (181P) CSF 07613336167656 Reagents, kits 60 tests cobas e 411/601/602 true 08846715190 pTau Elecsys E2G 100 V2 Elecsys Phospho-Tau (181P) CSF 07613336167663 Reagents, kits 100 tests cobas e 402/801 true 08846693500 Elecsys Phospho-Tau (181P) CSF en 1 FF000000049EDB0E FF000000049EDB0E 08846693190 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 Phospho-Tau (181P) CSF assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the phosphorylated Tau protein in human CSF. The Elecsys Phospho‑Tau (181P) 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 Phospho‑Tau (181P) 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 Phospho‑Tau (181P) CSF assay is an adjunct to other clinical diagnostic evaluations.A positive Elecsys Phospho‑Tau (181P) CSF assay result and/or a positive Elecsys Phospho‑Tau (181P) 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 Phospho‑Tau (181P) 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 08846715500 Elecsys Phospho-Tau (181P) CSF en 1 FF000000049EDC0E FF000000049EDC0E 08846715190 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 Phospho-Tau (181P) CSF assay is an in vitro diagnostic immunoassay intended for the quantitative determination of the phosphorylated Tau protein in human CSF. The Elecsys Phospho‑Tau (181P) 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 Phospho‑Tau (181P) 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 Phospho‑Tau (181P) CSF assay is an adjunct to other clinical diagnostic evaluations.A positive Elecsys Phospho‑Tau (181P) CSF assay result and/or a positive Elecsys Phospho‑Tau (181P) 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 Phospho‑Tau (181P) 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