For in vitro diagnostic use. Others Elecsys Phospho-Tau 181P CSF IVD Elecsys® Phospho-Tau (181P) CSF CPS_000504 07357036190 pTau Elecsys cobas e 60 Elecsys Phospho-Tau (181P) CSF 07613336149867 Reagents, kits 60 tests cobas e 411/601/602 true 08846693160 pTau Elecsys cobas e 60 V2 pTau Elecsys cobas e 60 V2 07613336208366 Reagents, kits 60 tests cobas e 411/601/602 undefined 07357036161 pTau Elecsys cobas e 60 RUO Elecsys pTau (181P) CSF RUO 07613336159118 Reagents, kits 60 tests cobas e 601 true 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 07357036500 Elecsys Phospho-Tau (181P) CSF en 4 FF0000000507280E FF000000022A250E 07357036190 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 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 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 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 Elecsys and cobas e immunoassay analyzers. en ms_07357036190 Elecsys Phospho-Tau (181P) CSF en 1 FF000000022A250E FF000000021F230E 07357036190 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 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 assay as a ratio in adult subjects with cognitive impairment being evaluated for AD and other causes of cognitive impairment. 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 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 Elecsys and cobas e immunoassay analyzers. en 08846693501 Elecsys Phospho-Tau (181P) CSF en 2 FF00000005DDF40E FF00000005DD0D0E 08846693160 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 useElecsys β-Amyloid (1-42) CSF II and Elecsys Phospho‑Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β‑Amyloid (1‑42) (Abeta42) and Phospho‑Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value. A negative result, defined as pTau181/Abeta42 ratio value below cutoff or an Abeta42 value above the measuring range, is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive result, defined as pTau181/Abeta42 ratio value above cut‑off, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The pTau181/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of useThe performance of the pTau181/Abeta42 ratio has not been established for:Predicting development of dementia or other neurologic conditionsMonitoring responses to therapies en ms_07357036161_USA Elecsys pTau (181P) CSF RUO en 1 FF0000000274DF0E FF0000000274DF0E 07357036161 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. 08846693500 Elecsys Phospho-Tau (181P) CSF en 2 FF000000065AEA0E 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 2 FF0000000663360E 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 08846715501 Elecsys Phospho-Tau (181P) CSF en 2 FF0000000626360E FF00000005DDD90E 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 useElecsys β-Amyloid (1-42) CSF II and Elecsys Phospho‑Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β‑Amyloid (1‑42) (Abeta42) and Phospho‑Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value. A negative result, defined as pTau181/Abeta42 ratio value below cutoff or an Abeta42 value above the measuring range, is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive result, defined as pTau181/Abeta42 ratio value above cut‑off, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The pTau181/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of useThe performance of the pTau181/Abeta42 ratio has not been established for:Predicting development of dementia or other neurologic conditionsMonitoring responses to therapies en