For in vitro diagnostic use. Others Elecsys Total-Tau CSF IVD Elecsys® Total-Tau CSF CPS_000534 07356994161 tTau Elecsys cobas e 60 RUO Elecsys Total-Tau CSF RUO 07613336159149 Reagents, kits 60 tests cobas e 601 true 08846634190 tTau Elecsys cobas e60 V2 Elecsys Total-Tau CSF 07613336167632 Reagents, kits 60 tests cobas e 411/601/602 true 07356994190 tTau Elecsys cobas e 60 Elecsys Total-Tau CSF 07613336149898 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 08846634160 tTau Elecsys cobas e60 V2 Elecsys Total-Tau CSF 07613336221761 Reagents, kits 60 tests cobas e 411/601/602 true ms_07356994161_USA Elecsys Total-Tau CSF RUO en 1 FF00000002603D0E FF00000002603D0E 07356994161 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. 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 07356994500 Elecsys Total-Tau CSF en 4 FF0000000548BE0E FF000000022A840E 07356994190 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 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 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 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 Elecsys and cobas e immunoassay analyzers. en ms_07356994190 Elecsys Total-Tau CSF en 1 FF000000022A840E FF000000021B010E 07356994190 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 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 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 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 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 Elecsys and cobas e immunoassay analyzers. en 08846685501 Elecsys Total-Tau CSF en 3 FF00000006A9140E FF0000000648BA0E 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 useElecsys β‑Amyloid (1‑42) CSF II and Elecsys Total‑Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β‑Amyloid (1‑42) (Abeta42) and Total‑Tau (tTau) protein concentration 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 tTau/Abeta42 ratio value. A negative result, defined as tTau/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 tTau/Abeta42 ratio value above cutoff, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of useThe performance of the tTau/Abeta42 ratio has not been established for:Predicting development of dementia or other neurologic conditionsMonitoring responses to therapies en 08846685500 Elecsys Total-Tau CSF en 2 FF000000065B370E FF000000049EE00E 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 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 08846634501 Elecsys Total-Tau CSF en 2 FF0000000656A60E FF000000064F2B0E 08846634160 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 Total‑Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the β‑Amyloid (1‑42) (Abeta42) and Total‑Tau (tTau) protein concentration 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 tTau/Abeta42 ratio value. A negative result, defined as tTau/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 tTau/Abeta42 ratio value above cutoff, is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of useThe performance of the tTau/Abeta42 ratio has not been established for:Predicting development of dementia or other neurologic conditionsMonitoring responses to therapies en