For in vitro diagnostic use. Others Elecsys beta-Amyloid 1-42 CSF II IVD Elecsys® β-Amyloid (1-42) CSF II PID00000063 08821909190 beta-Amyloid(1-42) G2 Elecsys cobas e60 Elecsys beta-Amyloid (1-42) CSF 07613336166314 Reagents, kits 60 tests cobas e 411/601/602 true 08821941190 beta-Amyloid(1-42) G2 Elecsys E2G 100 Elecsys beta-Amyloid (1-42) CSF II 07613336166321 Reagents, kits 100 tests cobas e 402/801 true 08821909160 beta-Amyloid(1-42) G2 Elecsys cobas e 60 beta-Amyloid(1-42) G2 Elecsys cobas e 60 07613336208359 Reagents, kits 60 tests cobas e 411/601/602 true 08821909500 Elecsys β-Amyloid (1-42) CSF II en 2 FF0000000663460E FF000000049ED10E 08821909190 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 is an in vitro diagnostic immunoassay intended for the quantitative determination of the β‑amyloid (1‑42) protein concentration in human cerebrospinal fluid (CSF). The Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used in adult subjects with cognitive impairment being evaluated for Alzheimer disease (AD) and other causes of cognitive impairment. Result above the cutoff is consistent with a negative amyloid positron emission tomography (PET) scan. Negative β‑amyloid PET scans indicate sparse to no neuritic plaques and are inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. The Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used in combination with Elecsys Phospho‑Tau (181P) CSF or Elecsys Total‑Tau 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 are concordant with positive and negative amyloid Positron Emission Tomography (PET) scan result, respectively. Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used alone or in combination with Elecsys Phospho-Tau (181P) CSF or Elecsys Total‑Tau 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.Limitations of useElecsys β‑Amyloid (1‑42) CSF II assay is an adjunct to other clinical diagnostic evaluations. A positive Elecsys β‑Amyloid (1‑42) CSF II assay result and/or a positive Elecsys Phospho-Tau (181P) CSF or 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 β‑Amyloid (1‑42) CSF II assay have not been established for monitoring responses to therapies. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en 08821941501 Elecsys β-Amyloid (1-42) CSF II en 4 FF000000065EF10E FF00000005DDD80E 08821941190 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 use #2: tTau/Abeta42 ratio for amyloid PET concordanceElecsys 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 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 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 08821941501 Elecsys β-Amyloid (1-42) CSF II en 1 FF00000005DDD80E FF00000005DD140E 08821941190 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 08821941500 Elecsys β-Amyloid (1-42) CSF II en 1 FF000000049ED20E FF000000049ED20E 08821941190 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 is an in vitro diagnostic immunoassay intended for the quantitative determination of the β‑amyloid (1‑42) protein concentration in human cerebrospinal fluid (CSF). The Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used in adult subjects with cognitive impairment being evaluated for Alzheimer disease (AD) and other causes of cognitive impairment. Result above the cutoff is consistent with a negative amyloid positron emission tomography (PET) scan. Negative β‑amyloid PET scans indicate sparse to no neuritic plaques and are inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. The Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used in combination with Elecsys Phospho‑Tau (181P) CSF or Elecsys Total‑Tau 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 are concordant with positive and negative amyloid Positron Emission Tomography (PET) scan result, respectively. Elecsys β‑Amyloid (1‑42) CSF II assay is intended to be used alone or in combination with Elecsys Phospho-Tau (181P) CSF or Elecsys Total‑Tau 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.Limitations of useElecsys β‑Amyloid (1‑42) CSF II assay is an adjunct to other clinical diagnostic evaluations. A positive Elecsys β‑Amyloid (1‑42) CSF II assay result and/or a positive Elecsys Phospho-Tau (181P) CSF or 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 β‑Amyloid (1‑42) CSF II assay have not been established for monitoring responses to therapies. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers. en 08821909501 Elecsys β-Amyloid (1-42) CSF II en 1 FF00000005DD1D0E FF00000005DD0A0E 08821909160 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 08821909501 Elecsys β-Amyloid (1-42) CSF II en 3 FF000000065EEB0E FF00000005DD1D0E 08821909160 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 use #2: tTau/Abeta42 ratio for amyloid PET concordanceElecsys 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 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 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