For in vitro diagnostic use. Others Elecsys beta-Amyloid 1-42 CSF II IVD Elecsys® β-Amyloid (1-42) CSF II PID00000063 08 821 909 190 8 821 909 190 08821909190 8821909190 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 08 821 941 190 8 821 941 190 08821941190 8821941190 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 08821909500 Elecsys β-Amyloid (1-42) CSF II en 1 FF000000049ED10E 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 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

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