Elecsys® β-Amyloid (1-40) CSF

IVD For in vitro diagnostic use.

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Powering Alzheimer’s disease clarity

Alzheimer's disease (AD) is the most common cause of dementia, a progressive neurodegenerative disorder that severely impacts memory and cognition.1 In 2021, an estimated 57 million people worldwide were living with dementia, projecting a massive rise that creates a significant global healthcare and economic burden.1 As the seventh leading cause of death globally, the substantial costs of caregiving strain both health systems and families.1

Epidemiology and healthcare burden

AD is characterized by the accumulation of ß-amyloid (Aβ) plaques and tau protein tangles in the brain. Early symptoms are often nonspecific and overlap with other conditions, making a timely and accurate differential diagnosis challenging.1 Given the sheer number of affected individuals and the intensive long-term care required, AD represents one of the most pressing public health challenges worldwide.

An illustration of two people on a mountain pathway shared a journey to achieve a neurological diagnosis

Pinpointing amyloid pathology

For effective patient management and access to new disease-modifying therapies, a definitive diagnosis is crucial. This is achieved by measuring specific cerebrospinal fluid (CSF) biomarkers: Aβ42, total Tau (t-Tau), and phosphorylated Tau (p-Tau).2

Clarity with single cut-offs: The power of ratios

Relying on single Aβ42 concentrations can be problematic due to analytical and pre-analytical variability (3). Ratio biomarkers, however, significantly improve diagnostic accuracy and concordance with positron emission tomography (PET) imaging.3,4 Assays that utilize single, validated cut-offs for ratios offer superior clarity and confidence in confirming amyloid pathology.
 

  • Aβ42/Aβ40 Ratio: This ratio is superior to Aβ42 alone for detecting brain amyloid deposition, even in the prodromal stage of AD, and for differentiating AD from other dementias.3,4
  • pTau/Aβ42 and tTau/Aβ42 Ratios: Normalizing Tau markers to Aβ42 equally enhances diagnostic performance. These ratios provide a reliable method to confirm both core pathological changes, showing slightly stronger concordance with amyloid PET.5

Accurate, reliable CSF assay results, powered by these ratios and a single cut-off, give clinicians the definitive diagnosis with confidence needed for optimized patient care and clinical trial recruitment.4

This is the power of clarity, built on a foundation of trust.

Benefits at a glance

Benefits at a glance

Seamless integration into the AD CSF portfolio with a single clinically validated cutoff and balanced sensitivity and specificity
  • Same standardized process 
  • Clarity with the amyloid protein ratio 
Signpost with multiple arrows and a checkmark showing confident decision-making with the Elecsys B-Amyloid (1-40) CSF product
  • Single-cut off based on clinically validated data
  • Optimized balance between sensitivity and specificity 
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  • Maximizes flexibility in the choice of the best fitting ratio together with Aβ42, pTau, and tTau
  • Conforms with guideline recommendations 

Product specifications

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Product specifications

Product specification

Value

Systems

cobas® e 402 analytical unit, cobas® e 801 analytical unit


Testing time

18 minutes

Sample material

Cerebrospinal fluid (CSF)

Sample volume

12 µL

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References

  1. World Health Organization (WHO). Dementia: Key facts [Internet; cited 2025 Nov 24] . Available from: https://www.who.int/news-room/fact-sheets/detail/dementia
  2. Hansson et al. The Use of beta-Amyloid-Related Cerebrospinal Fluid Biomarkers to Predict Conversion to Alzheimer’s Disease in Patients with Mild Cognitive Impairment: A Meta-Analysis. Journal of Alzheimer's Disease. 2018;65(3).
  3. Lewczuk P, et al. Cerebrospinal fluid Abeta42/Abeta40 corresponds better than Abeta42 to amyloid PET in Alzheimer’s disease. Journal of Alzheimer's Disease.  2017;55(2):813-822.
  4. Gabelle A, et al. Relevance of Abeta42/Abeta40 Ratio for Detection of Alzheimer Disease Pathology in Clinical Routine: The PLMR Scale. Frontiers in Aging Neuroscience. 2018;10:138. 
  5. Parnetti et al. Additional Use of Abeta42/Abeta40 Ratio with Cerebrospinal Fluid Biomarkers P-Tau and Abeta42 Increases the Level of Evidence of Alzheimer's Disease Pathophysiological Process in Routine Practice. Journal of Alzheimer's Disease. 2014;41(2). 
  6. F.  Hoffmann-La Roche Ltd. AB40 CSF Method sheet.