Testing and interpretation supported
by clinical research

Our testing is validated and developed through the use of in-house clinical studies. We also reference publications and research in each of our reports to provide clinical evidence to our interpretations.

Publications

• Association of Amyloid Positron Emission Tomography With Subsequent Change in Clinical Management Among Medicare Beneficiaries With Mild Cognitive Impairment or Dementia
  Amyloid positron emission tomography (PET) detects amyloid plaques in the brain, a core neuropathological feature of Alzheimer disease

• Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements
  The cerebrospinal fluid (CSF) amyloid-β (Aβ42) peptide is an important biomarker for Alzheimer's disease (AD). Variability in measured Aβ42 concentrations at different laboratories may be overcome by standardization and establishing traceability to a reference system. Candidate certified reference materials (CRMs) are validated herein for this purpose.

• Cerebrospinal fluid biomarkers measured by Elecsys assays compared to amyloid imaging
  Levels of amyloid β peptide 42 (Aβ42), total tau, and phosphorylated tau-181 are well-established cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease, but variability in manual plate-based assays has limited their use. We examined the relationship between CSF biomarkers, as measured by a novel automated immunoassay platform, and amyloid positron emission tomography.

• Effect of sample collection tubes on cerebrospinal fluid concentrations of tau proteins and amyloid beta peptides
  

• How early can we diagnose Alzheimer disease (and is it sufficient)?
  A seismic shift in our understanding of the ability to diagnose Alzheimer disease (AD) is occurring. For the last several decades, AD has been a clinical-pathologic diagnosis, and this conceptualization of the disease has served the field well. 

• How to handle adsorption of cerebrospinal fluid amyloid β (1-42) in laboratory practice? Identifying problematic handlings and resolving the issue by use of the Aβ ₄₂/Aβ ₄₀ ratio
  This study aimed to investigate factors defining amyloid β (1-42) (Aβ_1-42) adsorption during preanalytical workup of cerebrospinal fluid (CSF).

• NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease
  In 2011, the National Institute on Aging and Alzheimer's Association created separate diagnostic recommendations for the preclinical, mild cognitive impairment, and dementia stages of Alzheimer's disease. Scientific progress in the interim led to an initiative by the National Institute on Aging and Alzheimer's Association to update and unify the 2011 guidelines. 

• Optimized Standard Operating Procedures for the Analysis of Cerebrospinal Fluid Aβ₄₂ and the Ratios of Aβ Isoforms Using Low Protein Binding Tubes
  Reduced cerebrospinal fluid (CSF) concentration of amyloid-β_1-42 (Aβ_1-42) reflects the presence of amyloidopathy in brains of subjects with Alzheimer’s disease (AD).

• The impact of preanalytical variables on measuring cerebrospinal fluid biomarkers for Alzheimer's disease diagnosis: A review
  Cerebrospinal fluid (CSF) biomarkers have the potential to improve the diagnostic accuracy of Alzheimer's disease, yet there is a lack of harmonized preanalytical CSF handling protocols.