CSF biomarkers of Alzheimer's disease concord with amyloid‐β PET and predict clinical progression: A study of fully automated immunoassays in BioFINDER and ADNI cohorts
Open accessAbstract
Introduction: We studied whether fully automated Elecsys cerebrospinal fluid (CSF) immunoassay results were concordant with positron emission tomography (PET) and predicted clinical progression, even with cutoffs established in an independent cohort. Methods: Cutoffs for Elecsys amyloid‐β 1–42 (Aβ), total tau/Aβ(1–42), and phosphorylated tau/Aβ(1–42) were defined against [18 F]flutemetamol PET in Swedish BioFINDER (n = 277) and validated against [18 F]florbetapir PET in Alzheimer's Disease Neuroimaging Initiative (n = 646). Clinical progression in patients with mild cognitive impairment (n = 619) was studied. Results: CSF total tau/Aβ(1–42) and phosphorylated tau/Aβ(1–42) ratios were highly concordant with PET classification in BioFINDER (overall percent agreement: 90%; area under the curve: 94%). The CSF biomarker statuses established by predefined cutoffs were highly concordant with PET classification in Alzheimer's Disease Neuroimaging Initiative (overall percent agreement: 89%–90%; area under the curves: 96%) and predicted greater 2‐year clinical decline in patients with mild cognitive impairment. Strikingly, tau/Aβ ratios were as accurate as semiquantitative PET image assessment in predicting visual read–based outcomes. Discussion: Elecsys CSF biomarker assays may provide reliable alternatives to PET in Alzheimer's disease diagnosis.
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In previous studies, the FDA-approved Elecsys CSF p-tau181/Aβ42 test classified Aβ PET status with overall accuracies of 89-90%.
“For instance, the FDA-approved Elecsys CSF p-tau181/Aβ42 test has, in previous studies, classified Aβ PET status with overall accuracies of 89–90% (refs. 39–41), which was replicated in the present study.”
From Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests (2024) · cites this paper as [39]
The Results (§4.1) report 90% overall agreement with amyloid-β PET for the Elecsys CSF pTau/Aβ(1–42) ratio; the Discussion (§5) reports approximately 89–90% agreement across BioFINDER and ADNI. The Methods (§3.6) identify the pTau assay as phosphotau (181P), but our copy does not establish that the test was FDA-approved. (LLM, conf=0.87)
Experimental — accuracy not yet measuredExtracellular deposition of amyloid-β (Aβ) protein and aggregated hyperphosphorylated tau protein in the brain are two main pathological characteristics of Alzheimer's disease.
“An extracellular deposition of amyloid-β (Aβ) protein and aggregated form of hyper phosphorylated tau protein in the brain are two main pathological characteristics of AD [41].”
From Recent Advancements in Pathogenesis, Diagnostics and Treatment of Alzheimer’s Disease (2020) · cites this paper as [41]
For Elecsys immunoassays, CSF cutoffs established in one European cohort could be applied to another independent cohort in the United States to determine amyloid PET status with high accuracy.
“For example, for the Elecsys immunoassays (Roche Diagnostics), it has been shown that CSF cutoffs established in one European cohort could be applied to another independent cohort in the United States to determine amyloid PET status with high accuracy.24”
From Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status (2019) · cites this paper as [24]
Fully automated immunoassays have been developed by several different vendors with improved reliability and precision for CSF Aβ and tau species.
“Recently, fully automated immunoassays have been developed by several different vendors with improved reliability and precision for CSF Aβ and tau species.23,24,25”
From Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status (2019) · cites this paper as [24]
This robust result is similar to what has been shown when using the Elecsys assays for CSF to establish a cutoff in one cohort and replicating it in a second cohort.
“This robust result is similar to what has been shown when using the Elecsys assays for CSF to establish a cutoff in one cohort and replicating it in a second cohort.24”
From Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status (2019) · cites this paper as [24]
The contribution of plasma tau to plasma Aβ42/Aβ40 is clinically not comparable with the contribution of CSF tau combined with CSF Aβ42.
“Plasma tau increased the AUC slightly, and provided a better model fit (ΔAIC –27), but clinically this is not comparable with the contribution CSF tau has combined with CSF Aβ42,24 and improved plasma tau assays are probably needed in the future, such as measurement of specifically phosphorylated tau,46 to increase the added value of plasma tau to plasma Aβ42 and Aβ40.”
From Performance of Fully Automated Plasma Assays as Screening Tests for Alzheimer Disease–Related β-Amyloid Status (2019) · cites this paper as [24]
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“…individuals that have ever crossed one of the following thresholds have been considered as amyloid-positive individuals: CSF A β 1 – 42 = 880 pg/mL [47] or/and global PET florbetapir SUVr = 1.11, normalised to the whole cerebellum [48], or/and PiB-PET SUVr (standardised in the region relative to…”
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Self-citationP‐tau/Aβ42 and Aβ42/40 ratios in CSF are equally predictive of amyloid PET status
Campbell, M. R., Ashrafzadeh‐Kian, S., Petersen, R. C., Mielke, M. M., Syrjanen, J. A., van Harten, A. C., Lowe, V. J., Jack, C. R., Bornhorst, J. A., & Algeciras‐Schimnich, A. (2021) · Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring · doi:10.1002/dad2.12190 · Cited by 74 · see citing works
Asymmetric Dopamine Transporter Loss Affects Cognitive and Motor Progression in Parkinson's Disease
Fiorenzato, E., Antonini, A., Bisiacchi, P. S., Weis, L., & Biundo, R. (2021) · Movement Disorders · doi:10.1002/mds.28682 · Cited by 74 · see citing works
Mattke, S., Cho, S. K., Bittner, T., Hlávka, J. P., & Hanson, M. (2020) · Alzheimer s & Dementia Diagnosis Assessment & Disease Monitoring · doi:10.1002/dad2.12081 · Cited by 73 · see citing works
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- Authors
- Hansson, O., Seibyl, J., Stomrud, E., Zetterberg, H., Trojanowski, J. Q., Bittner, T., Lifke, V., Corradini, V., Eichenlaub, U., Batrla, R., Buck, K., Zink, K., Rabe, C., Blennow, K., Shaw, L. M., for the Swedish BioFINDER study group, & Initiative, A. D. N.
- Affiliations
- Lund University (SE)
- Institute for Neurodegenerative Disorders (US)
- Sahlgrenska University Hospital (SE)
- University of Pennsylvania (US)
- Former Employee of Roche Diagnostics GmbH Penzberg Germany
- Roche Diagnostics GmbH Penzberg Germany
- F. Hoffmann-La Roche AG (CH)
- Alzheimer’s Disease Neuroimaging Initiative (US)
- Corresponding author
- Hansson, Oskar
- Blennow, Kaj
- Shaw, Leslie M.
- ORCID
- Venue
- Alzheimer's & Dementia
- Publisher
- Wiley
- Published
- 2018-02-27
- Volume
- 14
- Issue
- 11
- Pages
- 1470-1481
- ISSN
- 1552-5260 (ISSN-L)
- 1552-5279
- PMC
- PMC6119541
- OpenAlex
- W2789976306
- Cited by
- 808
- References
- 45
- Citations by year
- 2026: 84 · 2025: 117 · 2024: 146 · 2023: 96 · 2022: 98 · 2021: 95 · 2020: 97 · 2019: 56 · 2018: 15 · 2015: 1
- FWCI
- 51.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Alzheimer s & Dementia (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion, cc-by-nc-nd)
- PubMed Central (acceptedVersion, cc-by-nc-nd)
- UCL Discovery (University College London) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Funders
- Michael J. Fox Foundation for Parkinson's Research
- Eli Lilly and Company
- Göteborgs Universitet
- National Institutes of Health
- National Institute on Aging (P30AG010124)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Cerebrospinal fluid and hydrocephalus
- Keywords
- Alzheimer's disease, cerebrospinal fluid biomarkers
- MeSH terms
- Aged, Alzheimer Disease, Aniline Compounds, Ethylene Glycols, Female, Humans, Immunoassay, Male, Cohort Studies, Biomarkers, Amyloid beta-Peptides, tau Proteins, Disease Progression, Radiopharmaceuticals, Positron-Emission Tomography, Automation, Laboratory, Cognitive Dysfunction
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
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