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Acceptable performance of blood biomarker tests of amyloid pathology — recommendations from the Global CEO Initiative on Alzheimer’s Disease

Schindler, Suzanne E. ; Galasko, Douglas ; Pereira, Ana C. ; Rabinovici, Gil D. ; Salloway, Stephen ; Suárez-Calvet, Marc ; Khachaturian, Ara S. ; Mielke, Michelle M. ; Udeh-Momoh, Chi and Weiss, Joan , et al. (2024) In Nature Reviews Neurology 20(7). p.426-439
Abstract

Anti-amyloid treatments for early symptomatic Alzheimer disease have recently become clinically available in some countries, which has greatly increased the need for biomarker confirmation of amyloid pathology. Blood biomarker (BBM) tests for amyloid pathology are more acceptable, accessible and scalable than amyloid PET or cerebrospinal fluid (CSF) tests, but have highly variable levels of performance. The Global CEO Initiative on Alzheimer’s Disease convened a BBM Workgroup to consider the minimum acceptable performance of BBM tests for clinical use. Amyloid PET status was identified as the reference standard. For use as a triaging test before subsequent confirmatory tests such as amyloid PET or CSF tests, the BBM Workgroup recommends... (More)

Anti-amyloid treatments for early symptomatic Alzheimer disease have recently become clinically available in some countries, which has greatly increased the need for biomarker confirmation of amyloid pathology. Blood biomarker (BBM) tests for amyloid pathology are more acceptable, accessible and scalable than amyloid PET or cerebrospinal fluid (CSF) tests, but have highly variable levels of performance. The Global CEO Initiative on Alzheimer’s Disease convened a BBM Workgroup to consider the minimum acceptable performance of BBM tests for clinical use. Amyloid PET status was identified as the reference standard. For use as a triaging test before subsequent confirmatory tests such as amyloid PET or CSF tests, the BBM Workgroup recommends that a BBM test has a sensitivity of ≥90% with a specificity of ≥85% in primary care and ≥75–85% in secondary care depending on the availability of follow-up testing. For use as a confirmatory test without follow-up tests, a BBM test should have performance equivalent to that of CSF tests — a sensitivity and specificity of ~90%. Importantly, the predictive values of all biomarker tests vary according to the pre-test probability of amyloid pathology and must be interpreted in the complete clinical context. Use of BBM tests that meet these performance standards could enable more people to receive an accurate and timely Alzheimer disease diagnosis and potentially benefit from new treatments.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Nature Reviews Neurology
volume
20
issue
7
pages
14 pages
publisher
Nature Publishing Group
external identifiers
  • scopus:85196113848
  • pmid:38866966
ISSN
1759-4758
DOI
10.1038/s41582-024-00977-5
language
English
LU publication?
yes
id
767948e9-1a8c-4cd8-b19f-bdd2d336fc04
date added to LUP
2024-09-09 15:56:21
date last changed
2024-12-17 04:29:05
@article{767948e9-1a8c-4cd8-b19f-bdd2d336fc04,
  abstract     = {{<p>Anti-amyloid treatments for early symptomatic Alzheimer disease have recently become clinically available in some countries, which has greatly increased the need for biomarker confirmation of amyloid pathology. Blood biomarker (BBM) tests for amyloid pathology are more acceptable, accessible and scalable than amyloid PET or cerebrospinal fluid (CSF) tests, but have highly variable levels of performance. The Global CEO Initiative on Alzheimer’s Disease convened a BBM Workgroup to consider the minimum acceptable performance of BBM tests for clinical use. Amyloid PET status was identified as the reference standard. For use as a triaging test before subsequent confirmatory tests such as amyloid PET or CSF tests, the BBM Workgroup recommends that a BBM test has a sensitivity of ≥90% with a specificity of ≥85% in primary care and ≥75–85% in secondary care depending on the availability of follow-up testing. For use as a confirmatory test without follow-up tests, a BBM test should have performance equivalent to that of CSF tests — a sensitivity and specificity of ~90%. Importantly, the predictive values of all biomarker tests vary according to the pre-test probability of amyloid pathology and must be interpreted in the complete clinical context. Use of BBM tests that meet these performance standards could enable more people to receive an accurate and timely Alzheimer disease diagnosis and potentially benefit from new treatments.</p>}},
  author       = {{Schindler, Suzanne E. and Galasko, Douglas and Pereira, Ana C. and Rabinovici, Gil D. and Salloway, Stephen and Suárez-Calvet, Marc and Khachaturian, Ara S. and Mielke, Michelle M. and Udeh-Momoh, Chi and Weiss, Joan and Batrla, Richard and Bozeat, Sasha and Dwyer, John R. and Holzapfel, Drew and Jones, Daryl Rhys and Murray, James F. and Partrick, Katherine A. and Scholler, Emily and Vradenburg, George and Young, Dylan and Algeciras-Schimnich, Alicia and Aubrecht, Jiri and Braunstein, Joel B. and Hendrix, James and Hu, Yan Helen and Mattke, Soeren and Monane, Mark and Reilly, David and Somers, Elizabeth and Teunissen, Charlotte E. and Shobin, Eli and Vanderstichele, Hugo and Weiner, Michael W. and Wilson, David and Hansson, Oskar}},
  issn         = {{1759-4758}},
  language     = {{eng}},
  number       = {{7}},
  pages        = {{426--439}},
  publisher    = {{Nature Publishing Group}},
  series       = {{Nature Reviews Neurology}},
  title        = {{Acceptable performance of blood biomarker tests of amyloid pathology — recommendations from the Global CEO Initiative on Alzheimer’s Disease}},
  url          = {{http://dx.doi.org/10.1038/s41582-024-00977-5}},
  doi          = {{10.1038/s41582-024-00977-5}},
  volume       = {{20}},
  year         = {{2024}},
}