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Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer's disease assessment : findings from the Apollo study

Schinke, Henrik ; Förnvik Jonsson, Magnus LU orcid ; Gummesson, Mayme ; Nilsson, Rikard ; Gaupp, Stefanie ; Manuilova, Ekaterina ; McIlwrick, Silja ; Weinberger, Jan-Philipp ; Rutz, Sandra and Carboni, Margherita , et al. (2025) In Clinical Chemistry and Laboratory Medicine p.1-11
Abstract

OBJECTIVES: The Apollo study was designed to support the clinical performance verification of the adjusted cutoffs of the Elecsys® β-Amyloid(1-42) (Aβ42) cerebrospinal fluid (CSF) II, β-Amyloid(1-40) (Aβ40) CSF, Phospho-Tau (181P) (pTau) CSF and Total-Tau (tTau) CSF immunoassays (Roche Diagnostics International Ltd) for measuring fresh CSF samples, and assess the concordance of the Elecsys CSF pTau/Aβ42, tTau/Aβ42 and Aβ42/Aβ40 ratios, as well as Aβ42 alone, with amyloid positron emission tomography (PET) visual read status.

METHODS: The primary study endpoint was to assess the concordance of the Elecsys CSF ratios and Aβ42 alone with amyloid PET visual read status using fresh CSF samples collected from individuals with subjective... (More)

OBJECTIVES: The Apollo study was designed to support the clinical performance verification of the adjusted cutoffs of the Elecsys® β-Amyloid(1-42) (Aβ42) cerebrospinal fluid (CSF) II, β-Amyloid(1-40) (Aβ40) CSF, Phospho-Tau (181P) (pTau) CSF and Total-Tau (tTau) CSF immunoassays (Roche Diagnostics International Ltd) for measuring fresh CSF samples, and assess the concordance of the Elecsys CSF pTau/Aβ42, tTau/Aβ42 and Aβ42/Aβ40 ratios, as well as Aβ42 alone, with amyloid positron emission tomography (PET) visual read status.

METHODS: The primary study endpoint was to assess the concordance of the Elecsys CSF ratios and Aβ42 alone with amyloid PET visual read status using fresh CSF samples collected from individuals with subjective cognitive decline or mild cognitive impairment, handled with a new routine-use pre-analytical procedure and measured with the Elecsys CSF immunoassays. The sample stability after 1- to 13-week storage at -20 °C was also investigated in an exploratory analysis.

RESULTS: Of 108 screened individuals, 91 met the eligibility criteria, of whom 44.0 % were amyloid PET-positive and 56.0 % amyloid PET-negative. Positive percent agreement (PPA) and negative percent agreement, respectively, were 0.800 and 0.882 for pTau/Aβ42, 0.775 and 0.902 for tTau/Aβ42, and 0.950 and 0.824 for Aβ42/Aβ40. For Aβ42, PPA was 0.975 and negative likelihood ratio was 0.039. Overall, 33 samples (36.3 %) were frozen at -20 °C for 1-13 weeks. All concentration recoveries were within 100 ± 10 % when stored at -20 °C for ≤8 weeks.

CONCLUSIONS: Elecsys CSF ratios and Aβ42 alone may be reliable alternatives to amyloid PET for identifying amyloid positivity in clinical practice.

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organization
publishing date
type
Contribution to journal
publication status
epub
subject
in
Clinical Chemistry and Laboratory Medicine
pages
1 - 11
publisher
De Gruyter
external identifiers
  • pmid:40068924
  • scopus:86000570446
ISSN
1434-6621
DOI
10.1515/cclm-2024-1476
language
English
LU publication?
yes
additional info
© 2025 the author(s), published by De Gruyter, Berlin/Boston.
id
e37070d3-aed3-42e2-a87c-7e90b147b988
date added to LUP
2025-05-27 15:43:19
date last changed
2025-07-09 07:46:16
@article{e37070d3-aed3-42e2-a87c-7e90b147b988,
  abstract     = {{<p>OBJECTIVES: The Apollo study was designed to support the clinical performance verification of the adjusted cutoffs of the Elecsys® β-Amyloid(1-42) (Aβ42) cerebrospinal fluid (CSF) II, β-Amyloid(1-40) (Aβ40) CSF, Phospho-Tau (181P) (pTau) CSF and Total-Tau (tTau) CSF immunoassays (Roche Diagnostics International Ltd) for measuring fresh CSF samples, and assess the concordance of the Elecsys CSF pTau/Aβ42, tTau/Aβ42 and Aβ42/Aβ40 ratios, as well as Aβ42 alone, with amyloid positron emission tomography (PET) visual read status.</p><p>METHODS: The primary study endpoint was to assess the concordance of the Elecsys CSF ratios and Aβ42 alone with amyloid PET visual read status using fresh CSF samples collected from individuals with subjective cognitive decline or mild cognitive impairment, handled with a new routine-use pre-analytical procedure and measured with the Elecsys CSF immunoassays. The sample stability after 1- to 13-week storage at -20 °C was also investigated in an exploratory analysis.</p><p>RESULTS: Of 108 screened individuals, 91 met the eligibility criteria, of whom 44.0 % were amyloid PET-positive and 56.0 % amyloid PET-negative. Positive percent agreement (PPA) and negative percent agreement, respectively, were 0.800 and 0.882 for pTau/Aβ42, 0.775 and 0.902 for tTau/Aβ42, and 0.950 and 0.824 for Aβ42/Aβ40. For Aβ42, PPA was 0.975 and negative likelihood ratio was 0.039. Overall, 33 samples (36.3 %) were frozen at -20 °C for 1-13 weeks. All concentration recoveries were within 100 ± 10 % when stored at -20 °C for ≤8 weeks.</p><p>CONCLUSIONS: Elecsys CSF ratios and Aβ42 alone may be reliable alternatives to amyloid PET for identifying amyloid positivity in clinical practice.</p>}},
  author       = {{Schinke, Henrik and Förnvik Jonsson, Magnus and Gummesson, Mayme and Nilsson, Rikard and Gaupp, Stefanie and Manuilova, Ekaterina and McIlwrick, Silja and Weinberger, Jan-Philipp and Rutz, Sandra and Carboni, Margherita and Stomrud, Erik}},
  issn         = {{1434-6621}},
  language     = {{eng}},
  month        = {{03}},
  pages        = {{1--11}},
  publisher    = {{De Gruyter}},
  series       = {{Clinical Chemistry and Laboratory Medicine}},
  title        = {{Concordance between the updated Elecsys cerebrospinal fluid immunoassays and amyloid positron emission tomography for Alzheimer's disease assessment : findings from the Apollo study}},
  url          = {{http://dx.doi.org/10.1515/cclm-2024-1476}},
  doi          = {{10.1515/cclm-2024-1476}},
  year         = {{2025}},
}