Blennow, Kaj;
Stomrud, Erik;
Zetterberg, Henrik;
Borlinghaus, Niels;
Corradini, Veronika;
Manuilova, Ekaterina;
Muller-Hubner, Laura;
... Hansson, Oskar; + view all
(2022)
Second-generation Elecsys cerebrospinal fluid immunoassays aid diagnosis of early Alzheimer's disease.
Clinical Chemistry and Laboratory Medicine
, 61
(2)
pp. 234-244.
10.1515/cclm-2022-0516.
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Abstract
OBJECTIVES: Timely diagnosis of Alzheimer's disease (AD) is critical for appropriate treatment/patient management. Cerebrospinal fluid (CSF) biomarker analysis is often used to aid diagnosis. We assessed analytical performance of second-generation (Gen II) Elecsys® CSF immunoassays (Roche Diagnostics International Ltd), and adjusted existing cut-offs, to evaluate their potential utility in clinical routine. METHODS: Analytical performance was assessed using CSF samples measured with Elecsys CSF Gen II immunoassays on cobas e analyzers. Aβ42 Gen I/Gen II immunoassay method comparisons were performed (Passing-Bablok regression). Cut-off values were adjusted using estimated bias in biomarker levels between BioFINDER protocol aliquots/Gen I immunoassays and Gen II protocol aliquots/immunoassays. Distribution of Gen II immunoassay values was evaluated in AD, mild cognitive impairment (MCI), and cognitively normal cohorts; percentage observations outside the measuring range were derived. RESULTS: The Gen II immunoassays demonstrated good analytical performance, including repeatability, intermediate precision, lot-to-lot agreement (Pearson's r: ≥0.999), and platform agreement (Pearson's r: ≥0.995). Aβ42 Gen I/Gen II immunoassay measurements were strongly correlated (Pearson's r: 0.985-0.999). Aβ42 Gen II immunoassay cut-offs were adjusted to 1,030 and 800 ng/L, and pTau181/Aβ42 ratio cut-offs to 0.023 and 0.029, for Gen II and I protocols, respectively. No observations were below the lower limit of the measuring range; above the upper limit, there were none from the AD cohort, and 2.6 and 6.8% from the MCI and cognitively normal cohorts, respectively. CONCLUSIONS: Our findings suggest that the Gen II immunoassays have potential utility in clinical routine to aid diagnosis of AD.
| Type: | Article |
|---|---|
| Title: | Second-generation Elecsys cerebrospinal fluid immunoassays aid diagnosis of early Alzheimer's disease |
| Location: | Germany |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1515/cclm-2022-0516 |
| Publisher version: | https://doi.org/10.1515/cclm-2022-0516 |
| Language: | English |
| Additional information: | Copyright © 2022 the author(s), published by De Gruyter, Berlin/Boston. This work is licensed under the Creative Commons Attribution 4.0 International License. |
| Keywords: | Alzheimer’s disease; beta-amyloid (1–42); biomarkers; cerebrospinal fluid; phosphorylated tau 181P; total tau |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10159380 |
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