Blennow, Kaj; Stomrud, Erik; Zetterberg, Henrik; Borlinghaus, Niels; Corradini, Veronika; Manuilova, Ekaterina; Muller-Hubner, Laura; ... Hansson, Oskar; + view all Blennow, Kaj; Stomrud, Erik; Zetterberg, Henrik; Borlinghaus, Niels; Corradini, Veronika; Manuilova, Ekaterina; Muller-Hubner, Laura; Quevenco, Frances-Catherine; Rutz, Sandra; Hansson, Oskar; - view fewer (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.

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