Concordance and diagnostic accuracy between Innotest and two fully automated platforms: Elecsys and Lumipulse. (31st December 2021)

• Record Type: Journal Article
• Authors: Ortega, Ricard López; Dakterzada, Faride; Arias, Alfonso; Llena, Iolanda Riba; Julián, Maria Ruiz; Huerto, Raquel; Tahan, Nuria; Piñol‐Ripoll, Gerard
• Is Part Of: Alzheimer's & dementia. Volume 17(2021)Supplement 5
• Page Start: n/a
• Page End: n/a
• Publication Date: 2021-12-31
• Subjects: Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.053042
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Background: Manual ELISA assays are the most commonly used methods for quantification of CSF AD biomarkers; however, they show inter‐ and intra‐laboratory variability. We compared the Innotest ELISA method with two fully automated platforms (Lumipulse and Elecsys) to determine whether these new methods can provide effective substitutes for ELISA assays. Method: We included 149 males and females with AD (n = 34), MCI (n = 94) and non‐AD dementias (n = 21). Aβ42, T‐tau, and P‐tau were quantified using the ELISA method (Innotest, Fujirebio Europe), CLEIA method on a Lumipulse G600II, and ECLIA method on a Cobas e 601 instrument. Result: We found a high correlation between the three methods. Both Lumipulse and Elecsys methods were highly concordant with clinical diagnoses, and the combination of Lumipulse Aβ42 and P‐tau had the highest discriminating power (AUC 0.915, 95% CI 0.822–1.000). The use of Aβ42/Aβ40 ratio instead of Aβ42 alone in AT(N) classification enhanced the diagnostic accuracy (AUC 0.798, 95% CI 0.649–0.947 vs AUC 0.778, 95% CI 0.617–0.939). Finally, the biomarker ratios (P‐tau/Aβ42 and T‐tau/Aβ42) were more consistent with the Aβ42/Aβ40 ratio for both Lumipulse and Elecsys methods, and Elecsys P‐tau/Aβ42 had the highest consistency with amyloid pathology (AUC 0.994, 95% CI 0.986–1.000 and OPA 96.4%). Conclusion: The Lumipulse and Elecsys CSF AD assays showed high analytical and clinical performances so their use is recommended for the measurement of CSF AD biomarkers compared with unstandardized manual methods.