Clinical validation of the Lumipulse G cerebrospinal fluid assays for routine diagnosis of Alzheimer disease
Alzheimer's Research & Therapy Dec 04, 2019
Leitão MJ, Silva-Spínola A, Santana I, et al. - In the present study, the researchers assessed the analytical performance of the Lumipulse G β-Amyloid 1-42 (restandardized to Certified Reference Materials), β-Amyloid 1-40, total Tau, and pTau 181 assays on the fully automated LUMIPULSE G600II and contrasted CSF biomarker outcomes of the Lumipulse G assays with the established manual ELISA assays (INNOTEST) from the same company (Fujirebio), as well as established cut-off values and the clinical performance of the Lumipulse G assays for Alzheimer disease (AD) diagnosis. They performed method comparison and clinical evaluation on 40 neurological controls (NC) and 80 individuals with a diagnosis of probable AD supported by a follow-up ≥ 3 years and/or positive amyloid PET imaging. In addition, a small validation cohort of 10 NC and 20 AD individuals was involved to validate the cut-off values obtained on the training cohort. Data reported that the maximal observed intra-assay and inter-assay coefficients of variation (CVs) were 3.25% and 5.50%, respectively. Method comparisons showed correlation coefficients ranging from 0.89 (for Aβ40) to 0.98 (for t-Tau), with those for Aβ42 (0.93) and p-Tau (0.94) in-between. Overall, the authors concluded that the Lumipulse G assays demonstrate a very good analytical quality which makes them ideal for clinical routine measurements of CSF. The good clinical agreement between the Lumipulse G and INNOTEST assays facilitates the routine practice implementation of the new method.
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