B-010 Evaluation of Analytical Performance of Amyloid Beta 40, 42, pTau-181, pTau-217, NfL, and APOE4 on the full-automated DZ-Lite i2000 Analyzer for Alzheimer’s Disease Diagnosis

Abstract Background Alzheimer*s disease (AD), a leading cause of dementia, requires reliable and accessible diagnostic tools for early detection and monitoring. Current methods, such as cerebrospinal fluid (CSF) analysis and positron emission tomography (PET), are accurate but often impractical due to high costs and invasiveness. The most common methodologies for AD diagnostics, such as high-sensitivity ELISA or analyzer-based methods, rely on CSF samples. However, these methods are not suitable for large-scale, routine testing. Recent advancements in blood-based biomarkers present a promising alternative, offering a less invasive, cost-effective, and more accessible approach for early diagnosis and monitoring. In this context, our work differentiates itself by developing assays that are specifically sensitive to plasma samples, enabling routine assessment in a high-throughput manner. Methods This study evaluates the analytical performance of a comprehensive panel of six biomarkers: Amyloid beta 40 (Aß40), Amyloid beta 42 (Aß42), phosphorylated tau 181 (pTau-181), phosphorylated tau 217 (pTau-217), neurofilament light chain (NfL), and Apolipoprotein E4 (APOE4) on the full-automated chemiluminescence DZ-Lite i2000 analyzer. Results The assays demonstrated ultra-high sensitivity, with limits of quantification (LOQ) of 2.1 pg/mL for Aß40, 2.2 pg/mL for Aß42, 0.9 pg/mL for pTau-181, 3 pg/mL for NfL and 0.13 pg/mL for pTau-217. Additionally, the APOE4 assay was able to differentiate between the homozygote (APOE4/APOE4) and heterozygote (APOE3/APOE4) genetic types of APOE4. These assays were rigorously validated, demonstrating precision, reproducibility, stability, and accuracy across a wide range of concentrations. Conclusion This work demonstrates the development and performance of a panel of Diazyme assays on the DZ-Lite i2000 analyzer, which are accessible, easy-to-use, high-throughput, and cost-effective for clinical research on neurological diseases.