English
Hyperphosphorylated Tau is a pathologic hallmark of the neurofibrillary tangles in Alzheimer’s disease, and plasma levels of p-Tau217* are correlated with amyloid pathology. There are a few p-Tau217 blood-based RUO assays available for research use today. To detect this biomarker in the blood, there is a need for an increased level of sensitivity and precision. In this study, scientists evaluated the Beckman Coulter research-use-only (RUO) p-Tau217 immunoassay on the DxI 9000 Immunoassay Analyzer† and compared the results with those from the Quanterix/ALZpath Simoa p-Tau217 RUO assay.
The study found:
- Comparison between the Beckman Coulter RUO p-Tau217 assay and the Quanterix/ALZpath Simoa p-Tau217 assay showed good correlation with a slight positive bias
- Non-linearity was 10% and imprecision was <12% across all tested concentrations (less than 10% for samples >200 fg/mL)
- Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) estimates demonstrated remarkable low-end precision
- Low-end precision of the Beckman Coulter RUO p-Tau217 assay demonstrated analytical sensitivity capable of detecting and quantitating p-Tau 217 concentrations with no detection of cross reactivity to non-phosphorylated Tau and no significant interference with Alzheimer's disease medications (Donepezil, Memantine, Aripirazole, Galantamine, and Rivastigamine)
The Beckman Coulter RUO p-Tau217 assay is a promising blood-based biomarker for Alzheimer’s disease research and drug development. The DxI 9000 analyzer has the analytical sensitivity capabilities to detect and quantitate p-Tau217 concentrations in cognitively healthy and amyloid-negative populations.
At Beckman Coulter, we are committed to revolutionizing the next generation in immunoassay testing with precision and sensitivity to drive innovations, advance medical insights, and enhance diagnostic availability.
