A highly sensitive and precise RUO immunoassay for measuring
p-Tau217 in blood samples

 

 

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.



At a Glance

52
fg/mL Limit of Detection (LoD)
0
Detected cross reactivity with non-phosphorylated Tau
<10
%
Non-linearity across all concentrations evaluated

 

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Learn more about our blood-based neurodegenerative biomarkers here

*Assays in development. For Research Use Only. Not for use in diagnostic procedures.

Full name: DxI 9000 Access Immunoassay Analyzer