Quantification of blood-based biomarkers by using an ultrasensitive digital ELISA platform

Takahiko Tokuda, Harutsugu Tatebe

Department of Functional Brain Imaging, Institute for Quantum Medical Science, National Institutes for Quantum Science and Technology （QST）

Accurate and sensitive biomarkers, especially blood-based molecular markers, are needed to aid in the diagnosis of Alzheimer’s disease （AD） and other dementia diseases.　Simoa system （Quanterix） is an ultrasensitive digital array technology, which is one of the recent innovations in the field of biomarker development.　Using this Simoa technology, we have developed a novel immunoassay able to quantify plasma tau phosphorylated at threonine 181 （p-tau181） in 2017.　Our study and subsequent studies suggest that several plasma p-tau species are promising blood biomarkers for brain tau pathology.　There is emerging evidence suggesting the usefulness of plasma biomarkers for AD pathologies, including p-tau, ratio of Aβ42/Aβ40, neurofilament light chain （NFL） and so on.　Further, large-scale, longitudinal and population-based cohort studies to validate their usefulness are needed to realize blood-based biomarkers for the diagnosis and evaluation of disease severity of AD in clinical practice.

Address correspondence to Dr. Takahiko Tokuda, Department of Functional Brain Imaging, Institute for Quantum Medical Science, National Institutes for Quantum Science and Technology （QST）（4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-0024, Japan）