Abstract
Immunomagnetic reduction (IMR), which involves the use of antibody-functionalized magnetic nanoparticles to specifically label target biomarkers, was utilized to develop an assay for total tau protein in human plasma. The analytic properties of the IMR assay on tau protein were investigated. The limit of detection was found to be 0.026 pg/ml. Other properties such as Hook effect, assay linearity, dilution recovery range, reagent stability, interference test, and spiked recovery were also characterized. The ultra-sensitive IMR assay was applied to detect the plasma tau protein levels of subjects with prevalent neurodegenerative diseases, such as Alzheimer’s disease (AD), mild cognitive impairment (MCI) due to AD, Parkinson’s disease (PD), frontotemporal dementia (FTD) and vascular dementia (VD). The concentrations of plasma tau protein in patients with VD, PD, MCI due to AD, FTD, and AD patients were higher than that of healthy controls. Using an ROC curve analysis, the cutoff value for discriminating dementia patients from healthy controls was 17.43 pg/ml, resulting in 0.856 and 0.727 for clinical sensitivity and specificity, respectively. The area under the ROC curve was 0.908. These results imply that the IMR plasma tau assay would be useful to screen for prevalent neurodegenerative diseases.
Highlights
Tau protein is abundant in neurons in the central nervous system[1,2,3]
Phosphate buffered saline (PBS) solutions spiked with various concentrations of tau protein, present as six isoforms (T7951; Sigma-Aldrich), were used as samples for Immunomagnetic reduction (IMR) measurements
The tau reagent consisting of magnetic nanoparticles functionalized with antibodies and dispersed in PBS solution has been developed for IMR assay
Summary
Tau protein is abundant in neurons in the central nervous system[1,2,3]. Its main function is to stabilize axonal microtubules[4,5,6]. The elevation of CSF tau protein levels was found in patients with frontotemporal dementia (FTD). Independent studies have revealed that concentrations of CSF tau protein in FTD are between those of AD and healthy controls[11,12,13]. This result implies that the neurofibrillary tangle formation occurs in FTD patients. In the 2010s, the exploration of tau protein in CSF was not limited to AD and FTD but was initiated for patients suffering from Parkinson disease (PD) or dementia with Lewy bodies (DLB). 1. Subjects must meet the diagnostic guideline for frontotemporal lobe degeneration (mainly primary progressive aphasia)[40 2]. Three or more of the following symptoms: unilateral onset, rest tremor present, progressive disorder, persistent asymmetry affecting the side of onset most, excellent response to levodopa, severe levodopa-induced chorea, levodopa response for over 5 years, and clinical course of over 10 years
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