Phosphorylated Tau protein [pT181] IMR

“MagQu” Phosphorylated Tau protein [pT181] IMR Reagent is designed for quantitative measurement of Tau protein concentration in human plasma by immunomagnetic reduction (IMR) assay. The reagent can be used with MagQu’s Magnetic Immunoassay Analyzer XacPro-S system.
This assay enables early-stage neurological disease research with ultra-high sensitivity and low interference.

Features

Quantify phosphorylated Tau protein (p-Tau181) in the sample easily, rapidly, and accurately
Magnetic Nanoparticle
Dextran layer
For Alzheimer’s disease research and for in-vitro diagnosis use

Specifications

Sample type: Human Plasma

Sample volume: 40 μl

Assay time: 5 hours (36 channels in XacPro-S)

Use application: In vitro diagnostic

Detection methods: ImmunoMagnetic Reduction (by analyzer XacPro-S with magnetic reagents)

Sensitivity

Detection Range: 0.196 - 100 pg/ml

Low detection limit: 19.6 fg/ml

IMR standard curve of Tau [pT 181]

Description

Intended Use

“MagQu” Phosphorylated Tau protein [pT181] IMR Reagent is used to quantitatively measure phosphorylated Tau protein(p-Tau181) in human fluid specimen, such as plasma, serum or CSF.

Use “MagQu” Phosphorylated Tau protein [pT181] IMR Reagent only with the XacPro-S System (MagQu Co., Ltd.).

Introduction

Tau protein is a microtubule-associated protein and is abundant in nervous system. Tau protein can maintain the structure of neuron cells and support the transport of substance. When tau proteins phosphorylated, It will result in the self-assembly of tangles in brain and increased some neurodegenerative diseasesincluding Alzheimer’s disease (AD)、Pick's disease、Parkinson's disease (PD)、Progressive supranuclear palsy(PSP) and Corticobasal degeneration (CBD). The phosphorylated Tau protein at position threonine 181 (p-Tau181) is more specific for disease progression (from mild cognitive impairment to Alzheimer's disease)1

Principles of Test

“MagQu” Phosphorylated Tau protein [pT181] IMR Reagent is designed for rapid quantifying phosphorylated Tau protein(p-Tau181) by Immuno Magnetic Reduction (IMR). We conjugated the antibody on the surface of around 50 nm-in-diameter Fe3O4 magnetic particles. When the antibodies on the surface bind with phosphorylated Tau protein (p-Tau181), the magnetic particles form clusters. Therefore, the ac susceptibility (Xac) of magnetic particles would be reduced in the adding ac magnetic field. By measuring the reduction of Xac, we can quantify phosphorylated Tau protein(p-Tau181) in the sample easily, rapidly, and accurately.2,3

Reagent Properties

Property	Detail
Core	Iron Oxide (Fe₃O₄)
Layer	Dextran
Surface protein	Anti-phosphorylated Tau protein(p-Tau181) antibody
Mean Diameter of Particles	50 ~ 60 nm
The analytical range of reagent	0.019569 to 100 pg/mL phosphorylated Tau protein(p-Tau181)
Buffer	ddH₂O
Storage temp.	2 ~ 8 ℃

Precision

The Tau [pT181] samples were measured in

duplicate, twice per day over 20 days. Two

measurements on two sequent days are

regarded as two runs. Two different Phospho-

rylated Tau Protein [pT181] concentrations

were used for the tests. The standard devia-

tions of repeatability and within-lab for various

Tau [pT181] concentrations ware obtained.

Interference (Specificity)

The level of Phosphorylated Tau Protein [pT181] in each of

these pools was then determined and normalized to the

level without the respective substances. All % Recoveries

were in the range of 90-110%, indicating that the reagent is

unaffected by the following levels of interfering

substances.

Expected Value

Fig 1: The measured concentrations of plasma p-tau181 were 2.46±1.09 pg/ml for healthy controls, 4.41±1.85 pg/ml for MCI due to AD, and 6.14±1.59 pg/ml for very mild AD. (refer to reference 1)

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REF	Item tested	Mean of measured tau [pT181] concentrations (pg/ml)	Standard deviation (%CV)
REF	Item tested	Mean of measured tau [pT181] concentrations (pg/ml)	Repeatability	Within-Lab
MF-PT1-0060	pool 1	1.96	0.05786 (5.8)	0.08015 (8.0)
MF-PT1-0060	pool 2	22.62	0.03636 (3.6)	0.04256 (4.3)
MF-PT1-006B	pool 1	0.01	0.17407 (17.4)	0.23029 (23.0)
MF-PT1-006B	pool 2	102.76	0.01227 (1.2)	0.09752 (9.8)

Precision testing was determined according to CLSI/NCCLs document EP5-A2.

Substance	Amount Added (MF-PT1-0060)	Amount Added (MF-PT1-006B)
Bilirubin	600 µg/ml	900 µg/ml
Hemoglobin	10 mg/ml	150 µg/ml
Intra lipid (Lepemis)	30 mg/ml	300 µg/ml
Albumin	60 mg/ml	1500 µg/ml
Rheumatoid factor	500 IU/ml	4 IU/ml
Uric acid	200 µg/ml	90 µg/ml
Acetylsalicylic acid	500 µg/ml	300 µg/ml
Ascorbic acid	300 µg/ml	525 µg/ml
Ampicillin sodium	1 mg/ml	1 mg/ml
Rivastigmine hydrogen tartrate	100 ng/ml	150 µg/ml
Donepezil hydrochloride	1 µg/ml	1 µg/ml
Memantine hydrochloride	150 ng/ml	1200 ng/ml
Galantamine hydrobromide	100 ng/ml	90 µg/ml
Quetiapine fumarate	90 ng/ml	1 µg/ml
Human Anti-Mouse Antibody (HAMA)	100 ng/ml	-
Tau protein	100 ng/ml	-
Aβ1-40 protein	100 pg/ml	-
Aβ1-42 protein	100 pg/ml	-
α-synuclein	10 pg/ml	-

Interference testing was based on the principle of CLSI/NCCLs document EP7-A2.

Fig 2: p-Tau181 were significantly increased in all disease groups compared to controls, especially in patients with FTD (p < 0.01).(refer to reference 2)

Application References:

1. Yang CC, Chiu MJ, Chen TF, Chang HL, Liu BH, Yang SY. Assay of Plasma Phosphorylated Tau Protein (Threonine 181) and Total Tau Protein in Early-Stage Alzheimer's Disease. J Alzheimers Dis. 2018;61(4):1323-1332

2. Lin CH, Yang SY, Horng HE, Yang CC, Chieh JJ, Chen HH, Liu BH, Chiu MJ. Plasma Biomarkers Differentiate Parkinson's Disease From Atypical Parkinsonism Syndromes. Front Aging Neurosci. 2018 Apr 27;10:123