Neurofilament light IMR Reagent

“MagQu” Neurofilament light 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 NfL in the sample easily, rapidly, and accurately

  • Magnetic Nanoparticle

  • Dextran layer

  • For Alzheimer’s disease (AD), Parkinson’s disease (PD), Huntington disease (HD) research and for in-vitro diagnosis use

Specifications

Sample type: Human Plasma

Sample volume: 60 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: 0.01 - 100 pg/ml

Low detection limit: 0.18 fg/ml

IMR standard curve of NfL

Description

Intended Use

“MagQu” Neurofilament light IMR Reagent is used to quantitatively measure neurofilament light(NfL) in human fluid specimen, such as plasma, serum or CSF.

Use “MagQu” Neurofilament light IMR Reagent only with the XacPro-S System (MagQu Co., Ltd.).

Introduction

Neurofilament light(NfL) is a specific cytoskeletal protein highly expressed in largely myelinated axons. Increased levels of NfL in CSF and blood are clinically useful biomarkers in many neurodegenerative diseases including Alzheimer’s disease (AD), Parkinson’s disease (PD), Huntington disease (HD). 1,2

Principles of Test

“MagQu” Neurofilament light IMR Reagent is designed for rapid quantifying NfL by ImmunoMagnetic Reduction (IMR). We conjugate antibody on the surface of around 50 nm-in-diameter Fe3O4 magnetic particles. When the antibodies on the surface bind with NfL, 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, NfL can be easily, rapidly and accurately quantified.3

Reagent Properties

Property Detail
Core Iron Oxide (Fe3O4)
Layer Dextran
Surface Protein Anti-Neurofilament light antibody
Mean Diameter of Particles 50 - 60 nm
Analytical Range 0.01 to 100 pg/mL neurofilament light protein
Buffer pH 7.4 PBS
Storage Temperature 2 - 8 °C

Precision

The NfL samples were measured in duplicate,

twice per day over 20 days. Two different NfL

concentrations were used for the tests. The

standard deviations of repeatability and within-lab

for various NfL concentrations ware obtained:

Interference (Specificity)

Plasma can contain interfering substances such as

hemoglobin, bilirubin, or intra lipid because of

common diseases, such as hemolysis, jaundice or

hypertriglyceridemia. Other bio-substances that

exist naturally in plasma, such as uric acid, rheuma-

toid factor, or albumin, are also interfering

substances. Other interfering substances include

drugs or chemicals in medicine that is used to treat

inflammatory diseases, viral and bacterial infec-

tions, cancers and cardiovascular disease. The level

of NfL in each of these pools was then determined

and normalized to the level without the respective

substances.


Expected Value

In this work, thirty-one normal controls (NC), fifty-two patients with Parkinson’s disease (PD) or PD dementia (PDD), and thirty-one patients with Alzheimer’s disease (AD) were enrolled at National Taiwan University Hospital and Kaohsiung Chang Gung Memorial Hospital.

Item tested Mean of measured NfL concentrations (pg/ml) Standard deviation (%CV)
Repeatability Within-Lab
pool 1 1.00 0.027 (2.67) 0.019 (1.89)
pool 2 100.17 0.528 (0.53) 1.313 (1.31)
Precision testing was determined according to CLSI/NCCLS document EP5-A3.
Substance Amount Added % Recovery
(Spike/control × 100)
Hemoglobin10000 µg/ml101.4
Conjugated bilirubin600 µg/ml97.3
Intra lipid30000 µg/ml94.3
Uric acid200 µg/ml96.4
Rheumatoid factor500 IU/ml99.5
Albumin60000 µg/ml101.7
Acetylsalicylic acid500 µg/ml100.5
Ascorbic acid300 µg/ml94.7
Ampicillin sodium1000 µg/ml103.6
Quetiapine fumarate100 ng/ml102.0
Galantamine hydrobromide90 ng/ml99.0
Rivastigmine hydrogen tartrate100 ng/ml98.3
Donepezil hydrochloride1000 ng/ml102.8
Memantine hydrochloride150 ng/ml106.8
Interference testing was based on the principle of CLSI/NCCLs document EP7-A2.

(A) Measured NfL concentrations in human plasma using IMR and (B) ROC curves used for differentiating various diagnostic groups (NC: normal control, PD: Parkinson’s disease, PDD: Parkinson’s disease dementia, AD: Alzheimer’s disease, dementia: PD/PDD+AD).

Application References:

Liu HC, Lin WC, Chiu MJ, Lu CH, Lin CY, Yang SY. Development of an assay of plasma neurofilament light chain utilizing immunomag-netic reduction technology. PLoS One. 2020 Jun 12;15(6):e0234519.


Ordering Information

Order Information
Item (Cat. No.)
Package Size
· NfL IMR Reagent (MF-NFL-0060)
4 × 1 mL (64 tests)
· NfL Control Solution (CL-NFL-000T, CL-NFL-050T)
1 mL
· Calibrator-60 (CA-DEX-0060)
1 mL
· Sample testing tubes (MQ-TUB-0100)
100 tubes
· Magnetic Immunoassay Analyzer (XacPro-S361)
161 × 91 × 138 cm
Please contact us for customizable products and more information.