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03-0205-00 SMC® Human TDP-43 High Sensitivity Immunoassay Kit

The sensitivity of the Single Molecule Counting (SMC™) technology gives the SMC® Human TDP-43 High Sensitivity Immunoassay Kit unparalleled performance in the quantification of TDP-43 in human serum, plasma, and CSF.

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03-0205-00
96 well assay  
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Overview

Replacement Information
Description
Catalogue Number03-0205-00
Trade Name
  • SMC®
DescriptionSMC® Human TDP-43 High Sensitivity Immunoassay Kit
OverviewTheSMC® Human TDP-43 High Sensitivity Immunoassay Kit contains all reagents required to perform the assay. This assay takes advantage of a standard immunoassay workflow configured in a standard plate format. Assay protocols are similar to existing sandwich ELISA methods with two key differences: 1) Elution buffer disrupts the sandwich, separating the labeled detection antibody for quantification. 2) The Erenna® and SMCxPRO™ immunoassay systems detect analytes using Single Molecule Counting (SMC™) technology.
Background InformationThe Single Molecule Counting (SMC®) Human TDP-43 High Sensitivity Immunoassay uses a quantitative fluorescent sandwich immunoassay technique to measure TAR DNA-binding protein 43 in Human Serum, Plasma, and Cerebrospinal Fluid samples. A capture antibody specific for Human TDP-43 has been pre-coated onto paramagnetic microparticles (beads). The user pipettes beads, standards, and samples into uncoated microplate wells. During incubation, the TDP-43 present in the sample binds to the capture antibody on the coated beads. Unbound molecules are washed away during the subsequent wash steps. Fluor-labeled detection antibody is added to each well and incubated. This detection antibody recognizes and binds to TDP-43 that has been captured onto the beads, thus completing the immunosandwich. Elution buffer is then added and incubated. The elution buffer dissociates the bound protein sandwich from the bead surface releasing the labeled antibodies. These antibodies are separated during transfer to a final microplate. The plate is loaded into the SMCxPRO® System where the labeled molecules are detected and counted. The number of fluor-labeled detection antibodies counted is directly proportional to the amount of TDP-43 present in the sample when captured. The amount of TDP-43 in unknown samples is interpolated from a standard curve.
References
Product Information
Components
  • Assay Buffer
  • TDP-43 Coated Beads
  • Standard Diluent
  • TDP-43 Detection Antibody
  • TDP-43
    Standard
  • 10X Wash Buffer
  • Buffer D
  • Elution Buffer B
Precision, %
  • The assay variations of SMC® Human TDP-43 Immunoassay kit were studied using five normal plasma samples run in triplicate by 3 different operators on 3 different days.
  • Intra-assay CV% average : ≤ 7%
  • Inter-assay CV% average : ≤ 11%
Quality LevelMQ200
Applications
ApplicationThe sensitivity of the Single Molecule Counting (SMC™) technology gives the SMC® Human TDP-43 High Sensitivity Immunoassay Kit unparalleled performance in the quantification of TDP-43 in human serum, plasma, and CSF.
Key Applications
  • Single Molecule Counting (SMC®)
Application NotesThe human Transactive Response DNA-binding Protein 43 (TDP-43) is a transcriptional repressor which can bind to both DNA and RNA, and regulate functions such as mRNA splicing, microRNA biogenesis, and transcription. While this 414 amino acid long protein can be found in a variety of tissue types, it is most frequently studied in the context of neuroscience research, as misfolding, phosphorylation, and aggregation of TDP-43 in neurons can has been observed in a variety of neurodegenerative disorders, including frontotemporal dementia (FTL), amyotrophic lateral sclerosis (ALS), and certain subsets of Alzheimer’s disease patients. Recent research has been focused on evaluating TDP-43 as a biomarker for FTL and ALS in both cerebrospinal fluid (CSF) and plasma, underpinning the critical nature of accurate and precise immunoassays for detecting this protein in these samples. Using the new SMC® Human TDP-43 High Sensitivity Immunoassay Kit scientists can measure this analyte CSF and blood-based samples even at low abundance, enabling studies profiling the accumulation of TDP-43 from health to disease, towards evaluation of potential therapies for conditions such as FTL and ALS.

This new streamline kit has the following features:

• Improved options for sample prep and incubation
• Lyophilization protein standard for uniform shipping and storage condition
• Increased reagent volumes to accommodate automation
• Rigorously developed to achieve accurate and reproducible performance on the state-of-the-art SMCxPRO® ultrasensitive immunoassay system.
Biological Information
Species Reactivity NoteSpecificity to the following species samples were tested with the follow results:
Non-Human Primate – 100% (n=4)
Canine – 100% (n=4)
Feline – 50% (n=4)
Rat – 0% (n=4)
Mouse – 0% (n=4)
Cross ReactivityCross-reactivity to the following analytes were tested with the following results:
p-α-synuclein 129 – not cross reactive
pTau 181 – not cross reactive
Accuracy
  • Minimum of 4 serum samples spiked with average recovery of 96% with a range of 84-111%
  • Minimum of 4 plasma samples spiked with average recovery of 100% with a range of 85-110%
  • Minimum of 5 CSF samples spiked with average recovery of 89% with a range of 82-98%
Physicochemical Information
Sensitivity
  • Lower Limit of Quantification: 5.21 pg/mL
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Usage Statement
  • Unless otherwise stated in our catalog or other company documentation accompanying the product(s), our products are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.
Storage and Shipping Information
Packaging Information
Material Size96 well assay
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
03-0205-00 04065268044261

Documentation

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