Immuno-Diagnostics Antibodies and Antigens for Alzheimer's Disease (AD)
What is Alzheimer's Disease (AD)?
The most common form of dementia, Alzheimer's disease is a neurodegenerative disorder largely defined by the memory loss and subsequent drop in cognitive ability. The disease is almost always of the elderly, predominantly over the age of 65. But some people get early onset Alzheimer's disease, and start to exhibit symptoms earlier than that [1-2].
Pathological Changes
The neuropathological hallmarks of Alzheimer's disease primarily include:
1. Amyloid Plaques: These are aggregates formed from protein fragments due to the abnormal cleavage of amyloid precursor protein.
2. Neurofibrillary Tangles: These tangles occur because abnormal tau protein builds up in the cytoplasm of neurons, and disrupts the intracellular transport system.
Diagnosis
1. Clinical Symptom Assessment
2. Neuropsychological Testing
3. Brain Imaging Techniques
4. Biomarker Testing (Aβ42, p-tau217, p-tau181, p-tau231, GFAP, NfL)
Figure 1. Microfluidic Platforms to Unravel Mysteries of Alzheimer's Disease: How Far Have We Come? by Pragya Prasanna / Source: Researcher.net
Validation data
- p-tau181/p-tau217/p-tau231
- Aβ40/Aβ42
Good performance of GeneMedi's p-tau/tau antibodies in ELISA Validation
1. GeneMedi's three phosphorylated tau protein antibodies (p-tau181, p-tau217, and p-tau231) demonstrate outstanding sensitivity and exceptional specificity with their corresponding phosphorylated forms in direct ELISA assays.
GeneMedi's p-tau antibodies and antigens demonstrate excellent binding affinity: GMP-h-p-tau181-Ab01 effectively binds with GMP-h-p-tau181-Ag01, GMP-h-p-tau217-Ab01 binds well with GMP-h-p-tau217-Ag01, and GMP-h-p-tau231-Ab01 shows strong binding with GMP-h-p-tau231-Ag01. These results indicate that GeneMedi's p-tau antibodies and antigens possess outstanding affinity.
Product used as below:
Cat NO. | Description |
GMP-h-p-tau181-Ab01 | Anti-Phospho-tau181 (p-tau181) mouse monoclonal antibody (mAb) |
GMP-h-p-tau181-Ag01 | Phospho-tau181 (p-tau181) antigen (peptide) |
GMP-h-p-tau217-Ab01 | Anti-Phospho-tau217 (p-tau217) mouse monoclonal antibody (mAb) |
GMP-h-p-tau217-Ag01 | Phospho-tau217 (p-tau217) antigen (peptide) |
GMP-h-tau231-Ab01 | Anti-Phospho-tau231 (p-tau231) mouse monoclonal antibody (mAb) |
GMP-h-p-tau231-Ag01 | Phospho-tau231 (p-tau231) antigen (peptide) |
Fig 1. Validation of GeneMedi's Anti-human p-tau181/p-tau217/p-tau231 antibody in direct ELISA.
A. GeneMedi's GMP-h-p-tau181-Ab01 (Anti-human p-tau181 antibody) is validated to detect the GMP-h-p-tau181-Ag01 (p-tau181 antigen (peptide)) in ELISA, EC50 = 25.26 ng/ml.
B. GeneMedi's GMP-h-p-tau217-Ab01 (Anti-human p-tau217 antibody) is validated to detect the GMP-h-p-tau217-Ag01 (p-tau217 antigen (peptide)) in ELISA, EC50 = 25.85 ng/ml.
C.
GeneMedi's GMP-h-p-tau231-Ab01 (Anti-human p-tau231 antibody) is validated to detect the GMP-h-p-tau231-Ag01 (p-tau231 antigen (peptide)) in ELISA, EC50 = 64.34 ng/ml.
The total tau antibody (GMP-h-TauAb01) does not interact with the p-tau181 (GMP-h-p-tau181-Ag01), p-tau217 (GMP-h-p-tau217-Ag01), and p-tau231 (GMP-h-p-tau231-Ag01) peptide antigen. (Data not shown)
2. In direct ELISA assays, GeneMedi's phosphorylated tau217 antibody demonstrates excellent sensitivity and precision for both full-length and peptide forms of the phosphorylated tau217 antigen. However, its ability to detect other phosphorylated antigens and total tau antigen is limited, indicating its highly specificity.
GeneMedi's GMP-h-p-tau217-Ab01 antibody demonstrates excellent binding ability with the full-length antigen GMP-h-p-tau217-Ag02 as well as the peptide GMP-h-p-tau217-Ag01. However, when interacting with the antigens GMP-h-p-tau181-Ag01, GMP-h-p-tau231-Ag01, and GMP-h-Tau-Ag01, the affinity is relatively weaker, as reflected by significant differences in EC50 values. These results indicate that GeneMedi's p-tau 217 antibody exhibits high affinity and specificity. Product used as below:
Cat NO. | Description |
GMP-h-p-tau181-Ag01 | Phospho-tau181(p-tau181) antigen (peptide) |
GMP-h-p-tau217-Ag01 | Phospho-tau217 (p-tau217) antigen (peptide) |
GMP-h-p-tau231-Ag01 | Phospho-tau231 (p-tau231) antigen (peptide) |
GMP-h-p-tau217-Ag02 | Phospho-tau217 (p-tau217) antigen (full length) |
GMP-h-Tau-Ag01 | Recombinant human MAPT/Tau/MAPTL/MTBT1 Protein |
GMP-h-p-tau217-Ab01 | Anti-Phospho-tau217 (p-tau217) mouse monoclonal antibody (mAb) |
Fig 2. Direct ELISA Binding Curves of Phosphorylated Tau217 Antibody with Various Antigens.
This graph displays the binding efficiency of the phosphorylated tau217 antibody with five different antigens in an ELISA setup. The x-axis represents the antibody concentration in a logarithmic scale (μg/ml), and the y-axis indicates the corrected absorbance, reflecting the binding efficiency between the antibody and antigens. The data illustrate that GMP-h-p-tau217-Ab01 exhibits high detection efficiency for GMP-h-p-tau217-Ag01 (peptide) with an EC50 of 4.326 ng/ml. For GMP-h-p-tau217-Ag02 (full length), the antibody demonstrates exceptionally high sensitivity, with an EC50 of only 6.943 ng/ml. Additionally, this antibody effectively detects GMP-h-p-tau181-Ag01 (peptide), GMP-h-p-tau231-Ag01 (peptide) and GMP-h-tau-Ag01 (full length) with EC50 values of 27320 ng/ml, 3563 ng/ml and 1843 ng/ml.
3. In sandwich ELISA assays, GeneMedi's p-tau217 antibody and tau antibody pair can detect the full-length phosphorylated 217 protein but are unable to detect phosphorylated 217 peptides or non-phosphorylated proteins.
Cat NO. | Description |
GMP-h-p-tau217 A g01 | Phospho-tau217 (p-tau217) antigen (peptide) |
GMP-h-p-tau217 A g02 | Phospho-tau217 (p-tau217) antigen (full length) |
GMP-h-p-tau217 Ab01 | Anti-Phospho-tau217 (p-tau217) mouse monoclonal antibody (mAb) |
GMP-h-p-tau217 Ab02 | Anti-Phospho-tau217 (p-tau217) mouse monoclonal antibody (mAb) |
GMP-h-tau-A g01 | Recombinant human MAPT/Tau/MA PTL/MTBT1 Protein |
GMP-h-tauA b01 | A nti-human MAPT/Tau/MA PTL/MTBT1 mouse monoclonal antibody (mAb) |
GMP-h-tau-A b02 | Anti-human MAPTITau/MA PTL/MTBT1 mouse monoclonal antibody (mAb) |
GMP-h-tau-A b03 | Anti-human MAPTITau/MA PTL/MTBT1 mouse monoclonal antibody (mAb) |
GMP-h-p-tau217-Ab01 is used as the capture antibody. When GMP-h-Tau-Ab03 is used as the detection antibody, the EC50 for detecting GMP-h-p-tau217-Ag02 is lower than GMP-h-Tau-Ab01, indicating GMP-h-Tau-Ab03 is more suitable as a detection antibody.
However, when detecting phosphorylated 217 peptide GMP-h-p-tau217-Ag01 or non-phosphorylated protein GMP-h-tau-Ag01, the EC50 remains high regardless of whether GMP-h-Tau-Ab03 or GMP-h-Tau-Ab01 is used, suggesting no binding for detecting peptide GMP-h-p-tau217-Ag01 or non-phosphorylated protein GMP-h-tau-Ag01 under these conditions.
Fig3. Sandwich ELISA Analysis of Full-Length Phosphorylated Tau 217 Antigen with Corresponding Phosphorylated Tau 217 Antibody and Total Tau Antibody.
A.This figure illustrates the detection efficacy of two different antibody combinations in Sandwich ELISA experiments targeting the GMP-h-p-tau217-Ag02 antigen (full length). The x-axis represents the antigen concentration displayed on a logarithmic scale (μg/ml), while the y-axis shows the corrected absorbance. The results indicate that the combination of GMP-h-p-tau217-Ab01 as the coating antibody and GMP-h-Tau-Ab01 as the detection antibody yields an EC50 of 76.55 ng/ml. Conversely, using GMP-h-p-tau217-Ab01 as the coating antibody and GMP-h-Tau-Ab03 as the detection antibody results in an EC50 of 39.02 ng/ml, demonstrating higher detection sensitivity at lower concentrations.
B.This figure demonstrates the detection results of two different detection antibodies (GMP-h-tau-Ab01 and GMP-h-tau-Ab03) against the GMP-h-tau-Ag01 antigen (full length) in an ELISA assay, using GMP-h-p-tau217-Ab01 as the coating antibody. The x-axis represents antigen concentration, displayed on a logarithmic scale (μg/ml); the y-axis shows corrected absorbance. The results reveal that when using GMP-h-tau-Ab03 as the detection antibody, the EC50 value reaches 20030 ng/ml, indicating a lower sensitivity to the antigen; whereas, when using GMP-h-tau-Ab01 as the detection antibody, the EC50 value soars to 4352000 ng/ml, demonstrating poor efficacy in detecting the antigen.
C. This figure illustrates the detection performance of four different antibody combinations in an ELISA assay targeting the GMP-h-p-tau217-Ag01 antigen (peptide). The x-axis represents antigen concentration, displayed on a logarithmic scale (μg/ml), while the y-axis shows the corrected absorbance. The curves in the figure show that all antibody combinations maintain relatively consistent absorbance changes across a range of low to high concentrations, indicating these results also reveal that the sensitivity of these four antibody combinations in detecting the GMP-h-p-tau217-Ag01 (peptide) antigen is relatively low.
Good performance of GeneMedi's Aβ40/Aβ42 antibodies in ELISA and CLIA Validation
The high-performance Aβ40 and Aβ42 antibody raw materials developed by GeneMedi have the advantages of good specificity and high sensitivity, and are the preferred raw materials for the development of in vitro diagnostics reagents for Alzheimer's disease.
In direct ELISA analysis, GMP-h-Aβ40-Ab01 and GMP-h-Aβ42-Ab01 can Recognizes Aβ40 or Aβ42 with high specificity. GMP-h-Aβ42-Ab02 has cross-reactivity with both Aβ40 and Aβ42.
In CLIA verification, the antibody pair (Capture: GMP-h-Aβ40-Ab01 , Detect: GMP-h-Aβ42-Ab02 ) can detect the GMP-h-Aβ40-Ag01, and the antibody pair (Capture: GMP-h-Aβ42-Ab02 , Detect: GMP-h-Aβ42-Ab01 ) can detect the GMP-h-Aβ42-Ag01. Beta-amyloid(1-42) antibodies (GMP-h-Aβ42-Ab02 and GMP-h-Aβ42-Ab01) established a standard curve, and the detection range of Aβ42 was 100-1700 pg/mL.
Figure 1: Good performance of GeneMedi's Aβ40/Aβ42 antibodies in ELISA and CLIA Validation
A. GMP-h-Aβ40-Ab01 and GMP-h-Aβ42-Ab02 can bind GMP-h-Aβ40-Ag01, while GMP-h-Aβ42-Ab01 can not bind the Aβ40 antigen in direct ELISA.
B. GMP-h-Aβ42-Ab01 and GMP-h-Aβ42-Ab02 can bind GMP-h-Aβ42-Ag01, while GMP-h-Aβ40-Ab01 can not bind the Aβ42 antigen in direct ELISA.
C. CLIA verification data of the antibody pair (Capture: GMP-h-Aβ40-Ab01 , Detect: GMP-h-Aβ42-Ab02 ) to detect the GMP-h-Aβ40-Ag01.
D. CLIA verification data of the antibody pair (Capture: GMP-h-Aβ42-Ab02 , Detect: GMP-h-Aβ42-Ab01 ) to detect the GMP-h-Aβ42-Ag01.
Biomarkers for Alzheimer's Disease
Biomarker | Limit (Pathological concentration in blood) |
---|---|
Phospho-tau181 (p-tau181) | >3 pg/ml |
Phospho-tau217 (p-tau217) | >10 pg/ml |
Phospho-tau231(p-tau231) | >10 pg/ml |
Phospho-tau212 and 214 (p-tau212 and 214) | / |
Phospho-tau202 and 205 (p-tau202 and 205) | / |
Phospho-tau413 (p-tau413) | / |
Phospho-tau422 (p-tau422) | / |
Tau proteins (Tau) | >100 pg/ml |
Neurofilament light chain (NfL) | >30 pg/ml |
Glial fibrillary acid protein (GFAP) | >100 pg/ml |
Beta-amyloid 42 (Aβ42) | / |
Beta-amyloid 38 (Aβ38) | / |
Beta-amyloid 40 (Aβ40) | / |
Monocyte chemoattractant protein-1 (MCP-1/CCL2) | / |
Neurogranin protein (Neurogranin) | / |
Neuron-specific enolase (NSE) | / |
sTREM2 | / |
Visinin-like protein 1 (VLP-1) | / |
Chitinase-3-like protein 1 (CHI3L1/YKL-40) | / |
Alpha-synuclein (α-synuclein) | / |
Apolipoprotein E (APOE4) | / |
AD-associated neuronal thread protein (AD7c-NTP) | / |
Heart fatty acid-binding protein (HFABP) | / |
Sample Types: Blood, cerebrospinal fluid (CSF)
Clinical Applications and Research in Alzheimer's Disease Diagnostics
Name | Sample | Biomarkers | Method |
---|---|---|---|
Roche | Blood | P-tau217 | ECL |
CSF | P-tau181/Aβ42 ratio | ECL | |
Blood | P-tau181+APOE E4 | ECL | |
C2N Diagnostics | Blood | Aβ42/40 ratio and p-tau217 ratio | LC-MS |
Quest Diagnostics | Blood | Aβ42/40 | LC-MS/MS |
Blood | P-tau217 | ECLIA | |
Blood | P-tau181 | IA | |
Quanterix | Blood | P-tau181 | Simoa |
Blood | NfL | Simoa | |
Blood | P-tau217 | Simoa | |
Alzpath | Blood | P-tau217 | Simoa |
Labcorp | Blood | P-tau217 | CLEIA |
Blood | Aβ42/40 | CLEIA | |
Blood | GFAP | CLEIA | |
Blood | P-tau181 | CLEIA | |
Blood | NfL | CLEIA |