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Blood-based biomarkers are reshaping the diagnosis of Alzheimer's disease (AD) and related neurodegenerative disorders. Phosphorylated Tau species - pTau217, pTau181, and pTau231 - now anchor the leading plasma immunoassays, while alpha-synuclein seed amplification assays are transforming Parkinson's disease (PD) research. For IVD developers and manufacturers, the reliability of these assays depends on raw materials that remain consistent from lot to lot and stay available throughout the product lifetime.
Creative Diagnostics addresses this need with a dedicated neurodegeneration antigen line: synthetic phospho-Tau peptides and BSA conjugates, recombinant Tau isoforms and pre-formed fibrils (PFFs), and alpha-synuclein antigens including pSer129 and active PFFs. Multiple lots of each key product are held in stock, and every lot is released with a Certificate of Analysis documenting consistent purity and quality.
Fig. 1. Plasma p-tau181 levels by diagnostic group, Aβ status, and ATN classification. (Chen SD, et al. (2021))
Plasma p-Tau assays require peptide calibrators, immunogens, and screening antigens with defined phosphorylation sites and reproducible quality. Our synthetic phospho-Tau peptide series covers the key diagnostic epitopes: pTau217 in two sequence variants (13-14 and 13-15), pTau181, pTau231, and pTau205. Every peptide is supplied as a free peptide or as a BSA conjugate for immunization and antibody screening, and is released with a lot-specific COA including HPLC purity analysis (≥95% across consecutive lots). Lyophilized format; reconstitute with sterile deionized water; store at -20°C.
For antibody development, assay calibration, and aggregation models, we offer full-length recombinant human Tau isoforms (2N4R/441 aa, Cat. No. DAG-WT3486; 1N4R/412 aa; 2N3R/410 aa; fetal 0N3R/352 aa; full-length 758 aa), site-specific phospho-Tau proteins (pT181, Cat. No. DAGC-55270; pT217, Cat. No. DAG-P10107), phosphorylated and non-phosphorylated Tau antigen isomer sets, and active Tau pre-formed fibrils (PFFs) covering wild-type Tau441, P301L and P301S mutants, delta-K280, K18 fragments, and the truncated dGAE (AA297-391) fibrils.
alpha-Synuclein is the central biomarker of Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy, and is increasingly measured alongside AD markers. The portfolio includes wild-type recombinant alpha-synuclein (DAG-WT195), the disease-relevant phospho-Ser129 form (DAG-WT1176), mouse alpha-synuclein (DAG-WT1175), and a comprehensive pre-formed fibril (PFF) library: Type 1 and Type 2 fibrils, N-terminally acetylated fibrils, E46K and A53T familial mutants, and beta- and gamma-synuclein PFFs as specificity controls - supporting seed amplification assays (SAA/RT-QuIC), aggregation models, and antibody validation.
To complete the neurodegeneration panel, we supply synthetic Abeta peptides (1-40, 1-42, 25-35, rat 1-42, and reverse-sequence specificity controls 40-1 and 42-1), pyroglutamate Abeta (pGlu3-42) PFFs, Abeta 1-42 PFFs, and recombinant APP proteins and fragments (Beta-APP38/39/40/42, hFc-tagged APP, GST-tagged fragments) for A beta 42/40 ratio assay development and aggregation studies.
References
*PLEASE note that these products are intended for research use only; not for diagnostic or clinical use.
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