Recombinant Human Tau (MAPT) Protein for Alzheimer's Disease CLIA IVD Development
Tau protein (encoded by the MAPT gene — Microtubule-Associated Protein Tau) is a neuronal microtubule-associated protein primarily expressed in the axons of central nervous system neurons. In the adult human brain, six major Tau isoforms are expressed through alternative splicing of exons 2, 3, and 10 of the MAPT gene, ranging from 352 to 441 amino acids (designated 0N3R through 2N4R based on N-terminal inserts and microtubule-binding repeat numbers). Under normal physiological conditions, Tau binds to and stabilises microtubules in neuronal axons, maintaining the structural integrity of the cytoskeleton and supporting fast axonal transport of organelles, proteins, and vesicles from the cell body to synapses. The degree of Tau microtubule binding is regulated by reversible phosphorylation at over 80 serine and threonine residues; normal Tau contains 2–3 moles of phosphate per mole of protein. In Alzheimer's disease (AD) and other tauopathies, Tau becomes hyperphosphorylated (up to 8–10 moles of phosphate per mole), loses affinity for microtubules, and aggregates into paired helical filaments (PHF) that accumulate as neurofibrillary tangles (NFTs) — a defining neuropathological hallmark of AD.
Tau and phosphorylated Tau (pTau) are the core biomarkers for Alzheimer's disease diagnosis and staging. The NIA-AA 2018 Research Framework defines the AT(N) biological classification: the T biomarker refers to tau pathology, measured as CSF pTau/Aβ42 ratio or tau PET tracer uptake. CSF total Tau (tTau) is elevated in AD due to neurodegeneration and axonal injury; CSF pTau-181 and pTau-217 are elevated specifically in response to amyloid-beta pathology and AD tangle formation. Blood plasma pTau-217 has emerged as the most promising non-invasive AD biomarker: multiple large-scale validation studies (including Hansson et al., New England Journal of Medicine, 2023; Palmqvist et al., Nature Medicine, 2021) have demonstrated that plasma pTau-217 distinguishes Alzheimer's disease from non-Alzheimer's dementia with over 95% accuracy. The global AD patient population was estimated at 55 million in 2023 (WHO), projected to reach 139 million by 2050, creating an enormous unmet diagnostic need addressable by blood-based Tau IVD assays.
For IVD developers building Tau and pTau CLIA or ELISA sandwich assays, Sekbio offers Tau-W32P — a recombinant full-length human MAPT/Tau protein with C-terminal His tag (45.8 kDa, ≥95% purity by SDS-PAGE, lyophilized). Tau-W32P serves three key development functions: first, antibody screening and epitope mapping to identify optimal anti-Tau antibody candidates for CLIA capture and detection roles; second, calibration standard preparation for tTau CLIA assay standard curves; and third, high-throughput antibody pairing validation to identify non-competing capture/detection antibody pairs for sandwich CLIA development. The C-His tag on Tau-W32P enables convenient verification by Western blot using standard anti-His antibodies. Contact info@sekbio.com for customised Tau protein quantities or to enquire about phospho-Tau variants (pTau-181, pTau-217) for pTau assay development.
Recombinant full-length human Tau (MAPT) protein for Alzheimer's disease CLIA and ELISA assay development, antibody screening, and calibration standard preparation.
| Catalog No. | Product Name | Type | Purity | Intended Use | Storage |
|---|---|---|---|---|---|
| Tau-W32P | Recombinant Human MAPT/Tau Protein (C-His tag) | Recombinant Protein | ≥95% SDS-PAGE | CLIA/ELISA calibration & antibody screening | −70°C or −20°C |
Tau-W32P: lyophilized, buffer 50 mM Tris-HCl pH 7.5 + 5% trehalose. MOQ and pricing: contact info@sekbio.com. Custom pTau variants (pTau-181, pTau-217) available on enquiry.
Purpose-built for the sensitivity, purity, and specificity required in next-generation Tau and pTau CLIA IVD assay development.
Tau-W32P is a full-length recombinant human MAPT/Tau protein (45.8 kDa) expressed in E. coli with ≥95% purity by SDS-PAGE. Full-length Tau contains all six major isoform-spanning epitopes, enabling comprehensive antibody screening across the entire Tau sequence. Higher purity (≥95%) versus standard reagent-grade proteins (>90%) reduces non-specific binding in CLIA microparticle assays, improving assay sensitivity at the low CSF and plasma Tau concentrations typical of early AD.
The C-terminal His tag on Tau-W32P enables rapid protein verification by Western blot using standard anti-His antibodies, without requiring Tau-specific antibodies at the QC stage. His-tag pull-down also enables affinity-based protein capture for antibody epitope competition studies. This is particularly valuable during the antibody screening phase of Tau CLIA development, where distinguishing capture versus detection antibody positions requires systematic epitope mapping.
Tau-W32P is supplied in lyophilized (freeze-dried) format in 50 mM Tris-HCl pH 7.5 + 5% trehalose buffer. Lyophilized proteins have significantly longer shelf life than liquid formulations and are more resistant to temperature excursions during shipping — critical for international OEM supply chains. Storage at −70°C (preferred) or −20°C. Lyophilized format also simplifies customs clearance and cold chain management for global customers.
Tau (tTau) and phosphorylated Tau (pTau-181, pTau-217, pTau-231) are the primary Alzheimer's disease biomarkers in both CSF (gold standard since Blennow et al., 1995) and blood plasma (emerging standard since 2020). Regulatory approvals for CSF-based Tau CLIA diagnostic tests are established in the EU and USA. Multiple IVD manufacturers are developing plasma pTau-217 CLIA assays following landmark validation studies. Tau-W32P supports development for both CSF and plasma matrix formats.
Tau CLIA sandwich assays are used in two clinical contexts: high-sensitivity CSF Tau measurement (tTau range 100–2,000 pg/mL in AD) and ultra-sensitive plasma Tau measurement (pTau-217 range 0.1–5 pg/mL, requiring Simoa or advanced CLIA). Tau-W32P supports antibody pair development for both platforms. For ultra-sensitive plasma assays, the ≥95% purity of Tau-W32P minimises background in high-sensitivity CLIA formats. Visit our Platforms page for Sekbio's antibody development capabilities.
Tau-W32P is manufactured under Sekbio's ISO 13485 QMS with full Certificate of Analysis per lot. ISO 13485 documentation supports CE IVD, NMPA, and FDA regulatory submissions. The global Alzheimer's disease diagnostics market exceeds USD 3 billion and is growing rapidly with the approval of amyloid-targeting therapies (lecanemab, donanemab) that require accurate Tau biomarker co-testing. Contact info@sekbio.com to discuss OEM supply agreements for Tau CLIA development.
Recombinant Tau-W32P protein validated for Alzheimer's disease CLIA assay development, antibody screening, and neurodegeneration IVD kit manufacturing.
CSF tTau (>300 pg/mL) and pTau-181 (>60 pg/mL) are established diagnostic criteria for Alzheimer's disease in the NIA-AA 2018 AT(N) framework and are incorporated into clinical diagnostic guidelines in the EU and USA. IVD manufacturers developing CSF Tau CLIA kits for hospital clinical laboratories serve a growing market driven by the approval of disease-modifying AD therapies (lecanemab, donanemab) that require biomarker-confirmed diagnosis before treatment initiation. Tau-W32P provides the calibration standard and antibody development antigen needed to build high-sensitivity CSF Tau CLIA assays. Contact info@sekbio.com for development support.
CSF Tau measurement by CLIA is the laboratory gold standard for AD biomarker testing. The clinical Elecsys pTau 181 (Roche), Lumipulse (Fujirebio), and INNOTEST (Fujirebio) platforms have established CSF Tau CLIA as the reference method for AD diagnosis in specialist memory clinics. IVD manufacturers developing competitive or alternative CSF Tau CLIA platforms for hospital laboratory use require high-purity recombinant Tau for antibody pair development and multi-point calibration curve construction. Tau-W32P (≥95% purity, 45.8 kDa) provides the quality standard required for CSF matrix development work.
Blood-based plasma pTau-217 and pTau-181 CLIA assays represent the next frontier in AD diagnostics — enabling population-scale AD screening without lumbar puncture. Plasma pTau-217 distinguishes AD from non-AD dementia with >95% accuracy (Hansson et al., NEJM 2023). The clinical launch of plasma AD tests (ALZpath pTau-217, Lumipulse plasma, Quanterix Simoa platforms) is driving IVD manufacturers globally to develop plasma Tau CLIA reagents. Tau-W32P supports antibody screening and pairing for ultra-sensitive plasma Tau CLIA development. For pTau-specific development, contact info@sekbio.com for phospho-Tau variants.
Beyond Alzheimer's disease, Tau pathology is central to a spectrum of neurodegenerative disorders collectively termed tauopathies: progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), frontotemporal dementia with tau inclusions (FTD-tau), and chronic traumatic encephalopathy (CTE) — the latter receiving increasing clinical attention in contact sports athletes and military veterans. Each tauopathy is characterised by distinct patterns of Tau isoform accumulation (3R vs 4R Tau) and phosphorylation. IVD developers building Tau assays for tauopathy differentiation panels benefit from Sekbio's Tau-W32P for antibody screening across the full Tau sequence. Visit our Products page for complementary neurodegeneration IVD raw materials.
Technical and commercial questions from IVD R&D engineers and procurement teams developing Alzheimer's disease and neurodegeneration CLIA assays.
Tau protein (MAPT gene, Microtubule-Associated Protein Tau) is a neuronal axonal protein that stabilises microtubules to support axonal transport. In Alzheimer's disease, Tau undergoes hyperphosphorylation, dissociates from microtubules, and aggregates into neurofibrillary tangles (NFTs) — a hallmark AD pathology feature. Total Tau (tTau) and phosphorylated Tau (pTau-181, pTau-217) in CSF and blood are core AD biomarkers per the NIA-AA 2018 AT(N) framework. The global AD patient population is 55 million (WHO 2023), creating large demand for Tau IVD assays, especially with the approval of amyloid-targeting therapies requiring biomarker-confirmed diagnosis.
Total Tau (tTau) measures all Tau protein forms in CSF or plasma regardless of phosphorylation state, reflecting overall neurodegeneration and axonal damage. Phosphorylated Tau (pTau) measures Tau specifically phosphorylated at disease-relevant sites: pTau-181 (Thr181), pTau-217 (Thr217), pTau-231 (Thr231). pTau is more specific to AD pathology vs non-AD neurodegeneration. The CSF pTau/Aβ42 ratio is the primary T biomarker in the AT(N) framework. Plasma pTau-217 distinguishes AD from non-AD with >95% accuracy and is validated in multiple large studies (Hansson et al., NEJM 2023). For pTau antigen development, contact info@sekbio.com.
Tau-W32P: recombinant full-length human MAPT/Tau protein with C-terminal His tag; E. coli expressed; molecular weight 45.8 kDa; purity ≥95% by SDS-PAGE; lyophilized format; buffer 50 mM Tris-HCl pH 7.5 + 5% trehalose (pre-lyophilization); storage −70°C (preferred) or −20°C. MOQ and pricing on enquiry — contact info@sekbio.com. Certificate of Analysis provided with each lot under ISO 13485 QMS.
Reconstitute Tau-W32P by adding sterile water or 50 mM Tris-HCl pH 7.5 to the lyophilized powder per the Certificate of Analysis volume instruction. Allow vial to equilibrate at room temperature 5–10 minutes, then mix gently — do not vortex (Tau is aggregation-prone under mechanical stress). Centrifuge briefly to collect powder. Aliquot immediately after reconstitution; store aliquots at −70°C for long-term stability or −20°C for short-term use. Avoid repeated freeze/thaw cycles after reconstitution to preserve immunoreactivity and structural integrity.
Storage: −70°C for long-term, −20°C for short-term. Lyophilized format provides superior stability versus liquid formulations during shipping and storage. Avoid repeated freeze/thaw cycles post-reconstitution. MOQ and pricing are customised based on project requirements — contact info@sekbio.com or +86-13590345917 for a quote. Smaller R&D quantities and larger OEM production quantities are both available.
Yes. Sekbio can discuss customised Tau protein variants including phosphorylated Tau forms (pTau-181, pTau-217) and alternative tag or buffer configurations for specialised CLIA development. For Tau antibody pairing — identifying non-competing capture and detection antibodies for tTau or pTau CLIA sandwich assays — Sekbio's antibody development services include hybridoma development and recombinant antibody expression. Contact info@sekbio.com with your Tau IVD project requirements, or visit our Platforms page for the complete service portfolio.
Request the Tau-W32P technical datasheet, enquire about pTau variants, or discuss your Alzheimer's disease IVD development project with our team.