BD-Tau immunoassay

JSON twin: https://www.healthaidb.com/software/bd-tau-immunoassay.json

Company Name

Beckman Coulter

Product URL

https://www.beckmancoulter.com/products/diagnostics/neurology/bd-tau-immunoassay

Company URL

https://www.beckmancoulter.com

Categories

• diagnostic Support
• neurology
• clinical Research
• laboratory Testing
• Diagnostic
• Research
• Biomarker Analysis

Summary

Beckman Coulter Diagnostics' BD-Tau immunoassay is a fully automated, high-throughput test designed for research use, enabling precise measurement of brain-derived tau protein in plasma samples to advance neurodegenerative disease research.

Description

The BD-Tau immunoassay is a research use only (RUO) test developed by Beckman Coulter Diagnostics to detect brain-derived tau (BD-Tau) protein in plasma samples. BD-Tau is an isoform of tau protein produced exclusively in the brain, making it a specific biomarker for neurodegenerative diseases. The assay is fully automated and compatible with Beckman Coulter's DxI 9000 and Access 2 analyzers, facilitating high-throughput testing in clinical research laboratories. It offers enhanced sensitivity and specificity, with a coefficient of variation (CV) of less than 4% across the testing range. The assay has an analytical measuring range of 0.057 to 300 pg/mL and requires plasma (K2-EDTA) as the sample type. The open reagent pack stability is 31 days when stored at 2 to 10°C. The BD-Tau immunoassay is intended to assist researchers in studying neurodegenerative diseases by providing a reliable method to measure BD-Tau levels in plasma, thereby advancing the understanding of disease mechanisms and potential therapeutic interventions.

Api Available

unknown

Certifications

• FDA 510(k) clearance for DxI 9000 analyzer
• FDA 510(k) clearance for Access 2 analyzer

Company Founding

1935

Company Offices

• United States
• Germany
• France
• United Kingdom
• Japan
• China
• India
• Brazil
• Australia
• South Korea

Compliance

• FDA Breakthrough Device Designation for p-Tau217/β-Amyloid 1-42 plasma ratio test

Customers

Data Residency

US-only

Data Standards

• BD-Tau
• p-Tau217
• NfL
• GFAP
• APOE ε4

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Fully automated BD-Tau immunoassay test
• High throughput capabilities
• Available on DxI 9000 and Access 2 analyzers
• Enhanced sensitivity and specificity with %CV <4% across the testing range
• Assay format: Two-step sandwich
• Recommended sample type: Plasma (K2-EDTA)
• Analytical measuring range: 0.057 – 300 pg/mL
• Open reagent pack stability: 2 to 10°C for 31 days
• Sample volume (uptake): 55 µL
• Time to first result: ~32 minutes on Access 2, ~38 minutes on DxI 9000
• Within-laboratory imprecision (%CV): ~2.3-3.8% on Access 2, ~1.9 – 2.8% on DxI 9000

Id

SW2570

Integration Partners

Integrations

• DxI 9000 analyzer
• Access 2 analyzer

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Chinese
• Japanese
• Korean
• Arabic
• Russian
• Hindi
• Bengali
• Punjabi
• Urdu
• Indonesian
• Turkish
• Vietnamese
• Thai

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• p-Tau217 assay
• NfL assay
• GFAP assay
• APOE ε4 assay

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Pricing details are not publicly disclosed; please contact Beckman Coulter Diagnostics for more information.

Pricing Model

contact vendor

Privacy Features

• Business Associate Agreement (BAA) available
• Data anonymization
• Data minimization

Product Code

SW2570

Product Name

BD-Tau immunoassay

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• Latin America
• Africa

Related Urls

Release Year

Security Features

• Data encryption
• Role-based access control (RBAC)
• Audit logs
• Single sign-on (SSO)
• Two-factor authentication (2FA)

Specialties

• Neurology
• Neurodegenerative Diseases
• Biomarker Research

Support Channels

System Requirements

DxI 9000 analyzer, Access 2 analyzer

Target Users

• researchers
• clinical laboratories
• neurodegenerative disease specialists

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "BD-Tau immunoassay",
  "company_name": "Beckman Coulter",
  "product_url": "https://www.beckmancoulter.com/products/diagnostics/neurology/bd-tau-immunoassay",
  "company_url": "https://www.beckmancoulter.com",
  "related_urls": [],
  "product_code": "SW2570",
  "summary": "Beckman Coulter Diagnostics' BD-Tau immunoassay is a fully automated, high-throughput test designed for research use, enabling precise measurement of brain-derived tau protein in plasma samples to advance neurodegenerative disease research.",
  "description": "The BD-Tau immunoassay is a research use only (RUO) test developed by Beckman Coulter Diagnostics to detect brain-derived tau (BD-Tau) protein in plasma samples. BD-Tau is an isoform of tau protein produced exclusively in the brain, making it a specific biomarker for neurodegenerative diseases. The assay is fully automated and compatible with Beckman Coulter's DxI 9000 and Access 2 analyzers, facilitating high-throughput testing in clinical research laboratories. It offers enhanced sensitivity and specificity, with a coefficient of variation (CV) of less than 4% across the testing range. The assay has an analytical measuring range of 0.057 to 300 pg/mL and requires plasma (K2-EDTA) as the sample type. The open reagent pack stability is 31 days when stored at 2 to 10°C. The BD-Tau immunoassay is intended to assist researchers in studying neurodegenerative diseases by providing a reliable method to measure BD-Tau levels in plasma, thereby advancing the understanding of disease mechanisms and potential therapeutic interventions.",
  "categories": [
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    "Biomarker Analysis"
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  "market_segment": [
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    "smb"
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  "target_users": [
    "researchers",
    "clinical laboratories",
    "neurodegenerative disease specialists"
  ],
  "specialties": [
    "Neurology",
    "Neurodegenerative Diseases",
    "Biomarker Research"
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  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "Latin America",
    "Africa"
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  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Russian",
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    "Punjabi",
    "Urdu",
    "Indonesian",
    "Turkish",
    "Vietnamese",
    "Thai"
  ],
  "pricing_model": "contact vendor",
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  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "Japan",
    "China",
    "India",
    "Brazil",
    "Australia",
    "South Korea"
  ],
  "company_founding": "1935",
  "deployment_model": [
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    "on_prem",
    "hybrid"
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  "os_platforms": [
    "Web",
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    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Fully automated BD-Tau immunoassay test",
    "High throughput capabilities",
    "Available on DxI 9000 and Access 2 analyzers",
    "Enhanced sensitivity and specificity with %CV <4% across the testing range",
    "Assay format: Two-step sandwich",
    "Recommended sample type: Plasma (K2-EDTA)",
    "Analytical measuring range: 0.057 – 300 pg/mL",
    "Open reagent pack stability: 2 to 10°C for 31 days",
    "Sample volume (uptake): 55 µL",
    "Time to first result: ~32 minutes on Access 2, ~38 minutes on DxI 9000",
    "Within-laboratory imprecision (%CV): ~2.3-3.8% on Access 2, ~1.9 – 2.8% on DxI 9000"
  ],
  "optional_modules": [
    "p-Tau217 assay",
    "NfL assay",
    "GFAP assay",
    "APOE ε4 assay"
  ],
  "integrations": [
    "DxI 9000 analyzer",
    "Access 2 analyzer"
  ],
  "data_standards": [
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    "p-Tau217",
    "NfL",
    "GFAP",
    "APOE ε4"
  ],
  "api_available": "unknown",
  "system_requirements": "DxI 9000 analyzer, Access 2 analyzer",
  "compliance": [
    "FDA Breakthrough Device Designation for p-Tau217/β-Amyloid 1-42 plasma ratio test"
  ],
  "certifications": [
    "FDA 510(k) clearance for DxI 9000 analyzer",
    "FDA 510(k) clearance for Access 2 analyzer"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control (RBAC)",
    "Audit logs",
    "Single sign-on (SSO)",
    "Two-factor authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW2570",
  "slug": "bd-tau-immunoassay",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/bd-tau-immunoassay.json"
  }
}