Elecsys Troponin T hs Gen 6

JSON twin: https://www.healthaidb.com/software/elecsys-troponin-t-hs-gen-6.json

Company Name

Roche

Product URL

https://diagnostics.roche.com/global/en/products/lab/elecsys-troponin-t-hs-gen-6-pid00001103.html

Company URL

https://www.roche.com

Categories

• diagnostic Support
• laboratory Testing
• cardiology
• Diagnostic
• Clinical Chemistry

Summary

Elecsys Troponin T hs Gen 6 is a high-sensitivity assay developed by Roche for the rapid and accurate diagnosis of acute myocardial infarction (heart attack).

Description

The Elecsys Troponin T hs Gen 6 assay enables clinicians to detect even the smallest changes in troponin levels, a critical biomarker for diagnosing acute myocardial infarction (AMI). It offers high precision and accuracy, with a 9-minute turnaround time for STAT assays, and demonstrates robustness with low lot-to-lot and platform variability. The assay has been globally validated through the TSIX study program, establishing a standardized diagnostic cutoff across diverse populations and settings. Additionally, it exhibits 10 times more resistance to interferences from hemoglobin, reducing the need for resampling. The assay is compatible with various Roche analyzers and complies with current regulatory standards, enhancing traceability and confidence in results.

Api Available

no

Certifications

• FDA 510(k)
• Clinical and Laboratory Standards Institute (CLSI) EP17-A2
• Clinical and Laboratory Standards Institute (CLSI) EP05-A2

Company Founding

1896

Company Offices

• Switzerland
• United States
• Germany
• France
• United Kingdom
• China
• Japan
• India
• Brazil
• Australia

Compliance

• FDA approval
• Clinical and Laboratory Standards Institute (CLSI) EP17-A2
• Clinical and Laboratory Standards Institute (CLSI) EP05-A2

Customers

Data Residency

EU-only

Data Standards

• IFCC high-sensitivity criteria
• FDA approval standards
• Regulatory compliance standards
• Clinical and Laboratory Standards Institute (CLSI) EP17-A2
• Clinical and Laboratory Standards Institute (CLSI) EP05-A2

Deployment Model

• on_prem

Features

• High precision and accuracy for confident decision making
• High sensitivity at even lower troponin levels for accurate, timely results
• Exceeds latest high-sensitivity IFCC criteria
• 10x more resistance to interferences from hemoglobin
• Low lot-to-lot and platform variability
• 3-level quality control
• Long-term compliance with current regulatory standards
• Global validation for consistent cardiac assessment worldwide
• Standardized interpretation of troponin results across diverse populations
• Compatible with various analyzers and settings
• Supports rapid decision-making in acute myocardial infarction diagnosis
• Enhances triage efficiency in emergency care
• Provides life-saving care at the earliest opportunity
• Offers a 30-year legacy in troponin innovation
• First to receive FDA approval for high-sensitivity troponin tests
• Enables detection of even the smallest changes in troponin levels
• Supports clinicians in timely and accurate diagnosis
• Improves patient outcomes in acute coronary syndrome cases
• Reduces need for resampling due to hemoglobin interference resistance
• Demonstrates robustness and reproducibility across different platforms

Id

SW2558

Integration Partners

Integrations

• Cobas e 411 analyzer
• Cobas e 601 analyzer
• Modular analytics serum work areas
• Cobas h232 analyzer
• Cobas e 801 analyzer
• Cobas e 602 analyzer

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Dutch
• Portuguese
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hindi
• Bengali
• Punjabi
• Telugu
• Marathi
• Tamil
• Urdu
• Gujarati

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• 3-level quality control module
• Global validation study module
• Hemoglobin interference resistance enhancement module
• Regulatory compliance tracking module
• Platform variability analysis module
• Acute myocardial infarction diagnostic support module
• Triage efficiency improvement module
• FDA approval tracking module
• Troponin level detection enhancement module
• Patient outcome improvement module

Os Platforms

• Windows
• Linux

Pricing Details

Contact Roche for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• Data anonymization
• Data minimization
• User consent management
• Data access controls
• Data retention policies
• Compliance with privacy regulations
• Secure data storage
• Data sharing policies
• User data rights management
• Data breach notification procedures

Product Code

SW2558

Product Name

Elecsys Troponin T hs Gen 6

Ratings

Regions Available

• global

Related Urls

Release Year

2025

Security Features

• Data encryption
• Access control
• Audit trails
• User authentication
• Data integrity checks
• Compliance with regulatory standards
• Secure data transmission
• Data backup and recovery
• User role management
• System monitoring

Specialties

• Cardiology

Support Channels

System Requirements

Cobas e 411 analyzer, Cobas e 601 analyzer, Modular analytics serum work areas, Cobas h232 analyzer, Cobas e 801 analyzer, Cobas e 602 analyzer, Cobas e 801 analyzer, Cobas e 411 analyzer, Cobas e 601 analyzer, Cobas e 602 analyzer, Cobas e 801 analyzer, Cobas e 411 analyzer, Cobas e 601 analyzer, Cobas e 602 analyzer, Cobas e 801 analyzer, Cobas e 411 analyzer, Cobas e 601 analyzer, Cobas e 602 analyzer, Cobas e 801 analyzer, Cobas e 411 analyzer

Target Users

• clinicians
• laboratory technicians
• emergency department staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "company_name": "Roche",
  "product_url": "https://diagnostics.roche.com/global/en/products/lab/elecsys-troponin-t-hs-gen-6-pid00001103.html",
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  "description": "The Elecsys Troponin T hs Gen 6 assay enables clinicians to detect even the smallest changes in troponin levels, a critical biomarker for diagnosing acute myocardial infarction (AMI). It offers high precision and accuracy, with a 9-minute turnaround time for STAT assays, and demonstrates robustness with low lot-to-lot and platform variability. The assay has been globally validated through the TSIX study program, establishing a standardized diagnostic cutoff across diverse populations and settings. Additionally, it exhibits 10 times more resistance to interferences from hemoglobin, reducing the need for resampling. The assay is compatible with various Roche analyzers and complies with current regulatory standards, enhancing traceability and confidence in results.",
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    "High sensitivity at even lower troponin levels for accurate, timely results",
    "Exceeds latest high-sensitivity IFCC criteria",
    "10x more resistance to interferences from hemoglobin",
    "Low lot-to-lot and platform variability",
    "3-level quality control",
    "Long-term compliance with current regulatory standards",
    "Global validation for consistent cardiac assessment worldwide",
    "Standardized interpretation of troponin results across diverse populations",
    "Compatible with various analyzers and settings",
    "Supports rapid decision-making in acute myocardial infarction diagnosis",
    "Enhances triage efficiency in emergency care",
    "Provides life-saving care at the earliest opportunity",
    "Offers a 30-year legacy in troponin innovation",
    "First to receive FDA approval for high-sensitivity troponin tests",
    "Enables detection of even the smallest changes in troponin levels",
    "Supports clinicians in timely and accurate diagnosis",
    "Improves patient outcomes in acute coronary syndrome cases",
    "Reduces need for resampling due to hemoglobin interference resistance",
    "Demonstrates robustness and reproducibility across different platforms"
  ],
  "optional_modules": [
    "3-level quality control module",
    "Global validation study module",
    "Hemoglobin interference resistance enhancement module",
    "Regulatory compliance tracking module",
    "Platform variability analysis module",
    "Acute myocardial infarction diagnostic support module",
    "Triage efficiency improvement module",
    "FDA approval tracking module",
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    "Patient outcome improvement module"
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  "integrations": [
    "Cobas e 411 analyzer",
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  "compliance": [
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    "Clinical and Laboratory Standards Institute (CLSI) EP05-A2"
  ],
  "security_features": [
    "Data encryption",
    "Access control",
    "Audit trails",
    "User authentication",
    "Data integrity checks",
    "Compliance with regulatory standards",
    "Secure data transmission",
    "Data backup and recovery",
    "User role management",
    "System monitoring"
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    "Data minimization",
    "User consent management",
    "Data access controls",
    "Data retention policies",
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  "release_year": "2025",
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  "id": "SW2558",
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