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ADAMTS13 Assay Implementation & Validation Services

 

Specialist Expertise. Robust Validation. Clinical Confidence.

Accelerate the implementation of reliable ADAMTS13 testing in your laboratory.

Why Use Specialist Support?

ADAMTS13 testing can present challenges that are not always apparent during assay implementation

  1.  Limited availability of suitable patient samples
  2. Low-frequency disease and difficult sample acquisition
  3. Challenging sample matrices
  4. Method-dependent performance characteristics
  5. Establishment of clinically appropriate acceptance criteria
  6. Unexpected method comparison differences
  7. Calibration and quality control considerations
  8. Complex result interpretation
  9. Urgent testing requirements
  10. Documentation and traceability requirements
  11. UKAS and ISO 15189 expectations

OUR SOLUTION

End-to-End ADAMTS13 Implementation & Validation.

Our service covers the complete implementation pathway.


DEFINE → DESIGN → VALIDATE → ANALYSE → IMPLEMENT → GO LIVE → OPTIMISE

Our structured approach includes:

 1. Define

Clinical requirement, intended use and performance objectives.


2. Assess

Platform, methodology, specimen requirements and available evidence.


3. Validate

Design and execute an appropriate analytical verification/validation programme.


4. Analyse

Review data, investigate failures and establish acceptance against predefined criteria.


5. Implement

Develop documentation, SOPs, QC processes and operational workflows.


6. Go Live

Support final readiness review and transition into routine clinical testing.


7. Optimise

Troubleshooting, performance monitoring and ongoing assay improvement.

Delivering Confidence at Every Stage

 Whether you are:

Introducing your first ADAMTS13 service

   or

Expanding an established haemostasis laboratory

                 

we provide the specialist support needed to establish a robust, reproducible and clinically appropriate testing service.

Find out more

Services

Setup & Feasibility

End to end assay validation

End to end assay validation

Review Pricing Model Options, in-house vs commercial testing platforms.

Construct site specific reimbursement challenges and business cases  

End to end assay validation

End to end assay validation

End to end assay validation

Robust CLSI-based validation evidence that gives clinicians confidence in acute TTP decision-making for inhouse or commercial 

ADAMTS13 activity, ADAMTS13 antibody and open/close ADAMTS13 assays.

Method comparsion

End to end assay validation

ADAMTS13 activity- FRET assay implementation

For sites requiring evaluation data against predefined methods utilized at the specialist reference testing  center at UCLH, London.

ADAMTS13 activity- FRET assay implementation

ADAMTS13 activity- FRET assay implementation

ADAMTS13 activity- FRET assay implementation

Set up the gold standard,  FRETS-VWF73  (Fluorescence resonance energy transfer method). 

Regulatory & Accreditation

ADAMTS13 activity- FRET assay implementation

Regulatory & Accreditation

Support CAP / CLIA (US) or ISO 15189 accreditation for the assay 

Validation sample packs

ADAMTS13 activity- FRET assay implementation

Regulatory & Accreditation

Customized sample pack containing a range of ADAMTS13 levels to conduct local verification/validations 

Why Work With Us

ADAMTS13 Expertise

With over 20 years of experience in ADAMTS13 testing, TTP diagnosis, and patient monitoring, our team is recognized for its specialist knowledge in thrombotic thrombocytopenic purpura (TTP) and related disorders.

Working through a collaborative network of clinical and laboratory experts, we provide comprehensive support for ADAMTS13 assay evaluation, validation, implementation, and clinical interpretation.

Our research capabilities are further strengthened through exclusive access to the TTP Registry Biobank, containing more than 200,000 frozen citrated plasma and serum samples, providing a unique resource for diagnostic development, validation studies, and clinical research.


Why Partner with Us?

  • 20+ years of ADAMTS13 and TTP expertise
  • Specialist clinical and laboratory expert network
  • Support for assay development, validation, and implementation
  • Access to a unique TTP biobank of 200,000+ samples
  • Real-world clinical and research insights

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