EPTIS
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POCT D-dimer

[POCT D-dimer]

EPTIS factsheet 1177201 | Last revision 2024-09-24 | URL: https://www.eptis.bam.de/pts1177201 https://www.eptis.bam.de/pts1177201

PT provider
PT provider Weqas Weqas
Based in United Kingdom
Language(s)
Remarks D-dimer is a Fibrin Degradation Product (FDP) used to determine whether clot formation has occurred or not. Its clinical application is as part of the diagnosis pathway for venous thromboembolic diseases: Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). The diagnostic cut off is method dependent, however the majority of methods now report a cut off of ≥500 μg/L FEU for a positive D-dimer. Three samples are distributed bimonthly, with at least eighteen samples distributed annually. The panels consist of 6 endogenous pools, selected at D-dimer concentrations to cover negative, at or near the threshold and at a range of pathological concentrations. Each of the pools are distributed on 3 occasions over the year to assess both laboratory and method performance, including linearity, bias, within and between batch imprecision. Key Features: - Samples are supplied ready to use, no pre-analytical preparation is required. - Quantitative and Qualitative reporting available. - Programme assesses both laboratory and method performance, including bias, within and between batch imprecision and linearity. - Endogenous samples commutable across all testing platforms. - Panel covering the pathological range. - Scoring based on Milan Model 3 performance specification. For more information: https://www.weqas.com/services/poct-eqa/d-dimer/ or contact@weqas.com
Keywords
Product groups Health care / medical devices
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
Endogenous human samples Quantitative D-dimer Routine testing methods (recommended)
Qualitative D-dimer Routine testing methods (recommended)
Aims of the PT scheme
Target group of participants Programme assesses both laboratory and method performance, including bias, within and between batch imprecision and linearity.
Linked to specific legislation / standards Accreditation by UKAS based on ISO/IEC 17043.
Additional, subsidiary aims validation of testing methods
Number of participants
Accredited or otherwise reviewed by a 3rd party

Accredited by UKAS on the basis of ISO/IEC 17043 for part of the parameters

Operation is commissioned / requested by
Fees and frequency
Participation fee https://www.weqas.com/participantzone/subscription-charges/
Regularly operated Yes (Frequency: Bimonthly. Samples: 3 x 1.0mL.)
Year of first operation 2011
Contact details of the PT provider
Provider Contact person
Weqas
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Phone: 44 (0) 2920 314750
Fax:
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Phone: 44 (0) 29218 32884
Fax:
Email: laura.lloyd-lewis@wales.nhs.uk laura.lloyd-lewis@wales.nhs.uk
If you find any mistakes please contact the responsible EPTIS coordinator in United Kingdom, Mr Savvas Xystouris. Mr Savvas Xystouris.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5