EPTIS
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HbA1c

[HbA1c]

EPTIS Ringversuch Nr. 142535 | Letze Änderung 2024-09-24 | URL: https://www.eptis.bam.de/pts142535 https://www.eptis.bam.de/pts142535

Name des Anbieters
Name des Anbieters Weqas Weqas
Ansässig in United Kingdom
Sprache(n)
Anmerkungen HbA1c is used for both the diagnosis (Type 2) and monitoring of diabetes (Type 1 & 2) as an initial screen to identify having a risk of developing diabetes. The programme aim is to cover the clinically relevant ranges, encompassing the diagnostic cut-off level, of 48mmol/mol Hb for the diagnosis of diabetes. However, the analytical measuring range will also be assessed where appropriate. Fresh EDTA whole blood from individual diabetic patients and healthy volunteers are distributed monthly/bi-monthly. These samples reflect the wide range of HbA1c seen in healthy individuals and in Diabetic patients. Challenging samples from patients with known Hb variants are also distributed to assess current practice. Samples from volunteers and diabetic patients are distributed to ensure that the concentration range is appropriate for population health check screening, diabetes diagnosis and diabetes patient monitoring. Key Features: - Whole blood samples are collected from healthy volunteers and patients with Type II Diabetes. - Samples cover non-diabetic, diagnostic cut-off level, (48mmol/mol Hb), pathological and analytical ranges. - Case studies including challenging samples with known Hb variants distributed to assess current laboratory practice. - Sigma metric scoring based on clinically relevant Milan Model 1 performance specification. - Programme assesses both laboratory and method performance, including trueness, bias, within and between batch imprecision. - Trueness is assessed using the IFCC secondary reference methods with Sigma metric scoring based on clinically relevant Milan Model 1 performance specification. - Additional samples are distributed annually as part of the European HbA1c Trial to assess the performance across all countries and all manufacturers. The full report is provided as part of the programme. For more information: https://www.weqas.com/services/eqa/hba1c/ or contact@weqas.com
Klassifizierung
Produktgruppen Health care / medical devices
Prüfgebiete Medical analysis
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
Fresh EDTA whole blood HbA1c Routine testing methods (recommended)
Ringversuchsziele
Zielgruppe des Ringversuchs The programme is suitable for all Laboratory and POCT applications.
Relevante Rechtsvorschriften oder Normen Accreditation by UKAS based on ISO/IEC 17043.
Weitere Ziele validation of testing methods
Teilnehmerzahl
Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt)

Akkreditiert durch UKAS auf der Grundlage von ISO/IEC 17043

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch
Kosten
Teilnahmegebühr https://www.weqas.com/participantzone/subscription-charges/
Regelmässig durchgeführt Ja (Frequency: Monthly / Bimonthly. Samples: 3 x 0.2mL / 2 x 0.2mL (2 samples in bimonthly programme))
Der Ringversuch wird durchgeführt seit 1996
Kontaktdaten des Anbieters
Anbieter Kontaktperson
Weqas
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Telefon: 44 (0) 2920 314750
Fax:
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Telefon: 44 (0) 29218 32884
Fax:
E-Mail: laura.lloyd-lewis@wales.nhs.uk laura.lloyd-lewis@wales.nhs.uk
Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für United Kingdom, Mr Savvas Xystouris. Mr Savvas Xystouris.
Haben Sie Fragen? Senden Sie uns eine E-Mail: eptis@bam.de.
Anwendungsversion: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5