HbA1c
[HbA1c]
EPTIS factsheet 142535 | Last revision 2024-09-24 | URL: https://www.eptis.bam.de/pts142535 https://www.eptis.bam.de/pts142535
| PT provider | |||||||
| PT provider | Weqas Weqas | ||||||
| Based in | United Kingdom | ||||||
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| Remarks | 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 | ||||||
| Keywords | |||||||
| Product groups |
Health care / medical devices
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| Testing fields |
Medical analysis
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| Technical details | |||||||
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| Aims of the PT scheme | |||||||
| Target group of participants | The programme is suitable for all Laboratory and POCT applications. | ||||||
| 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 |
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| Operation is commissioned / requested by | |||||||
| Fees and frequency | |||||||
| Participation fee | https://www.weqas.com/participantzone/subscription-charges/ | ||||||
| Regularly operated | Yes (Frequency: Monthly / Bimonthly. Samples: 3 x 0.2mL / 2 x 0.2mL (2 samples in bimonthly programme)) | ||||||
| Year of first operation | 1996 | ||||||
| Contact details of the PT provider | |||||||
| Provider | Contact person | ||||||
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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 |
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If you find any mistakes please contact the responsible EPTIS coordinator in United Kingdom,
Mr Savvas Xystouris.
Mr Savvas Xystouris.