Quantitative Faecal Hb (FHb)
[Quantitative Faecal Hb (FHb)]
EPTIS factsheet 1177234 | Last revision 2024-09-24 | URL: https://www.eptis.bam.de/pts1177234 https://www.eptis.bam.de/pts1177234
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| PT provider | Weqas Weqas | ||||||
| Based in | United Kingdom | ||||||
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| Remarks | Faecal immunochemical tests (FIT) are designed to detect small amounts of blood in stool samples (faecal occult blood) using antibodies specific to human haemoglobin (Hb). These tests are recommended by NICE to guide referrals for suspected colorectal cancer in symptomatic patients. [DG 30 – quantitative faecal immunochemical tests to guide referral for colorectal cancer in primary care] and in NICE guideline [NG12: Suspected cancer: recognition and referral]. FIT is also recommended by the UK National Screening Committee and has replaced gFOBT as part of the testing strategy for the UK Bowel Cancer Screening Programmes. The base material is organic material which closely mirrors the basic constituents of human faeces to which a known quantity of Hb (as human whole blood) is added. Material at a range of Hb concentrations is prepared to cover the pathological and analytical range for FIT including samples at or near the clinical cut-off of 10 ug Hb /g used for symptomatic testing pathways and the higher cut offs used in asymptomatic population screening programmes. The homogeneous material is dispensed aseptically into buffered vials specific to each instrument manufacturer. The three samples per distribution is designed to assess laboratory and method performance, including linearity, bias, and within batch imprecision. Key Features: - Material closely mirrors the basic constituents of human faeces. - FIT samples are pre loaded into buffered collection tubes specific to each instrument. - Covers the pathological and analytical range for quantitative FIT automated analysers. - Samples challenging clinically relevant cut-offs for symptomatic testing pathways. For more information: https://www.weqas.com/services/eqa/quantitative-faecal-hb-fhb/ or contact@weqas.com | ||||||
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| Product groups |
Health care / medical devices
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| Testing fields |
Medical analysis
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| Aims of the PT scheme | |||||||
| Target group of participants | To assess performance of laboratories undertaking FIT as part of the diagnostic investigation of colorectal cancer in symptomatic patients and in the assessment of specialist centres using FIT for the asymptomatic population screening for colorectal cancer. | ||||||
| Linked to specific legislation / standards | Accreditation by UKAS based on ISO/IEC 17043. | ||||||
| Additional, subsidiary aims | validation of testing methods | ||||||
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| Accredited or otherwise reviewed by a 3rd party |
Accredited by UKAS on the basis of ISO/IEC 17043 for part of the parameters |
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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. Samples: 3. ) | ||||||
| Year of first operation | 2015 | ||||||
| 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.