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Quantitative Faecal Hb (FHb)

[Quantitative Faecal Hb (FHb)]

EPTIS Ringversuch Nr. 1177234 | Letze Änderung 2024-09-24 | URL: https://www.eptis.bam.de/pts1177234 https://www.eptis.bam.de/pts1177234

Name des Anbieters
Name des Anbieters Weqas Weqas
Ansässig in United Kingdom
Sprache(n)
Anmerkungen 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
Klassifizierung
Produktgruppen Health care / medical devices
Prüfgebiete Medical analysis
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
Organic material spiked with human whole blood Quantitative FIT Routine testing methods (recommended)
Ringversuchsziele
Zielgruppe des Ringversuchs 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.
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 nicht für alle Parameter

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch
Kosten
Teilnahmegebühr https://www.weqas.com/participantzone/subscription-charges/
Regelmässig durchgeführt Ja (Frequency: Monthly. Samples: 3. )
Der Ringversuch wird durchgeführt seit 2015
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