Pre-term Labour Markers
[Pre-term Labour Markers]
EPTIS Ringversuch Nr. 187835 | Letze Änderung 2025-03-17 | URL: https://www.eptis.bam.de/pts187835 https://www.eptis.bam.de/pts187835
| Name des Anbieters | ||||||||||||||||
| Name des Anbieters | Weqas Weqas | |||||||||||||||
| Ansässig in | United Kingdom | |||||||||||||||
| Sprache(n) | ||||||||||||||||
| Anmerkungen | Preterm labour is defined as regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy. Biomarker tests PartoSure, Actim Partus and quantitative Rapid fetal fibronectin (fFN) are intended for use with other clinical information to assess the risk of preterm birth in women with symptoms of preterm labour who have intact amniotic membranes. Weqas offers 3 separate programmes, one for qualitative and quantitative fFn and separate programmes for phIGFBP-1 and PAMG-1. Purified human fFN and semi - purified IGFBP-1 are added to an artificial amniotic fluid buffer base containing anti-proteases, detergents, proteins and preservatives to produce high positive samples. The two high positive samples are further diluted with the negative base to create a series of samples spanning the analytical range. Each of the samples are distributed on 2-3 occasions to allow for the assessment of between batch variability. For PAMG-1, material is sourced from a third supplier and currently not produced in house. Two samples are distributed bi-monthly, providing 12 samples over the year. Challenging samples are distributed at or near the limit of detection and diagnostic thresholds for the qualitative analytes. Key Features: - Liquid stable samples supplied ready to use for fFN and phIGFBP-1; no pre-analytical preparation is required. - Qualitative and Quantitative reporting available. - Linear related panel distributed covering the clinically relevant range. - Programme assesses both site and device performance, including bias, within and between batch imprecision and linearity for quantitative analytes. - Diagnostic accuracy assessed for the qualitative analytes. - Scoring based on Milan Model 3 performance specification. For more information: https://www.weqas.com/services/poct-eqa/pre-term-labour-markers/ or contact@weqas.com | |||||||||||||||
| Klassifizierung | ||||||||||||||||
| Produktgruppen |
Health care / medical devices
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| Prüfgebiete |
Medical analysis
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| Technische Einzelheiten | ||||||||||||||||
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| Ringversuchsziele | ||||||||||||||||
| Zielgruppe des Ringversuchs | Programme assesses both site and device performance, including bias, within and between batch imprecision and linearity for quantitative analytes. | |||||||||||||||
| Relevante Rechtsvorschriften oder Normen | Accreditation by UKAS based on ISO/IEC 17043. *PAMG-1 Pilot programme for 2025. Currently not accredited. | |||||||||||||||
| Weitere Ziele | validation of testing methods and also Quality and comparability of reporting | |||||||||||||||
| Teilnehmerzahl | ||||||||||||||||
| Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt) |
Akkreditiert durch UKAS auf der Grundlage von ISO/IEC 17043 nicht für alle Parameter |
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| Die Durchführung des Ringversuchs ist in Auftrag gegeben durch | ||||||||||||||||
| Kosten | ||||||||||||||||
| Teilnahmegebühr | https://www.weqas.com/participantzone/subscription-charges/ | |||||||||||||||
| Regelmässig durchgeführt | Ja (Frequency: Bimonthly. Samples: 2 x 1.0ml for phIGFBP-1, 2 x 0.5mL for fFN and PAMG-1. ) | |||||||||||||||
| Der Ringversuch wird durchgeführt seit | 2013 | |||||||||||||||
| Kontaktdaten des Anbieters | ||||||||||||||||
| Anbieter | Kontaktperson | |||||||||||||||
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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 |
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Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für United Kingdom,
Mr Savvas Xystouris.
Mr Savvas Xystouris.