Pre-term Labour Markers
[Pre-term Labour Markers]
EPTIS factsheet 187835 | Last revision 2025-03-17 | URL: https://www.eptis.bam.de/pts187835 https://www.eptis.bam.de/pts187835
| PT provider | ||||||||||||||||
| PT provider | Weqas Weqas | |||||||||||||||
| Based in | United Kingdom | |||||||||||||||
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| Remarks | 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 | |||||||||||||||
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| 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 | Programme assesses both site and device performance, including bias, within and between batch imprecision and linearity for quantitative analytes. | |||||||||||||||
| Linked to specific legislation / standards | Accreditation by UKAS based on ISO/IEC 17043. *PAMG-1 Pilot programme for 2025. Currently not accredited. | |||||||||||||||
| Additional, subsidiary aims | validation of testing methods and also Quality and comparability of reporting | |||||||||||||||
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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: Bimonthly. Samples: 2 x 1.0ml for phIGFBP-1, 2 x 0.5mL for fFN and PAMG-1. ) | |||||||||||||||
| Year of first operation | 2013 | |||||||||||||||
| 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.