Fetal Fibronectin
[Fetal Fibronectin]
EPTIS factsheet 1177150 | Last revision 2025-03-17 | URL: https://www.eptis.bam.de/pts1177150 https://www.eptis.bam.de/pts1177150
| 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. Point of care (POC) 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. fFN is an adhesive glycoprotein that holds the membranes of the uterus to the fetal membranes. After 35 weeks of pregnancy, it begins to break down naturally, and is detectable in vaginal secretions. A positive result indicates an increased risk of pre-term labour and is useful in aiding patient management. The negative predictive value (NPV) of the test at 10 ng/mL is quoted as 100%, with a NPV at 50 ng/mL of 99.2%. The manufacturers quote a cut-off of >50 ng/mL as a positive result; indicating the likelihood of a preterm birth within the following 14 days. Further information is provided in NICE guideline on preterm labour and birth {NG25} Weqas offers 3 separate programmes, one for qualitative and quantitative fFn and separate programmes for phIGFBP-1 and PAMG-1. 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 For information on POCT PROM https://www.weqas.com/services/poct-eqa/igfbp-1/ or contact@weqas.com | |||||||||||||||
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Health care / medical devices
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| Testing fields |
Medical analysis
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| 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. *PAM-1 Pilot programme for 2025. Currently not accredited. | |||||||||||||||
| 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 *PAM-1 Pilot programme for 2025. Currently not accredited. |
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| 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.