POCT PROM
[POCT PROM]
EPTIS factsheet 1177173 | Last revision 2024-09-24 | URL: https://www.eptis.bam.de/pts1177173 https://www.eptis.bam.de/pts1177173
| PT provider | |||||||
| PT provider | Weqas Weqas | ||||||
| Based in | United Kingdom | ||||||
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| Remarks | Premature rupture of the membranes (PROM) at term occurs in 5 to 10% of pregnancies and pre-term PROM (PROM<37 weeks’ gestation) occurs in approximately a third of all premature births and is associated with significant neonatal morbidity and mortality. Without clear evidence of amniotic fluid loss observed by speculum examination, the diagnosis of PROM can be uncertain and complementary diagnostic tests are recommended [NG25]. Amniotic fluid specific biomarkers tests from PROM commercially available in the UK include insulin-like growth factor binding protein-1 (IGFBP-1 - Actim® PROM) and placental alpha microglobulin-1 (PAMG-1 - AmniSure®). IGFBP-1 is a 25kD protein synthesized in the decidual cells and foetal liver and is secreted into amniotic fluid. This programme covers the qualitative assessment of IGFBP-1. Purified human IGFBP-1 is added to an artificial amniotic fluid buffer base to produce a high positive base. The high positive base is 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. Two samples are distributed bi-monthly, providing 12 samples over the year. Key Features: - Liquid stable samples are supplied ready to use; no pre-analytical preparation is required. - Qualitative reporting available, with interpretations based on cut-offs of 25 ug/L. - Linear related panel distributed covering the clinically relevant range. - Programme assesses diagnostic accuracy at a range of concentrations including near the diagnostic threshold. For more information: https://www.weqas.com/services/poct-eqa/igfbp-1/ or contact@weqas.com For information on Fetal Fibronectin (fFN) and phIGFBP-1: https://www.weqas.com/services/poct-eqa/pre-term-labour-markers/ or contact@weqas.com | ||||||
| Keywords | |||||||
| 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 | The programme assesses the diagnostic accuracy of the test, specificity and sensitivity at a range of IGFBP-1 concentrations including the diagnostic threshold. | ||||||
| Linked to specific legislation / standards | Accreditation by UKAS based on ISO/IEC 17043. | ||||||
| Additional, subsidiary aims | validation of testing methods | ||||||
| Number of participants | |||||||
| 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. ) | ||||||
| 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.